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GMP-conforming documentation

 

Here you will find answers to the following questions:

  • Why is GMP conforming documentation important?
  • Under what general conditions may handwritten documents also be compiled?
  • How are corrections in a document to be carried out?
  • Example: Master SOP - "GMP conforming documentation"

The general conditions for GMP conforming documentation are described in chapter 4 of the EU GMP Guideline: "Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance."

Moreover, the completeness of documents must be checked and ensured - particularly in the case of batch-related documents consisting of many individual pages and additional appendices.

15.B.1 Handwritten entries

Entries of raw data in records and log books are often written by hand. These entries should be clear, easy to read, complete, free from errors, distinct (self-explanatory) and indelible. Sufficient space should also be provided for such entries. Additionally, to prevent incorrect information, there must be a close temporal correlation between the procedure to be documented and all entries made.

A document-quality pen should be used to make handwritten entries. The requirement in the past that has been frequently raised to use only blue ink pens - in order to be able to differentiate between originals and copies - has survived the test of time due to the high quality of laser printers that nowadays are frequently standard equipment in many offices and often print in colour. To prevent confusion, copies should be labelled (authorised copy, verified copy), initialled and dated by the compiler.

This same applies for corrections to entries, the original information should remain legible once the correction has been made.

The reason for the correction must also be documented. In order to make subsequent checks of the documentation easier, it is useful to introduce uniform abridgements for specific corrections such as:

TY typographical error
TE transfer error
CE calculation error
SUP supplementation

Any form of entry may be considered as raw data including printouts from balances or temperature recorders, chromatograms and measurement records. The documents that make up the raw data itself are more important than their evaluations and summaries. In each case they must be stored as prescribed and be accessible as required.

The transfer of original data from loose rough notes (e. g. Post-it notes") to original documents at a later date is prohibited.

Empty fields (without entry) must be invalidated by crossing them out once and initialling the deletion (date, initials, and reason for deletion if required).

15.B.2 Archiving

Documents relevant to the manufacturing and analysis of medicinal products (also includes equipment-related documents, qualification and validation documentation), must be stored for at least one year after the expiration date of the medicinal product. This is normally six years; for test preparations, this is at least five years following completion or cancellation of the last clinical investigation for which the batch was used. Many companies retain the documentation for longer in case evidence is required in a legal dispute. It is in the interests of the company to retain development documents longer than any other documents as the development process itself often lasts for several years and it must be possible to demonstrate a continuous history of development.

The premises in which the documentation is stored must not be accessible to unauthorised persons and must be protected against fire or water damage. If the documents are archived on optical media or magnetic tapes, they must be available for the duration of the prescribed period, this means that suitable readers must also be archived and data must be copied over from the media once a specific running time has elapsed to prevent ageing effects.

Thermal paper is not suitable for archiving (not document quality). Relevant documents must be copied on to normal paper, and an initialled copy must be included in the documentation alongside the original.

15.B.3 Master-SOP - "GMP-conforming documentation"

Figure 15.B-1 Sample SOP - "GMP conforming documentation"  

Company name

Logo

Standard operating procedure

SOP no. QS-AD-017-03

Title

GMP conforming documentation

valid from 1. January 2005

Page x of y

 

Appendices: none

Replaces SOP no. QS-AD-017-02

Binding for
Production
Quality control
Formulation
Quality assurance

To Central documentation
for information

Dr. Redneb

Quality assurance/
documentation officer

06.12.2004

 

created by

Job/role

Date

Signature

Dr. Rehtiep

Quality assurance/
Head of Documentation

07.12.2004

 

checked by

Job/role

Date

Signature

Dr. Saam

Quality assurance/
Head of department

08.12.2004

 

approved

Job/role

Date

Signature

Change index

  • editorial review
  • new date notation

Table of contents
1. Introduction
1.1 Background, objectives
1.2 Links to other regulations
1.3 Scope
1.4 Definitions

2 Implementation
2.1 General
2.2 Handwritten entries
2.3 Printouts
2.4 Copies
2.5 Corrections
2.6 Date and time notation
2.7 Number notation
2.8 Signatures
2.9 Invalidation of empty fields
2.10 Archiving

1 Introduction

1.1 Background, objectives

According to the rules of good manufacturing practice, documents are an important component of a pharmaceutical quality assurance system. Documents must be free of errors and be available in a written form.

This operating procedure describes the rules for a GMP conforming documentation.

1.2 Links to other regulations

Archiving guideline of business association.

1.3 Scope

This operating procedure applies for all GMP-mandatory documents in the areas of production, quality control, formulation and quality assurance.

1.4 Definitions

GMP-mandatory documents

In the context of this operating procedure, GMP-mandatory documents are documents that must be compiled within the scope of the production and control of medicinal products due to applicable GMP rules.

Examples of GMP-mandatory documents: operating procedures, manufacturing/testing documentation, deviation reports, change control documentation, etc.

2 Implementation

2.1 Generalities

Documentation must be

  • exact,
  • clear,
  • correct,
  • complete,
  • legible and
  • properly signed and dated.

Documents only become valid once all signatures have been furnished. The content of the documents must be clear; also the title and purpose of the document must be clearly indicated. The documents must be clearly laid out. If copies are made, this duplication must not lead to errors. Copies must be clearly legible. Suitable measures must be taken to prevent the use of obsolete invalidated versions. If you find it difficult to understand documents ask your supervisor for an explanation.

Records (e. g. batch processing records) must be compiled or completed at the time of the relevant operation in such a way that all important tasks relevant to the medicinal product can be traced back. The documentation of a working step must correspond to the task undertaken and must be carried out promptly by the person who completed the task.

Documents may not be backdated and may only be dated in advance in exceptional cases (e. g. validity date of an operating procedure). All raw data must be traceable; either by entering the data directly in the relevant document or by including printouts. Checks on data in documents must be carried out very carefully and documented.

2.2 Handwritten entries

Sufficient space must be available for handwritten entries. Handwritten entries must be clear, perfectly legible and indelible. All handwritten entries must be carried out using a document-quality pen (permitted: ball-point pen, felt-tip pen, for example); not permitted: pencil or comparable writing implement).

2.3 Printouts

It must be ensured that printouts used for documentation purposes are sufficiently durable in order to guarantee long-term legibility (corresponding to the prescribed storage period of the document). Thermal paper, for example, does not satisfy this requirement. If these kinds of printouts are the only ones available, suitable copies must be made on normal paper and used for documentation purposes.

It must be possible to clearly assign printouts by means of suitable labelling. Printouts that have been pasted on must be initialled by a staff member so that the initials are visible on the printout as well as the paper to which the printout is affixed.

2.4 Copies

If copies of original documents are made to provide working documents these must not lead to errors. The person who compiles working copies is responsible for keeping these up-to-date. Provisions regarding the copying of operating procedures can be found in the SOP "Compilation and administration of operating procedures".

2.5 Corrections

Each correction to an entry in a document must be initialled and dated. The original information must be legible once the correction has been made. The original content of an entry must not be rendered illegible by scoring it out or by using any other means. Furthermore, accessories such as "ink erasers" must not be used. The pasting-over of original contents is also prohibited.

Corrections must be carried out as follows:

The incorrect data is invalidated by scoring through it once - the original data must remain legible. The correct data is to be written next to, above, or below, the incorrect data together with initials, date and a brief explanation of the reasoning (see below). The reasoning may be left out if the correction is due to a spelling mistake.

8.50 G

8,520 G

Readout error,
>Date/Initials<

  • If data that has been initialled twice needs to be corrected, the change must be initialled twice.
  • The person who changes the incorrect entry is responsible for ensuring that the correction is faultless.
  • If copies of the relevant document have been made prior to the correction, the old copies must be replaced by new ones once the correction has been carried out and then destroyed.

2.6 Notation of date and time

The date notation must be clear. When using pre-printed forms/blank forms a clear assignment is advantageous.

For date notation the following format is required:

Day:

two digits
(e. g. 03.)

Month:

two digits or letters (e. g. 01. or Jan. or January)

Year:

2 or 4 digits
(e. g. 99 or 1999)

The time must be stated as follows:

Hours: two digits (e. g. 09:)

Minutes: two digits (e. g. 20)

2.7 Number notation

In handwritten documentation a comma is used for decimal numbers:

8,520

NOT: 8.520

   

2.8 Signatures

It is possible to clearly identify the person who carried out the relevant documentation by their signature and initials.

Signatures and initials in any organisational area must be unique and fully legible. Alternatively, a document must exist in which the signature and initials of each person are clearly assigned to their name.

Signatures are normally used for the compilation, analysis or approval of documents, and initials are used for individual items of data.

2.9 Invalidation of empty fields

Empty fields must be clearly invalidated - either by striking them through or entering "n/a".

2.10 Archiving

GMP-mandatory documents and data may not be disposed of or destroyed, they must be retained for a defined period. The periods that apply for each document type are described in the archiving guideline.

End of operating procedure

Distribution list for SOP

Title of operating procedure: GMP conforming documentation (QS-AD-017-03)
Binding for:

Production
Manufacturing operation 1
Manufacturing operation 2
Manufacturing operation 3
Central weighing area
Documentation
Quality control
Laboratory 1
Laboratory 2
Laboratory 3

Documentation
Formulation
Development laboratory 1
Development laboratory 2
Development laboratory 3
Development laboratory 4
Quality assurance
Management
Documentalist

For information to:

Central documentation

Receipt

I hereby confirm receipt of the operating procedure

"GMP conforming documentation (QS-AD-017-03)"

Date signature

Summary

A GMP conforming documentation makes it possible to trace the history of a batch and, should the need arise, may be used as evidence during court proceedings.

The following principle applies: "Nothing exists unless it has been documented."

Documents may also be compiled in a handwritten form provided that the information they contain is clear, legible and indelible.

Corrections must be accompanied by initials, date and reasoning.

GMP documents must be stored for at least one year beyond the expiration date of the products manufactured and also be available in this period (important in the case of electronic or optical archiving media).



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