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Терминология GMP

 

История GMP

 

 

 

поз. сокращение русский английский
1   иттеративный процесс Itterative Process
2   сопровождающий concurrent
3   перспективный Prospektiv
4   ретроспективный Retrospektiv
5 AHU

 

установка наблюдения за воздухом, для приточного и отработавшего воздуха
6 AIN аналоговый вход Analogue Input
7 AOT аналоговый выход Analogue Output
8 AT тест приёмки Acceptance Test
9 ATP план приёмочного теста Acceptance Test Plan
10 AVP план валидации ЛС

Validation Protocol

11 CC контроль изменений Change Control
12 cGMP действующая надлежащая практика производства Current good manufacturing practice
13 CIP химическая чистка на месте Clean in Place
14 CM руководство по калибровке Calibration Manual
15 COS контрольный список Check out sheet
16 DDS спецификация детального проектирования Detailed Design Specification
17 DIN цифровой вход Digital Input
18 DOT цифровой выход Digital Output
19 DQ квалификация проектной документации Design Qualification
20 DQB DQR протоколирование тестов и отчёт о квалификации проектирования Design Qualification Report
21 DQP план квалификации проектирования Design Qualification Plan
22 DV верификация документов Document Verification
23 DVB DVR протоколирование тестов и отчёт о верификации документов Document Verification Report
24 DVP план верификации докум. Document Verification Plan
25 FC технологические схемы Flow Charts
26 FDA американское ведомство по продуктам питания и ЛС US-Food and Drug Administration
27 FS описание обязанностей Functional Specification
28 FUP функциональный план Functional Plan
29 GAMP надлежащая практика про- изводства для автоматизи- рованных систем Good Automated Manufacturing Practice (guideline)
30 GC коатер фирмы Glatt Glatt-Coater
31 GDS спецификация общего проектирования General Design Specification
32 HDS спецификация проектирова- ния управл. оборудования Hardware Design Specification
33 HQ квалификация специфика-
ции проектирования управ- ляющего оборудования
Hardware Qualification
34 HW управляющее оборудование Hardware
35 IO вход / выход Input / Output
36 IQ квалификация монтажа оборуд. установки и управл. Installation Qualification
37 IQB IQR протоколирование тестов и отчёт о квалификации монтажа Installation Qualification Report
38 IQP план квалификации монтажа Installation Qualification Plan
39 ISO 9001/2000 модель обеспечения качества, ориентированное на процесс построение International Standard Organisation
40 IT тест интеграции Integration Test
41 ITP план теста интеграции Integration Test Plan
42 MM общая спецификация планирования Memory Map
43 MQP мастерплан квалификации Master Qualification Plan
44 MQB MQR заключительный отчёт о мастерквалификации Master Qualification Report
45 MT тест модулей Module Test
46 MTP план теста модулей Module Test Plan
47 MVP мастерплан валидации Master Validation Protocol
48 N. A. не применяемо Not applicable
49 OQ квалиф. функционирования Operational Qualification
50 QQB OQR протоколирование тестов и отчёт о квалификации функционирования Operation Qualification Report
51 OQP план квалификации функционирования Operation Qualification Plan
52 P&ID технологическая схема и перечень приборов КИП Prozessablaufschema und Instrumentenliste
53 P+I схема труб-дов и монтажа Piping + Installation Schematic
54 PAG Pharmatronic AG Pharmatronic AG
55 PAP план выполнения программ Top Level Flow Charts
56 PCS система управления процессом Process Control System
57 PIC союз фармацевтической инспекции Pharmaceutical Inspection Convention
58 PL руководитель проекта Projekt Manager
59 PLC программируем. контроллер Programmable Logical Controller
60 PMC измерение и управление процессом Process Measurement & Control
61 PPS план-график производства Production Plan Scheduling
62 PQ квалификация эксплуатации Performance Qualification
63 PQ квалификация процесса Process Qualification
64 PQB PQR протоколирование тестов и отчёт о квалификации эксплуатации Performance Qualification Report
65 PQP план квалиф. эксплуатации Performance Qualification Plan
66 QA обеспечение качества Quality Assurance
67 QB QR отчёт о квалификации Qualifizierungsbericht
68 QH справочник по качеству Quality Handbook
69 QP план квалификациии Quality plan
70 QPP проектный план качества Quality Project Plan
71 QS система качества Quality system
72 RA анализ рисков Risk assessment
73 SCADA супервизорное управление (визуализация) и регистра- ция данных Supervisory Control and Data Aquisition
74 SDS описание концепции программного обеспечения Software Design Specification
75 SIP стерилизация в процессе Sterilization in Place
76 SIL интегрированный уровень безопасности Safety Integrated Level
77 SOP стандартные рабочие инструкции Standard Operation Procedures
78 UM справочник пользователя User Manual
79 URS требования пользователя User Requirements Specification
80 VC контроль версии Version Control
81 V-DIAGRAM / V-Modell графическое представление действий при квалифика- циях согласно GAMP Flow- Diagram according to GAMP
82 VP пилан валидации Validation plan
83 VR отчёт о валидации Validation Report
84 WHO всемирная организация здравоохранения World health organisation
85 WIP автоматизированная мойка на месте Washing in place

 

 

 

List of Abbreviations

A

AAAS American Association for the Advancement of Science

AAPS American Association of Pharmaceutical Scientists

ABAP Advanced Business Application Program

ABPI Association of the British Pharmaceutical Industry

ACOS Advisory Committee on Safety

ACS American Chemical Society

ADE Adverse Drug Experience

ADI Acceptable Daily Intake

ADME Absorption, Distribution, Metabolism and Excretion

ADR Adverse Drug Reaction

AE Adverse Effects (Event, Experience)

AESGP Association Européenne des Spécialités Pharmaceutiques Grand Public (EU)

AFAQ Association Francaise pour l´Assurance de la Qualité

AFD Anticipatory Failure Determination

AFNOR Association Francaise de Normalisation

AFSSA Agence Française de Sécurité Sanitaire des Aliments (Veterinaire)

AFSSAPS Agence Français de Sécurité Sanitaire des Produits des Santé

AGVU Arbeitsgemeinschaft Verpackung und Umwelt (Germany), Working Party on Packaging and Environment

AIBS American Institute of Biological Science

AIF Arbeitsgemeinschaft industrieller Forschungsgemeinschaften (Germany), German Federation of Industrial Research Associations "Otto von Guericke"

AIM Active Ingredient Manufacturer

AIP Application Integrity Policy

AIP Abbreviated Inspection Program

AISI American Iron and Steel Institute

AMA American Medical Association

AMC Airborne Molecular Contamination

AMG Arzneimittelgesetz, German Medicines Act

AMPAC Analytical Methods Post-Approval Changes (FDA)

AMÜSt Arzneimittelüberwachungsstelle, Drug Surveillance

ANADA Abbreviated New Animal Drug Application (FDA)

ANDA Abbreviated New Drug Application (FDA)

ANOVA Analysis of Variance

ANSI American National Standards Institute

AOAC Association of Official Analytical Chemists (US)

AOQ Average Outgoing Quality

AP American Patent

APA Aseptical Processing Area

APEC Asian-Pacific Economic Cooperation

APGI Association de Pharmacie Gallénique Industrielle (F)

AphA American Pharmaceutical Association

API Active Pharmaceutical Ingredient

APIC Active Pharmaceutical Ingredient Council

APISM API-Starting Material

APR Annual Product Review

APSTJ Academy of Pharmaceutical Sciences and Technology, Japan

APV Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. (Germany), International Association for Pharmaceutical Technology

AQL Acceptable Quality Level

AR Annual Report

ASA American Statistical Association

ASAP Administrative Systems Automation Project (FDA)

ASCII American Standards Code for Information Interchange (computer files)

ASEAN Association of South-East Asian Nations

ASHRAE American Society of Heating, Refrigerating and Air-Conditioning Engineers

ASME American Society of Mechanical Engineers

ASQ American Society for Quality

ASQC American Society for Qualitiy Control

ASTM American Society for Testing and Materials

ATCC American Type Culture Collection (microbiological test)

AUC Area under the Curve

B

BACPAC Bulk Actives Post-Approval Changes (FDA)

BAH Bundesfachverband der Arzneimittel-Hersteller e.V., German Medicines Manufacturers' Association

BAM Bundesanstalt für Materialprüfung (Germany), Federal Institute for Material Research and Testing

BAN British Approved Names

BARQA British Association of Research Quality Assurance

BAT Best Available Techniques

BBA Biologische Bundesanstalt (Germany), Federal Biological Research Centre

BCC Blind Carbon Copy

BDCS Biopharmaceutic Drug Classification System

BfArM Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medicinal Devices

BFS Blow-Fill-Seal (Herstellungstechnik)

BGA Bundesgesundheitsamt , Federal Public Health Department, (now: Robert Koch Institute: RKI)

BgVV Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, since 1994: Federal Office of Consumer Protection and Food Safety (BVL) and Federal Institute for Risk Assessment (BfR)

BIO Biotechnology Industry Organization (US)

BIRA British Institute of Regulatory Affairs

BLA Biologics Licence Application (FDA)

BMF Biologics Master File

BMG Bundesministerium für Gesundheit (Germany), Federal Ministry of Health and Social Security

BNF British National Formulary

BP British Pharmacopoeia

BPC British Pharmaceutical Codex

BPC Bulk Pharmaceutical Chemical

BPCC Bulk Pharmaceutical Chemicals Committee

BPE Bulk Pharmaceutical Excipients

BPF Bonnes Pratiques de Fabrication

BPI Bundesverband der Pharmazeutischen Industrie e.V., German Pharmaceutical Industry Association

BQF British Quality Foundation

BR Batch Record

BRR Batch Record Review

BSC Balanced Scorecard

BSI British Standards Institute

BUA Beratergremium für umweltrelevante Altstoffe (Germany), Advisory Committee on Existing Chemicals (BUA)

BVmed Bundesfachverband Medizinprod. Industrie e. V. , Federal Association of the Medical Device Industry in Germany

BWP Biotechnology Working Party

C

CAB Conformity Assessment Body

CAD Computer-Aided Design

CADREAC Collaboration Agreement between Drug Regulatory Authorities of European Union Associated Countries

CAE Computer-Aided Engineering

CAM Computer-Aided Manufacturing

CANDA Computer-Assisted New Drug Application

CAO Computer-Aided Office Automation

CAP Computer-Aided Planning

CAPA Corrective action preventive action

CAPLA Computer-Assisted Product Licence Application

CAPRA Canadian Association of Pharmaceutical Regulatory Affairs

CAQ Computer-Aided Quality (-assurance, -management)

CAS Chemical Abstracts Service

CAS Change Approval System

CATT Computer-Aided Test Tool

CBER Center for Biologics Evaluation and Research (FDA)

CBT Computer-Based Training

CDC Center for Desease Control (US)

CDER Center for Drug Evaluation and Research (FDA)

CDM Clinical Data Management

CDP Clinical Development Plan

CDRH Center for Devices and Radiological Health (FDA)

CE Commission Européenne

CEC Commission of the European Communities (EC)

CEFIC Conseil Européen des Fédérations de l´Industrie Chimique (European Chemical Industries Council)

CEN Comité Européen de Normalisation

CENELEC Comité Européen de Normalisation Electro-technique

CEO Chief Executive Officer

CEP Certificate of the European Pharmacopoeia

CFR Code of Federal Regulations (US)

CFSAN Center for Food Safety and Applied Nutrition (FDA)

CFU Colony Forming Units

cGMP current Good Manufacturing Practice

cGMPR current Good Manufacturing Practice Regulation

CIA Chemical Industries Association Ltd (GB)

CID CTFA Cosmetic Ingredient Dictionary

CIM Computer Integrated Manufacturing

CIP Cleaning-In-Place

CIP Continuous Improvement Process

CIR Cosmetic Ingredient Review

CISA Committee on International Scientific Affairs (US)

CISQ Certificazione Italiana dei Sitemi Qualita delle Aziende

CMC Chemistry, Manufacturing and Controls

CMCCC CMC Coordinating Committee (CDER)

CMS Change Management System

CMS Content Management System

CNC Computerized Numerical Control

Cod Franc Codex Français

COE Code of Ethics

COIMS Centerwide Oracle Management Information System (FDA)

COP Cleaning-out-of-Place

COS Certificate of Suitability (Europäisches Zertifikatsystem)

COTS Computer-off-the-Shelf

CPD Chemical Pharmaceutical Documentation

CPGM Compliance Program Guidance Manual (FDA)

CPMP Committee for Proprietary Medicinal Products (EMEA)

CPSC Consumer Product Safety Commission (US)

CRA Clinical Research Associate

CRADA Cooparative Research and Development Agreement (with NIH)

CRC Child Resistant Closure

CRF Case Report Form

CRM Clinical Research Monitor

CRM Customer Relationship Management

CRO Contract Research Organization

CRS Controlled Release Society (US)

CSA Canadian Standards Association

CSDD Center for the Study of Drug Development

CSO Consumer Safety Officer (FDA)

CSVC Computer System Validation Committee (der PhRMA)

CTD Common Technical Document

CTFA The Cosmetic, Toiletry and Fragrance Association

CTX Clinical Trial Exemption

CV Computer Validation

CVM Center of Veterinary Medicine (FDA)

CVMP Committee for Veterinary Medicinal Products (EC)

CWQC Company-Wide Quality Control

D

DAB Deutsches Arzneibuch, German Pharmacopoeia

DAC Deutscher Arzneimittel Codex, German Pharmaceutical Codex

DACH Deutsche Akkreditierungsstelle Chemie, German Accreditation Body, Chemistry

DAP Deutsches Akkreditierungssystem Prüfwesen, German Accreditation System for Testing

DAR Deutscher Akkreditierungsrat, German Accreditation Council

DCS Distributed Control Systems

DDMAC Division of Drug Marketing, Advertising and Communications (FDA)

DG III Directorate-General III

DGHM Deutsche Gesellschaft für Hygiene und Mikrobiologie, German Society for Hygiene and Microbiology

DGQ Deutsche Gesellschaft für Qualität, German Society for Quality

DGRA Deutsche Gesellschaft für Regulatorische Angelegenheiten, German Society for Regulatory Affairs

DHHS Department of Health and Human Services (US)

DHSS Department of Health and Social Security

DIA Drug Information Association

DIE Investigational Device Exemption (FDA)

DIMDI Deutsches Institut für Medizinische Dokumentation und Information, German Institute of Medical Documentation and Information

DIN Deutsches Institut für Normung, German Institute for Standardization

DIS Draft International Standard (ISO)

DIW Deionisiertes Wasser, Deionised Water

DKD Deutscher Kalibrierdienst, German Calibration Service

DMF Drug Master File
(Type I = processes, Type II = facilities and equipment)

DMPQ Division of Manufacturing and Product Quality (FDA)

DMS Dokumenten Management System

DOC Dissolved Organic Carbon

DOE Design of Experiments

DPhG Deutsche Pharmazeutische Gesellschaft, German Pharmaceutical Society

DQ Design Qualification

DQS Deutsche Gesellschaft zur Zertifizierung von Qualitätsmanagementsystemen, German Society for Certification of Management Systems

DRA Drug Regulatory Authorities

DS Drug Substance

DSI Division of Scientific Investigation (FDA)

DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen, German National Resource Centre for Biological Material; German Collection of Microorganisms and Cell Cultures

DSNP Development of Standardized Nomenclature Project (FDA)

DTC Direct to Consumer (z. B. Arzneimittelbestellung via Internet)

DTD Document Type Definition (for electronic interchange)

DVG Deutsche Veterinärmedizinische Gesellschaft, German Veterinary Medical Society

E

EA Environmental Assessment

EAC European Accreditation Committee

EAL European Cooperation for Accreditation of Laboratories

EAPB European Association of Pharma Biotechnology

EBR Electronic Batch Record

EBRS Electronic Batch Recording System

EBSA European Biosafety Association

EC European Commission

EC European Communities

ECCC European Community Chemistry Committee (EC)

ECCLS European Committee for Clinical Laboratory Standards

ECETOC European Chemical Industry Ecology and Toxicology Center

ECL Exposure Control Limit

ECPHIN European Community Pharmaceutical Products Information Network

EDI Electronic Data Interchange

EDM Engineering Data Management

EDMF European Drug Master File

EDMS Eletronic Data Management System

EDP Electronic Data Processing

EDQM European Directorate for the Quality of Medicines

EEA European Economic Association

EEC European Economic Community (EC)

EFA European Food Authority

EFPIA European Federation of Pharmaceutical Industries` Association

EFQM European Foundation for Quality Management

EFTA European Free Trade Area

EGA European Generic Medicines Association

EHC Environmental Health Criteria

EHEDG European Hygienic Equipment Design Group

EHPM European Federation of Health Product Manufacturers` Association

EINECS European Inventory of Existing Chemical Substances

EIR Establishment Inspection Report (US-FDA)

ELA Establishment License Application (FDA, Biologics)

ELV Exposure Limit Value

EMAS European Eco Management and Audit Scheme

EMEA European Medicines Evaluation Agency (European Agency for the Evaluation of Medicinal Products)

EMR Elektronische Mess- und Regeltechnik, Measurement and Control Technology

EMS Enviromental Management System

EOL Exchange of Letters (FDA)

EOQ European Organization for Quality

EOTC European Organization for Testing and Certification

EP European Parliament

EP European Patent

EP European Pharmacopoeia

EPA Environmental Protection Agency (US)

EPAR European Public Assessment Report

EPC`s Event driven Process Chains

EPO European Patent Office

EQA European Quality Award

EQS Environmental Quality Standards

ERES Electronic Records, Electronic Signature

ERP Enterprise Resource Planning

ESCOP European Scientific Cooperative for Phytotherapy

ESRA European Society of Regulatory Affairs

ESTRI Electronic Standards for Transmission of Regulatory Information

EU European Union

EUCOMED European Confederation of Medical Device Manufacturers Associations

EUFEPS European Federation for Pharmaceutical Sciences

EUGMP European Union Good Manufacturing Practice

EUROPAMA European Packaging Machinery Manufacturers Association

EWP Efficacy working party

F

FAO Food and Agriculture Organization (UN)

FAQ Frequently Asked Questions

FAT Factory Acceptance Testing

FCA Field Corrective Action

FCC Food and Chemical Codex

FCCSET Federal Coordinating Council for Science, Engineering and Technology

FCI Food and Chemical Index

FCIO Fachverband der chemischen Industrie Österreich (A) - Chemieverband, Association of the Austrian Chemical Industry - FCIO

FD&C Act (US) Food, Drug and Cosmetic Act

FDA Food and Drug Administration (US)

FDAMA Food and Drug Administration Modernization Act

FDS Functional Design Specification

FEFO First Expired-First Out

FEM Federation Europeenne de la Manutention

FFDCA Federal Food, Drug and Cosmetic Act (FDA)

FIC/FCN Fédération des Industries Chimiques de Belgique/
Federatie Chemische Nijverheid van Belgie (B)

FICI Federation of Irish Chemical Industries (Ei)

FIFO First In-First Out

FIP Féderation Internationale Pharmaceutique

FIR Forschungsinstitut für Rationalisierung e.V., Research Institute for Operations Management

FMEA Failure Mode and Effect Analysis (Fehler-Möglichkeits- und Einfluss-Analyse)

FOI Freedom of Information

FOIA Freedom of Information Act (US)

FPAP First Party Audit Program (US-FDA)

FPMAJ Federation of Pharmaceutical Manufacturers` Association of Japan

FR Federal Register

FS Functional Specification

FTA Fault Tree Analysis

FTC Federal Trade Commission (US)

FU Farmacopea Ufficiale della Republica Italiana

G

GALP Good Automated Laboratory Practices (EPA)

GAMP Good Automated Manufacturing Practice (ISPE)

GATT General Agreement on Tariffs and Trade

GCLP Good Control Laboratory Practice

GCP Good Clinical Practice

GCS Good Common Sense

GCVP Good Computer Validation Practice

GDP Good Distribution Practice

GGP Good Guidance Practice (FDA)

GLP Good Laboratory Practice

GMP Good Manufacturing Practice

GPHF German Pharma Health Fund

GPIA Generic Pharmaceutical Industry Association (US)

GRAS Generally Recognized as Safe

GRASE Generally Recognized as Safe and Effective

GRP Good Review Practice

GSIA Gesellschaft der Schweizerischen Industrie-Apotheker(innen), Swiss Society of Industrial Pharmacists

GSP Good Storage Practice

GSP Good Scientific Practice

GTP Good Transportation Practice

GWQAP Government-Wide Quality Assurance Program

GxP Good "x" Practice, where "x" one of: Clinical, Distribution, Laboratory, Manufacturing

H

HACCP Hazard Analysis Critical Control Point

HAT Hardware Acceptance Testing

HAZOP Hazard and Operability Analysis

HCFA Health Care Financing Administration (US)

HDGMP Human Drug GMP Notes (US-FDA)

HDS Hardware Design Specification

HEPA-Filter High Efficency Particulate Air-Filter

HIMA Health Industry Manufacturers Association

HMTL Hypertext Markup Language (IT)

HPB Health Protection Bureau (Canada)

HPLC High Performance Liquid Chromatography

HTS High-Throughput Screening

HVAC Heating, Ventilation and Air-Conditioning

I

IAAR Independent Association of Accredited Registrars (US)

IASG International Automotive Sector Group

IB Investigator`s Brochure

ICC International Chamber of Commerce

ICH International Conference on Harmonization

ICSC International Chemical Safety Cards

IEC International Electrotechnical Commission

IEEE Institute for Electrical and Electronics Engineers

IFPMA International Federation of Pharmaceutical Manufacturers Associations

IGPA International Generic Pharmaceutical Alliance

IMB Irish Medicines Board

IND Investigational New Drug

INDA Investigational New Drug Application (FDA)

INDC Investigational New Drug Committee (FDA)

INN International Nonproprietary Names

I/O Input/Output

IOM Inspections Operations Manual

IPC In-Process-Control

IPCS International Programme on Chemical Safety

IPEC International Pharmaceutical Excipients Council

IPRA International Product Registration Document

IPRO Independent Pharmaceutical Research Organization

IQ Installation Qualification

IQA International Quality Assurance

IRB Institutional Review Board (FDA)

IRD International Registration Document

IRIS Integrated Risk Information System

IRS Identical, Related or Similar

ISDN Integrated Services Digital Network

ISO International Standards Organization

ISPE International Society for Pharmaceutical Engineers

IT InformationTechnology

ITCC Information Technology Coordinating Committee (CDER)

IVD In Vitro Diagnostics

J

JAN Japanese Accepted Names

JIT Just in Time

JNIH Japan National Institute of Health

JP The Pharmacopoeia of Japan

JPMA Japan Pharmaceutical Manufacturers Association

JSG Joint Sectoral Group

JUSE Japanese Union of Scientists and Engineers

K

KPI Key Performance Indicator

L

LAN Local Area Network

LF Laminar Flow

LIMS Laboratory information management system

LIR Laboratory Investigation Report

LOC Level of Concern

LOD Limit of Detection

LOEL Lowest Observable Effect Level

LOQ Limit of Quantitation

LRV Logarithmic Reduction Value

LTL Lower Tolerance Limit

LVP Large Volume Parenteral

M

MA Marketing Authorization

MACO Maximum Acceptable Carry-Over

MAIL Medicines Act Information Letter

MAL Medicines Act Leaflets

MaPPS Manual of Policies and Procedures (FDA)

MBC Minimum Bactericidal Concentration

MBO Management by Objectives

MBR Master Batch Record

MCA Medicines Control Agency (UK)

MDA Medical Devices Agency (UK)

MDD Medical Device Directives (EU)

MDR Medical Device Report

MedDRA Medical Dictionary for Regulatory Activities

MEP Member of the European Parliament

MES Manufacturing Execution System

MHW Ministery of Health and Welfare „Koseisho" (Japan)

MIC Minimum Inhibitory Concentration

MJA Mutual Joint Audit (EU)

MJV Mutual Joint Visit (EU)

MMP Microbiological Monitoring Programme

MOA Memoranda of Agreement (FDA)

MOC Memoranda of Cooperation (FDA)

MOH Ministry of Health

MOU Memoranda of Unterstanding (FDA)

MPA Medical Product Agency (Sweden)

MPI Master Production Instruction

MRA Mutual Recognition Agreement

MRFG Mutual Recognition Facilitation Group (CPMP-Group)

MSDS Material Safety Data Sheet

MSSO Management Support and Services Organization (ICH)

MTBF Mean Time Between Failure

MTD Maximum Tolerated Dose

N

NACCB National Accreditation Council for Certification Bodies

NADA New Animal Drug Application

NAI No Action Indicated (FDA, Inspektionsbewertung)

NAMAS National Measurement Accreditation Service

NAMUR Normen-Arbeitsgemeinschaft für Mess- und Regeltechnik in der Chemischen Industrie (Germany), Standardization association for measurement and control in chemical industries; new: Standardization association for measurement and control in chemical and pharmaceutical industries

NAPM National Association of Pharmaceutical Manufacturers (US)

NAS New Active Substance

NATRIK National Reporting and Investigation Centre (UK)

NBS National Bureau of Standards

NCE New Chemical Entity

NCTC National Collection of Type Cultures (UK)

NDA New Drug Application

NDE New Drug Evaluation (FDA)

NDMA Nonprescription Drug Manufacturers Association

NDS New Drug Study

NEL No Effect Level

NF National Formulary

NHS National Health Service (GB)

NHW National Health and Welfare Department (Canada)

NIBSC National Institute for Biological Standards and Control (UK)

NIH National Institute of Health (US)

NIOSH National Institute for Occupational Safety and Health (US)

NIST National Institute for Standards and Technology (US)

NME New Molecular Entity

NND New and Nonofficial Drugs

NNR New and Nonofficial Remedies

NOEL No Observable Effect Level

NPA National Pharmaceutical Alliance (US)

NRC National Research Council (US)

NSF National Sanitation Foundation (US)

NSR Nonsignificant Risk

NTIS National Technical Information Service (US)

O

OAI Official Action Indicated (serious FDA postinspection classification)

ODE Office of Drug Evaluation (FDA)

OECD Organization for Economic Cooperation and Development

OEM Original Equipment Manufacturer

OIML Organisation Internationale de Métrologie Légale

OLE Object Linking and Embedding

OMCL Official Medicinal Control Laboratories

OMO Office of Management and Operations (FDA)

ONDC Office of New Drug Chemistry (CDER)

OOS Out of Specification (-Result)

OPC OLE for Process Control

OPCD Optimized Preclinical Development

OPS Office of Pharmaceutical Science (CDER)

OQ Operational Qualification

ORA Office of Regulatory Affairs (FDA)

OS Operating System

OSAT On-Site Acceptance Test

OSHA Occupational Safety and Health Administration

OTC Over-the-Counter

P

P.& I.D. Piping and Instrument Diagram

PA Prior Approval (US-FDA)

PAA Premarket Approval Application

PAB Pharmaceutical Affairs Bureau

PAC-ATLS Post-Approval Changes Analytical Testing Laboratory Sites (FDA)

PAC-PAC Packaging Post-Approval Changes (FDA)

PAC-SAS Post-Approval Changes for Sterile Aqueous Solutions (FDA)

PAD Pharmacological Active Dose

PAI Pre-Approval Inspection

PAITS Pre-Approval Inspection Tracking System (FDA)

PAR Proven Acceptable Range

PAS Prior Approval Supplement (SUPAC)

PBR Production Batch Record

PC Programming Committee (ISO)

PCS Process Control System

PDA Parenteral Drug Association (US)

PDA Production Data Aquisition

PDE Permitted Daily Exposure

PDF Portable Document Format

PDG Pharmacopoeial Discussion Group (ICH)

PDR Physicians` Desk Reference

PDUFA Prescription Drug User Fee Act (US)

PEI Paul Ehrlich-Institut

PERF Pan European Regulatory Forum

PF Pharmacopée Française

PFD Process Flow Diagram

Ph Belg Pharmacopée Belge

Ph Dan Pharmacopoea Danica

Ph Eur Pharmacopoea Europaea

Ph F Pharmacopoea Fennica

Ph Franc s. PF

Ph Helv Pharmacopoea Helvetica

Ph Ned Pharmacopoea Nederladica

Ph Nord Pharmacopoea Nordica

Ph Norv Pharmacopoea Norvegica

Ph Svec Pharmacopoea Svecica

PhRMA Pharmaceutical Research and Manufacturing Association (US)

PHS Public Health Service (US)

PHSA Public Health Service Act (FDA)

PhVWP Pharmacovigilance Working Party

PIC Pharmaceutical Inspection Convention

PIC/S Pharmaceutical Inspection Cooperation Scheme

PICSVF Pharmaceutical Industry Computer Systems Validation Forum (UK)

PL Product License

PLA Product License Application

PLC Programmable Logic Controller

PM Project Manager

PMA Pharmaceutical Manufacturers Association

PMA Premarket Approval Application

PMS Postmarketing Surveillance

PMS Project Management System

PNDS Preclinical New Drug Submission

POG Pharmacopoeial Discussion Group (ICH)

PPI Patient Package Insert

PQ Performance Qualification

PQG Pharmaceutical Quality Group (UK)

PQRI Product Quality Research Institute (US)

PR Public Relations

PSJ Pharmaceutical Society of Japan

PTO Patent and Trademark Office (US)

PV Process Validation

Q

QA Quality Assurance

QA/RA Quality Assurance and Regulatory Affairs

QAC Quality Acceptance Criteria

QAU Quality Assurance Unit

QC Quality Control

QCA Quality Correlation Analysis

QCU Quality Control Unit

QE Quality Engineering

QFD Quality Function Deployment

QHD Qualified Hygienic Design

QM Quality Management

QMS Quality Management System

QP Qualified Person

QSIT Quality System Inspection Technique (FDA)

QSR Quality Systems Regulation (US-FDA, Devices)

QUAL Qualification

QWP Quality Working Party (des CPMP)

R

R & D Research and Development

RA Regulatory Affairs

RABC Risk Analysis and Biocontamination Control System

RAPS Regulatory Affairs Professionals Society (US)

RAS Rapid Alert System (EU)

RC Responsible Care

RKI Robert Koch Institute (Germany)

RL Regulatory Letter (FDA postaudit letter)

RLU Relative Light Units

RMS Reference Member State

RMS Regulatory Management System (FDA)

RMS Risk Management System

RPN Risk Priority Number

RTP Rapid Transfer Port (e.g. isolator, glove box)

RTU Ready to Use

S

SAG.E Senior Advisory Group - Environment (CEFIC)

SAG.T Senior Advisory Group - Trade (CEFIC)

SAGE Strategic Advisory Group on Environment

SAL Sterility Assurance Level

SAT Site Acceptance Testing

SBA Summary Basis of Approval

SCADA Supervisory, Control and Data Acquisition

SCM Supply Chain Management

SD Standard Deviation

SDS Safety Data Sheet

SDS Software Design Specification

SE Standard Error

SELS Surface Evaluation of Living Skin

SEMI Semiconductor Equipment and Materials International

SFSTP Société Francaise des Sciences et Techniques Pharmaceutique' Industrie (F)

SG Sector Group (CEFIC)

SGCI/SSIC Schweizerische Gesellschaft für Chemische Industrie
Societé Suisse des Industries Chimiques, Swiss Society of Chemical Industries

SIP Sterilization-In-Place

SLA Service Level Agreement

SLS Swedish Drug Standard

SMART Submission Management and Review Tracking (FDA)

SMART Selfmonitoring and Report Technology

SMO Site Management Organization

SmPC Summary of Product Characteristics

SNDA Supplemental New Drug Application (FDA)

SNIP Syndicat National de I'Industrie Pharmaceutique (F)

SOP Standard Operating Procedure

SPC Statistical Process Control

SPC Summary of Product Characteristics

SQ Specification Qualification

SRM Standard Reference Material

STC Clean Steam

STT Short Term Tests

SUPAC (IR, MR, SS) Scale-Up and Post-Approval Changes (FDA),
(immediate release solid oral dosage forms;
modified release; semisolid dosage forms)

SVP Small Volume Parenteral

SWOT Strengths, Weaknesses, Opportunities, Threats

SWP Safety Working Party

T

TABD Trans-Atlantic Business Dialogue

TASC Technical Affairs Steering Committee (ISO)

TC Technical Committee (ISO)

TCO Total-Cost-of-Ownership

TDI Tolerable Daily Intake

TEP Tender Evaluation Panel (ICH)

TGA (Australian) Therapeutic Goods Administration

TIA Totally Integrated Automation

TM Test Method

TOC Total Organic Carbon

TOC Table of Contents

TPM Total Productive Maintenance

TQD Total Quality Deployment

TQM Total Quality Management

TWA Time Weighted Average

U

UBA Umweltbundesamt, German Federal Environment Agency (FEA)

UIC Union des Industries Chimiques (F)

UMDNS Universal Medical Device Nomenclature System

UN United Nations

UNESCO United Nations Educational Science and Cultural Organization

UNICE Union of Industries of the European Community

URS User Requirement Specification

USN U.S. Adopted Names

USC United States Code (book of laws)

USDA United States Department of Agriculture

USEPA United States Environmental Protection Agency

USP Unique Selling Proposition

USP United States Pharmacopeia

USP-DI United States Pharmacopoeia-Drug Information

USP-NF United States Pharmacopoeia-National Formulary

UTL Upper Tolerance Limit

V

VAI Voluntary action indicated (FDA, Inspektionsbewertung)

VAL Validation

VC Visibly Clean (Akzeptanzkriterium)

VDI Verband Deutscher Ingenieure, Association of German Engineers

VFA Verband Forschender Arzneimittelhersteller e.V., German Association of Research-based Pharmaceutical Companies

VMP Validation Master Plan

VOC Volatile Organic Compounds

VP Validation Plan

VR Validation Report

W

WBT Web Based Training

WCB Working Cell Bank

WDI Water Distilled

WELMEC Western European Legal Metrology Cooperation

WFI Water for Injection

WHO World Health Organization

WIP Washing-In-Place

WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)

WNL Within Normal Limits

WTO World Trade Organization

X

Y

Z

ZLG Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Central Coordination Unit of the Laender regarding Medicinal Products for Human and Animal use (Germany)


Accelerated testing

 Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at nonaccelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes.

Acceptance criteria

 Numerical limits, ranges, or other suitable measures for acceptance of test results.

Accuracy

 The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness.

Action level

 Established criteria, e.g. microbial or particulate levels, requiring immediate follow-up and corrective action if exceeded.

Action level (in clean rooms)

 An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.

Active Pharmaceutical Ingredient (API) (or drug substance)

 Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Advanced electronic signature

 means an electronic signature, which meets the following requirements:
(a) it is uniquely linked to the signatory;
(b) it is capable of identifying the signatory;
(c) it is created using means that the signatory can maintain under his control; and
(d) it is linked to the data to which it relates in such a manner that any change of the data is detectable.

Air lock

 An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling the air-flow between those rooms when they need to be entered. An air lock is designed for and used by either people or goods.

Alert level

 An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels.

Alert limits (environmental monitoring)

 Established microbial or particulate levels giving early warning of potential drift from normal operating conditions which are not necessarily grounds for definitive corrective action but which require follow-up investigation.

Alert limits (media fill)

 Established levels or numbers of positive media filled units, the cause of which should be investigated, but which are not necessarily grounds for definitive corrective action.

Analytical procedure

 The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.

API Starting Material

 A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure.

Applications (for computersystems)

 Term used to describe software written to perform tasks on a computer.

Application-specific software

 A software program developed or adapted to the specific requirements of the application.

Asepsis

 A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product.

Aseptic filling

 Operation whereby the product is sterilised separately, then filled and packaged using sterilised containers and closures in critical processing zones.

Aseptic processing facility

 A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.

Aseptic processing room

 A room in which one or more aseptic activities or processes is performed.

Aseptic manufacturing area

 The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms.

Automated system

 Term used to cover a broad range of systems, including automated manufacturing equipment, control systems, automated laboratory systems manufacturing execution systems and computers running laboratory or manufacturing database systems. The automated system consists of the hardware, software and network components, together with the controlled functions and associated documentation. Automated systems are sometimes referred to as computerised systems.

Barrier

 A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area.

Batch (or Lot)

 A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.
Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity.
For control of the finished product, the following definition has been given in Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC: `For the control of the finished product, a batch of a proprietary medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time'.

Batch number (or lot number)

 A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distri bution history can be determined.

Batch release

 Each batch of finished product must be certified by a ® Qualified person within the EU before being released for sale or supply in the EU or for export.

Bioburden

 Total number of viable microorganisms on or in pharmaceutical product prior to sterilisation.

Biogenerator

 A contained system, such as a fermenter, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition and material withdrawal.

Biological agents

 Micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not.

Biological Indicator (BI)

 A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.

Blinding

 A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and doubleblinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). In relation to an investigational medicinal product, blinding shall mean the deliberate disguising of the identity of the product in accordance with the instructions of the sponsor. Unblinding shall mean the disclosure of the identity of blinded products.

Bracketing

 The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system.

Bulk product

 Any product which has completed all processing stages up to, but not including, final packaging.

Calibration

 The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard.

Cell bank

 
Cell bank system: A cell bank system is a system whereby successive batches of a product are manufactured by culture in cells derived from the same master cell bank. A number of containers from the master cell bank are used to prepare a working cell bank. The cell bank system is validated for a passage level or number of population doublings beyond that achieved during routine production.
Master cell bank: A culture of [fully characterised] cells distributed into containers in a single operation, processed together in such a manner as to ensure uniformity and stored in such a manner as to ensure stability. A master cell bank is usually stored at -70 °C or lower.
Working cell bank: A culture of cells derived from the master cell bank and intended for use in the preparation of production cell cultures. The working cell bank is usually stored at -70 °C or lower.

Cell culture

 The result from the in-vitro growth of cells isolated from multicellular organisms.

Change control

 A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.

Change management

 A less formal approach to change control that is generally utilised during the preliminary planning and design stage of a project. (Many companies will elect to move straight to a change control system in a design stage of a complex project. This has the advantage of formality, more accurate records and documentation as well as a strong traceability and accountability feature).

Clean area

 An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area.

Clean zone

 ® Clean Area.

Clean/contained area

 An area constructed and operated in such a manner that will achieve the aims of both a clean area and a contained area at the same time.

Cleaning Validation

 Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing medicinal products.

Cleanroom

 A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.

Climatic zones

 The four zones in the world that are distinguished by their characteristic prevalent annual climatic conditions.

Clinical trial

 Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of one or more investigational medicinal product(s) with the object of ascertaining its/their safety and/or efficacy.

Colony Forming Unit (CFU)

 A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. One colony forming unit is expressed as 1 CFU.

Commissioning

 An engineering term that covers all aspects of bringing a system or sub-system to a position where it is regarded as being ready for use in pharmaceutical manufacture. Commissioning involves all the basis requirements of Installation Qualification (IQ) and Operational Qualification (OQ).

Commitment batches

 Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application.

Comparator product

 An investigational or marketed product (i.e. active control), or placebo, used as a reference in a clinical trial.

Component

 Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.

Computer hardware

 Various pieces of equipment in the computer system, including the central processing unit, the printer, the modem, the cathode ray tube (CRT), and other related apparatus.

Computer system

 A group of hardware components and associated software, designed and assembled to perform a specific function or group of functions.

Computerised system

 A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.

Concurrent validation

 Validation carried out during routine production of products intended for sale.

Configuration

 The documented physical and functional characteristics of a particular item, or system, e.g. software, computerised system, hardware, firmware and operating system. A change converts one configuration into a new one.

Configuration management

 The process of identifying and defining the configuration items in a system, controlling the release and change of these items throughout the system life cycle, recording and reporting the status of configuration items and change requests, and verifying the completeness and correctness of configuration items.

Confirmatory studies

 are those undertaken to establish photostability characteristics under standardized conditions. These studies are used to identify precautionary measures needed in manufacturing or formulation and whether light resistant packaging and/or special labeling is needed to mitigate exposure to light. For the confirmatory studies, the batch(es) should be selected according to batch selection for long-term and accelerated testings.

Contained area

 An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of the external environment by biological agents from within the area.

Container closure system

 The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system.

Containment

 The action of confining a biological agent or other entity within a defined space.
Primary containment: A system of containment which prevents the escape of a biological agent into the immediate working environment. It involves the use of closed containers or safety biological cabinets along with secure operating procedures.
Secondary containment: A system of containment which prevents the escape of a biological agent into the external environment or into other working areas. It involves the use of rooms with specially designed air handling, the existence of airlocks and/or sterilisers for the exit of materials and secure operating procedures. In many cases it may add to the effectiveness of primary containment.

Contamination

 The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

Contract manufacturer

 A manufacturer performing some aspect of manufacturing on behalf of the orginal manufacturer.

Controlled area

 An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

Cross-contamination

 Contamination of a starting material, intermediate product or finished product with another starting material or product during production.

CPU

 Central processing unit of a computer where the logic circuitry is located; the CPU controls the entire computer; it sends and receives data through input-output channels, retrieves data from memory and conducts all program processes.

Critical

 Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the product meets its specification.

Critical area

 An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas.

Critical surfaces

 Surfaces that may come into contact with or directly affect a sterilized product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing.

Critical variable study

 A study that serves to measure variables (parameters) critical to the satisfactory operation of a piece of equipment or plant and to assure their operation within monitored and controlled limits. Examples of variables would be pressure, temperature, flow rates, time etc.

Cross contamination

 Contamination of a material or of a product with another material or product.

Crude plant (vegetable drug)

 Fresh or dried medicinal plant or parts thereof.

Cryogenic vessel

 A container designed to contain liquefied gas at extremely low temperature.

Cylinder

 A container designed to contain gas at a high pressure.

D value

 The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.

Decontamination

 A process that eliminates viable bioburden via use of sporicidal chemical agents.

Depyrogenation

 A process used to destroy or remove pyrogens (e.g., endotoxin).

Design Qualification (DQ)

 The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.

Detection limit

 ® Limit of detection.

Digital

 Relating to separate and discrete information.

Disinfection

 Process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores.

Dosage form

 A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients.

Drug (medicinal) product

 The dosage form in the final immediate packaging intended for marketing.

Drug substance

 The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. ® Active Pharmaceutcal Ingredient.

Dynamic

 Conditions relating to clean area classification under conditions of normal production.

Electronic signature

 An electronic measure that can be substituted for a handwritten signature or initials for the purpose of signifying approval, authorisation or verification of specific data entries. See also definition for "Advanced Electronic Signature" above.
Electronic signature (EU): 1999/93/EC states: `electronic signature' means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication. (® Active Pharmaceutcal Ingredient. also `Advanced Electronic Signature')
Electronic signature (FDA): 21 CFR Part11 defines this as: The computer data compilation of any symbol or series of symbols executed, adopted, or authorised by an individual to be the legally binding equivalent of the individual's hand-written signature.

Endotoxin

 A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death.

Environmental monitoring programme

 Defined documented programme which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded.

Excipient

 A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to:

  • aid in the processing of the drug delivery system during its manufacture;
  • protect, support or enhance stability, bioavailability, or patient acceptability;
  • assist in product identification; or
  • enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
Expiry date (or expiration date)

 The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.

File

 Set of related records treated as a unit, stored on tape or disk; synonymous with data set.

Finished product

 A medicinal product which has undergone all stages of production, including packaging in its final container.

Firmware

 A software program permanently recorded in a hardware device, such as an EPROM. (Note: EPROM stands for `Erasable Programmable Read Only Memory')

Forced degradation testing studies

 are those undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation.

Formal stability studies

 Long term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the re-test period of a drug substance or the shelf life of a drug product.

Functional requirements (ANSI/IEEE)

 Statements that describe functions a computer-related system must be capable of performing.

Functional specifications

 Statements of how the computerised system will satisfy functional requirements of the computer-related system.

Functional testing

 A process for verifying that software, a system, or a system component performs its intended functions.

Gowning qualification

 A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.

Growth promotion test

 Test performed to demonstrate that media will support microbial growth.

Hard copy

 Output on paper.

Hardware

 Physical electronic circuitry and associated equipment.

Hardware acceptance test specification

 Statements for the testing of all key aspects of hardware installation to assure adherence to appropriate codes and approved design intentions and that the recommendations of the regulated user have been suitably considered.

Hardware design specification

 Description of the hardware on which the software resides and how it is to be connected to any system or equipment.

HEPA filter

 High efficiency particulate air filter with minimum 0.3 mm particle retaining efficiency of 99.97 percent.

Herbal medicinal product

 Medicinal product containing, as active ingredients, exclusively plant material and/or vegetable drug preparations.

High efficiency particulate air (HEPA) filter

 Retentive matrix designed to remove a defined percentage of particulate matter of a defined size.

HVAC

 Heating, ventilation, and air conditioning.

I/O Port

 Input/output connector.

Immediate (primary) pack

 is that constituent of the packaging that is in direct contact with the drug substance or drug product, and includes any appropriate label.

Impermeable containers

 Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions.

Impurity

 Any component present in the intermediate or API that is not the desired entity.

Impurity profile

 A description of the identified and unidentified impurities present in an ® API.

Infected

 Contaminated with extraneous biological agents and therefore capable of spreading infection.

In-process control

 Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control.

Installation Qualification (IQ)

 The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer's recommendations.

Integrated circuit (IC)

 Small wafers of silicon etched or printed with extremely small electronic switching circuits; also called CHIPS.

Integration testing (IEEE)

 An orderly progression of testing in which software elements, hardware elements, or both are combined and tested until the entire system has been integrated.

Integrity test

 Test to determine the functional performance of a filter system.

Interactive processing

 An application in which each entry calls forth a response from a system or program, as in a ticket reservation system.

Interface

 A device which permits two or more devices to communicate with each other.

Interface (ANSI/IEEE)

 A shared boundary. To interact or communicate with another system component.

Intermediate (for APIs)

 A material produced during steps of the processing of an ® API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated.

Intermediate precision

 Intermediate precision expresses within laboratories variations: different days different analysts, different equipment, etc.

Intermediate product

 Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.

Intermediate testing

 Studies conducted at 30 °C/60 % RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25 °C.

Interpreter

 A program which translates a high level language into machine code one instruction at a time. Each instruction in the high level language is executed before the next instruction is interpreted.

Intervention

 An aseptic manipulation or activity that occurs at the critical area.

Investigational medicinal product

 A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.

Isolator

 A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). There are two major types of isolators: Closed isolator systems exclude external contamination from the isolator's interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations.
Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.

Labelling

 The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.

Laminar flow

 An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight line vector.

Legacy computerised systems

 These are regarded as systems that have been established and in use for some considerable time. For a variety of reasons, they may be generally characterised by lack of adequate GMP compliance related documentation and records pertaining to the development and commissioning stage of the system. Additionally, because of their age there may be no records of a formal approach to validation of the system.

Life cycle concept

 An approach to computer system development that begins with identification of the user's requirements, continues through design, integration, qualification, user validation, control and maintenance, and ends only when commercial use of the system is discontinued.

Limit of detection

 The lowest amount of analyte in a sample which can be detected but not quantitated as an exact value. The Limit of Detection is mostly a parameter of limit tests.

Linearity

 The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.

Liquefiable gases

 Those which, at the normal filling temperature and pressure, remain as a liquid in the cylinder.

Long term testing

 Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling.

Manifold

 Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source.

Manufacture

 All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls.
For API: All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls.

Manufacturer

 Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC.

Marketing pack

 is the combination of immediate pack and other secondary packaging such as a carton.

Mass balance

 The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical error.

Material

 A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labelling materials.

Mean kinetic temperature

 A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation. When establishing the mean kinetic temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927-929, 1971) can be used.

Media fills

 Method of evaluating an aseptic process using a microbial growth medium. (Media fills are understood to be synonymous to simulated product fills, broth trials, broth fills etc.).

Medicinal plant

 Plant the whole or part of which is used for medicinal purpose.

Medicinal product

 Any substance or combination of substances presented for treating or preventing disease in human beings or animals.
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

Microprocessor

 Usually a single integrated circuit on a chip; logic circuitry of a microcomputer; frequently synonymous with a microcomputer. A microprocessor executes encoded instructions to perform arithmetic operations, internal data transfer, and communications with external devices.

Minicomputer

 Medium sized computer.

Mother liquor

 The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing.

Network

 
(a) An interconnected, or interrelated group of nodes.
(b) An interconnected communications facility. A Local Area Network (LAN) is a high bandwidth (allowing a high data transfer rate) computer network operating over a small area such as an office or group of offices.

New molecular entity

 An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance.

Operating environment

 Those conditions and activities interfacing directly or indirectly with the system of concern, control of which can affect the system's validated state.

Operating system

 A set of software programs provided with a computer that function as the interface between the hardware and the applications program.

Operational Qualification (OQ)

 The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

Operator

 Any individual participating in the aseptic processing operation, including line set-up, filler, maintenance, or other personnel associated with aseptic line activities.

Overkill sterilization process

 A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minimum D value of 1 minute.

Packaging

 All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product.
Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not finally packaged, primary containers.

Packaging material

 Any material employed in the packaging of a medicinal product, excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

Parametric Release

 A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release.

Performance Qualification (PQ)

 The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.

Pharmaceutical product

 Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.

Pilot scale batch

 A batch of a drug substance or drug product manufactured by a procedure fully representative of and simulating that to be applied to a full production scale batch. For solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full production scale or 100,000 tablets or capsules, whichever is the larger.

Piping & Instrument Diagrams

 P&IDs) Engineering schematic drawings that provide details of the interrelationship of equipment, services, material flows, plant controls and alarms. The P&ID also provide the reference for each tag or label used for identification.

Plant functional specifications

 Specifications that document functions, standards and permitted tolerances of systems (plant) or system components (equipment) and which define the operating capabilities of the equipment.

Precision

 The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.
Precision should be investigated using homogeneous, authentic samples. However, if it is not possible to obtain a homogeneous sample it may be investigated using artificially prepared samples or a sample solution.
The precision of an analytical procedure is usually expressed as the variance, standard deviation or coefficient of variation of a series of measurements.

Pre-determined acceptance criteria

 The criteria assigned, before undertaking testing, to allow evaluation of test results to demonstrate compliance with a test phase of delivery requirement.

Primary batch

 A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a re-test period or shelf life, respectively. A primary batch of a drug substance should be at least a pilot scale batch. For a drug product, two of the three batches should be at least pilot scale batch, and the third batch can be smaller if it is representative with regard to the critical manufacturing steps. However, a primary batch may be a production batch.

Procedure

 Description of the operations to be carried out, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of a medicinal product, an intermediate or API.

Process aids

 Materials, excluding solvents, used as an aid in the manufacture of an intermediate or API that do not themselves participate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc).

Process Capability Index (CpK)

 A process capability index CpK represents the true measure of process capability
CpK = (X - LSL)/3s
or = (USL - X)/3s
where
LSL = Lower specification limit
USL= Upper specification limit
X = Mean
s = Standard deviation

Process capability study

 A process capability study is a statistical method that compares process information (e.g. X and s) to the upper and lower specification limits.

Process control

 ® In-process control

Process Validation

 The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

Production

 All operations involved in the preparation of a medicinal product, from receipt of materials, through processing and packaging, to its completion as a finished product.

Production batch

 A batch of a drug substance or drug product manufactured at production scale by using production equipment in a production facility as specified in the application.

Product specification file

 A reference file containing, or referring to files containing, all the information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal product.

Prospective validation

 Establishing documented evidence that a process, procedure, system, equipment or mechanism used in manufacture does what it purports to do based on a pre-planned validation protocol.

Pyrogen

 A substance that induces a febrile reaction in a patient.

Qualification

 Identification of equipment attributes related to the performance of a particular function or functions and allocation of certain limits or restrictions to those attributes.'

Qualified Person (Q.P.)

 The person defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.

Quality Assurance (QA)

 The sum total of the organised arrangements made with the object of ensuring that all products are of the quality required for their intended use and that quality systems are maintained.

Quality control unit

 An organizational element with authority and responsibility as defined by 211.22.

Quality unit(s)

 An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.

Quantitation limit

 The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.

Quarantine

 The status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal.

Radiopharmaceutical

 "Radiopharmaceutical" shall mean any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose (Article 1(6) of Directive 2001/83/EC.

Randomisation

 The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Randomisation code

 A listing in which the treatment assigned to each subject from the randomisation process is identified.

Range

 The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.

Raw data

 Any work-sheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities and which are necessary for the reconstruction and evaluation of a work project, process or study report, etc. Raw data may be hard/paper copy or electronic but must be known and defined in system procedures.

Raw material

 A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates, APIs oder medicinical products.

Reconciliation

 A comparison, making due allowance for normal variation, between the amount of product or materials theoretically and actually produced or used.

Recovery

 The introduction of all or part of previous batches of the required quality into another batch at a defined stage of manufacture.

Reference standard, primary

 A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be obtained from an officially recognised source or prepared by independent synthesis, or obtained from existing production materials of high purity, or prepared by further purification of existing production material.

Reference standard, secondary

 A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

Repeatability

 Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision

Reprocessing (for APIs)

 Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an in-process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing.

Reprocessing

 The reworking of all or part of a batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations.

Reproducibility

 Reproducibility expresses the precision between laboratories (collaborative studies usually applied to standardization of methodology).

Retest date

 The date after which samples of the drug substance should be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given drug product.

Retest period

 The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions. After this period, a batch of drug substance destined for use in the manufacture of a drug product should be re-tested for compliance with the specification and then used immediately. A batch of drug substance can be retested multiple times and a different portion of the batch used after each re-test, as long as it continues to comply with the specification. For most biotechnological/biological substances known to be labile, it is more appropriate to establish a shelf life than a re-test period. The same may be true for certain antibiotics.

Retrospective validation

 Validation of a process for a product which has been marketed based upon accumulated manufacturing, testing and control batch data.

Return

 Sending back to the manufacturer or distributor of a medicinal product which may or may not present a quality defect.

Revalidation

 A repeat of the process validation to provide an assurance that changes in the process/equipment introduced in accordance with change control procedures do not adversely affect process characteristics and product quality.

Reworking

 Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

Risk

 Combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).

Risk analysis

 The estimation of the risk associated with the identified hazards

Risk management

 Systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling and communicating risk.

Robustness

 The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

Sampling frequency

 Established period for collecting samples

Seed lot

 
Seed lot system: A seed lot system is a system according to which successive batches of a product are derived from the same master seed lot at a given passage level. For routine production, a working seed lot is prepared from the master seed lot. The final product is derived from the working seed lot and has not undergone more passages from the master seed lot than the vaccine shown in clinical studies to be satisfactory with respect to safety and efficacy. The origin and the passage history of the master seed lot and the working seed lot are recorded.
Master seed lot: A culture of a micro-organism distributed from a single bulk into containers in a single operation in such a manner as to ensure uniformity, to prevent contamination and to ensure stability. A master seed lot in liquid form is usually stored at or below -70 °C. A freezedried master seed lot is stored at a temperature known to ensure stability.
Working seed lot: A culture of a micro-organism derived from the master seed lot and intended for use in production. Working seed lots are distributed into containers and stored as described above for master seed lots.

Semi-permeable container

 Containers that allow the passage of solvent, usually water, while preventing solute loss. The mechanism for solvent transport occurs by absorption into one container surface, diffusion through the bulk of the container material, and desorption from the other surface. Transport is driven by a partial-pressure gradient. Examples of semi-permeable containers include plastic bags and semirigid, low-density polyethylene (LDPE) pouches for large volume parenterals (LVPs), and LDPE ampoules, bottles, and vials.

Sensitivity

 Capacity of the test procedure to record small variations in concentration of a component, with a defined degree of precision.

Shelf life (also referred to as expiration dating period)

 The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label

Shift

 Scheduled periods of work or production, usually less than 12 hours in length, staffed by alternating groups of workers.

Signature (signed)

 The record of the individual who performed a particular action or review. This record can be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature.

Simulated product

 A material that closely approximates the physical and, where practical, the chemical characteristics (e.g. viscosity, particle size, pH etc.) of the product under validation. In many cases, these characteristics may be satisfied by a placebo product batch.

Software

 Programs executable on a computer. Programs are written in any number of different languages.

Solvent

 An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API .

Source code

 An original computer program expressed in human-readable form (programming language), which must be translated into machine-readable form before it can be executed by the computer.

Source program

 High level language program which the operator can read.

Specification

 A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. "Conformance to specification" means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Specification - release

 The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug product at the time of its release.

Specification - shelf life

 The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its shelf life.

Specificity

 Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s). This definition has the following implications:
Identification: To ensure the identity of an analyte.
Purity tests: To ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e., related substances test, heavy metals, residual solvents content, etc.
Assay (content or potency): To provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample.

Sponsor

 An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.

Standalone system

 A self-contained computer system, which provides data processing, monitoring or control functions but which is not embedded within automated equipment. This is contrasted with an embedded system, the sole purpose of which is to control a particular piece of automated equipment.

Starting material

 Any substance used in the production of a medicinal product, but excluding packaging materials.

Sterile

 Free of any viable organisms. (In practice, no such absolute statement regarding the absence of microorganisms can be proven, see sterilisation.)

Sterile product

 For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.

Sterilisation

 Validated process used to render a product free of viable organisms. Note: In a sterilisation process, the nature of microbiological death of reduction is described by an exponential function. Therefore, the number of microorganisms which survive a sterilisation process can be expressed in terms of probability. While the probability may be reduced to a very low number, it can never be reduced to zero.

Sterility

 Sterility is the absence of living organisms. The conditions of the sterility test are given in the European Pharmacopoeia.

Sterility Assurance Level (SAL)

 Probability that a batch of product is sterile. (SAL is expressed as 10-n)

Sterility assurance system

 The sum total of the arrangements made to assure the sterility of products. For terminally sterilized products these typically include the following stages:
(a) Product design.
(b) Knowledge of and, if possible, control of the microbiological condition of starting materials and process aids ( e.g. gases and lubricants ).
(c) Control of the contamination of the process of manufacture to avoid the ingress of microorganisms and their multiplication in the product. This is usually accomplished by cleaning and sanitization of product contact surfaces, prevention of aerial contamination by handling in clean rooms, use of process control time limits and, if applicable, filtration stages.
(d) Prevention of mix up between sterile and non sterile product streams.
(e) Maintenance of product integrity.
(f) The sterilization process.
(g) The totality of the Quality System that contains the Sterility Assurance System e.g. change control, training, written procedures, release checks, planned preventative maintenance, failure mode analysis, prevention of human error, validation calibration, etc.

Sterility test

 Test performed to determine if viable microorganisms are present.

Sterilising grade filter

 A filter that, when appropriately validated, will remove all microorganisms from a fluid stream, producing a sterile effluent.

Storage

 The storing of pharmaceutical products and materials up to their point of use.

Storage condition tolerances

 The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guideline. The actual temperature and humidity (when controlled) should be monitored during stability storage. Short term spikes due to opening of doors of the storage facility are accepted as unavoidable. The effect of excursions due to equipment failure should be addressed, and reported if judged to affect stability results. Excursions that exceed the defined tolerances for more than 24 hours should be described in the study report and their effect assessed.

Storage device

 A unit into which can be placed, retained and retrieved.

Stress testing (drug product)

 Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing on certain products, (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products).

Stress
testing (drug substance)

 Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing.

Structural verification

 An activity intended to produce documented assurance that software has appropriate structural integrity.

Supporting data

 Data, other than those from formal stability studies, that support the analytical procedures, the proposed re-test period or shelf life, and the label storage statements. Such data include stability data on early synthetic route batches of drug substance, small scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing; information regarding test results on containers; and other scientific rationales.

Supplier

 A person providing pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be authorized by a competent authority.

System

 Is used in the sense of a regulated pattern of interacting activities and techniques which are united to form an organised whole.
For computer systems: Term can refer to hardware or software. For hardware it is the collection of equipment that makes up the computer. For software it refers to an integrated number of computer programs to perform predefined tasks.

System acceptance test specification

 The system acceptance test specification is a description of those tests to be carried out to permit acceptance of the system by the user. Typically it should address the following:

  • System functionality
  • System performance
  • Critical parameters
  • Operating procedures

The tests should ensure that the product operates as indicated in the functional specification and meets the user requirements as defined in the URS. The tests typically include limit, alarms and boundary testing.

The System Acceptance Test Specification is a contractual document and, as such, should be approved by both the supplier/ developer/ integrator and the end user.

Tape

 A liner magnetic storage device rolled onto a reel or cassette.

Terminal

 A device, usually equipped with a CRT display and keyboard, used to send and receive information to and from a computer via a communication channel.

Terminal sterilization

 The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of greater than one in a million).

ULPA filter

 Ultra-low penetration air filter with minimum 0.3 mm particle retaining efficiency of 99.999 percent.

Unidirectional flow

 An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.

Validation

 Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
For cumputer systems: The assurance, through testing, that hardware or software produces specified and predictable output for any given input.

Validation master plan

 A document providing information on the company's validation work programme. It should define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated.

Validation protocol

 A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.

Validation report

 Document reporting the validation activities, the validation data and the conclusions drawn.

Vent filter

 Non-shedding porous material capable of removing viable and non-viable particles from gases passing in and out of a closed vessel.

Worst case

 A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.

Yield, expected

 The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale, or manufacturing data.

Yield, theoretical

 The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production.


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