|установка наблюдения за воздухом, для приточного и отработавшего воздуха
||план приёмочного теста
||Acceptance Test Plan
||план валидации ЛС
||действующая надлежащая практика производства
||Current good manufacturing practice
||химическая чистка на месте
||Clean in Place
||руководство по калибровке
||Check out sheet
||спецификация детального проектирования
||Detailed Design Specification
||квалификация проектной документации
||протоколирование тестов и отчёт о квалификации проектирования
||Design Qualification Report
||план квалификации проектирования
||Design Qualification Plan
||протоколирование тестов и отчёт о верификации документов
||Document Verification Report
||план верификации докум.
||Document Verification Plan
||американское ведомство по продуктам питания и ЛС
||US-Food and Drug Administration
||надлежащая практика про- изводства для автоматизи- рованных систем
||Good Automated Manufacturing Practice (guideline)
||коатер фирмы Glatt
||спецификация общего проектирования
||General Design Specification
||спецификация проектирова- ния управл. оборудования
||Hardware Design Specification
ции проектирования управ- ляющего оборудования
||вход / выход
||Input / Output
||квалификация монтажа оборуд. установки и управл.
||протоколирование тестов и отчёт о квалификации монтажа
||Installation Qualification Report
||план квалификации монтажа
||Installation Qualification Plan
||модель обеспечения качества, ориентированное на процесс построение
||International Standard Organisation
||план теста интеграции
||Integration Test Plan
||общая спецификация планирования
||Master Qualification Plan
||заключительный отчёт о мастерквалификации
||Master Qualification Report
||план теста модулей
||Module Test Plan
||Master Validation Protocol
||протоколирование тестов и отчёт о квалификации функционирования
||Operation Qualification Report
||план квалификации функционирования
||Operation Qualification Plan
||технологическая схема и перечень приборов КИП
||Prozessablaufschema und Instrumentenliste
||схема труб-дов и монтажа
||Piping + Installation Schematic
||план выполнения программ
||Top Level Flow Charts
||система управления процессом
||Process Control System
||союз фармацевтической инспекции
||Pharmaceutical Inspection Convention
||Programmable Logical Controller
||измерение и управление процессом
||Process Measurement & Control
||Production Plan Scheduling
||протоколирование тестов и отчёт о квалификации эксплуатации
||Performance Qualification Report
||план квалиф. эксплуатации
||Performance Qualification Plan
||отчёт о квалификации
||справочник по качеству
||проектный план качества
||Quality Project Plan
||супервизорное управление (визуализация) и регистра- ция данных
||Supervisory Control and Data Aquisition
||описание концепции программного обеспечения
||Software Design Specification
||стерилизация в процессе
||Sterilization in Place
||интегрированный уровень безопасности
||Safety Integrated Level
||стандартные рабочие инструкции
||Standard Operation Procedures
||User Requirements Specification
||V-DIAGRAM / V-Modell
||графическое представление действий при квалифика- циях согласно GAMP
||Flow- Diagram according to GAMP
||отчёт о валидации
||всемирная организация здравоохранения
||World health organisation
||автоматизированная мойка на месте
||Washing in place
List of Abbreviations
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
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
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 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)
COS Certificate of Suitability (Europäisches Zertifikatsystem)
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
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
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
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
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
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
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
IOM Inspections Operations Manual
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
ITCC Information Technology Coordinating Committee (CDER)
IVD In Vitro Diagnostics
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
KPI Key Performance Indicator
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
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
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)
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
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
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)
QWP Quality Working Party (des CPMP)
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
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
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
TABD Trans-Atlantic Business Dialogue
TASC Technical Affairs Steering Committee (ISO)
TC Technical Committee (ISO)
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
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
VAI Voluntary action indicated (FDA, Inspektionsbewertung)
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
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
WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)
WNL Within Normal Limits
WTO World Trade Organization
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)
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.
Numerical limits, ranges, or other suitable measures for acceptance of test results.
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.
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.
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.
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.
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.
A software program developed or adapted to the specific requirements of the application.
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.
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.
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.
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.
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.
Total number of viable microorganisms on or in pharmaceutical product prior to sterilisation.
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.
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.
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.
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.
Any product which has completed all processing stages up to, but not including, final packaging.
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 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.
The result from the in-vitro growth of cells isolated from multicellular organisms.
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.
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).
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 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 is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing medicinal products.
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.
The four zones in the world that are distinguished by their characteristic prevalent annual climatic conditions.
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.
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).
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.
An investigational or marketed product (i.e. active control), or placebo, used as a reference in a clinical trial.
Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.
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.
A group of hardware components and associated software, designed and assembled to perform a specific function or group of functions.
A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
Validation carried out during routine production of products intended for sale.
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.
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.
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.
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.
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.
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.
A manufacturer performing some aspect of manufacturing on behalf of the orginal manufacturer.
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.
Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
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.
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.
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas.
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.
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.
A container designed to contain liquefied gas at extremely low temperature.
A container designed to contain gas at a high pressure.
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.
A process that eliminates viable bioburden via use of sporicidal chemical agents.
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.
® Limit of detection.
Relating to separate and discrete information.
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.
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.
The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. ® Active Pharmaceutcal Ingredient.
Conditions relating to clean area classification under conditions of normal production.
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.
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.
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.
Set of related records treated as a unit, stored on tape or disk; synonymous with data set.
A medicinal product which has undergone all stages of production, including packaging in its final container.
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.
Statements of how the computerised system will satisfy functional requirements of the computer-related system.
A process for verifying that software, a system, or a system component performs its intended functions.
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.
Output on paper.
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.
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.
Heating, ventilation, and air conditioning.
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.
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.
Any component present in the intermediate or API that is not the desired entity.
A description of the identified and unidentified impurities present in an ® API.
Contaminated with extraneous biological agents and therefore capable of spreading infection.
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.
Test to determine the functional performance of a filter system.
An application in which each entry calls forth a response from a system or program, as in a ticket reservation system.
A device which permits two or more devices to communicate with each other.
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 expresses within laboratories variations: different days different analysts, different equipment, etc.
Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
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.
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.
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.
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.
The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.
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.
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.
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.
Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source.
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.
Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC.
is the combination of immediate pack and other secondary packaging such as a carton.
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.
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.
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.).
Plant the whole or part of which is used for medicinal purpose.
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.
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.
Medium sized computer.
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.
(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.
Those conditions and activities interfacing directly or indirectly with the system of concern, control of which can affect the system's validated state.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
® In-process control
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.
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.
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.
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.
A substance that induces a febrile reaction in a patient.
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.
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.
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.
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" 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.
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.
A listing in which the treatment assigned to each subject from the randomisation process is identified.
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.
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.
A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates, APIs oder medicinical products.
A comparison, making due allowance for normal variation, between the amount of product or materials theoretically and actually produced or used.
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 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.
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 expresses the precision between laboratories (collaborative studies usually applied to standardization of methodology).
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.
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.
Validation of a process for a product which has been marketed based upon accumulated manufacturing, testing and control batch data.
Sending back to the manufacturer or distributor of a medicinal product which may or may not present a quality defect.
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.
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).
Combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).
The estimation of the risk associated with the identified hazards
Systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling and communicating risk.
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.
Established period for collecting samples
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.
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.
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
Scheduled periods of work or production, usually less than 12 hours in length, staffed by alternating groups of workers.
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.
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.
Programs executable on a computer. Programs are written in any number of different languages.
An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API .
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.
High level language program which the operator can read.
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 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.
An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
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.
Any substance used in the production of a medicinal product, but excluding packaging materials.
Free of any viable organisms. (In practice, no such absolute statement regarding the absence of microorganisms can be proven, see sterilisation.)
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.
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 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.
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.
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.
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).
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.
An activity intended to produce documented assurance that software has appropriate structural integrity.
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.
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.
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.
A liner magnetic storage device rolled onto a reel or cassette.
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.
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).
Ultra-low penetration air filter with minimum 0.3 mm particle retaining efficiency of 99.999 percent.
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.
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.
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.
Document reporting the validation activities, the validation data and the conclusions drawn.
Non-shedding porous material capable of removing viable and non-viable particles from gases passing in and out of a closed vessel.
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.
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.
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.