Introduction

The GMP regulations from regulatory (FDA, EU or BPOM) all include mandatory section on
documentation. Documentation provides both :

a. Information on when, where, who, why and how to complete task.

b. Evidence proving that tasks have been completed as they should be.

Consequently, the standard of documentation can directly impact the level of success in
manufacturing quality product. That are safe as well success during audit situations.

Principle: Documentation is a part of management information system, and good documentation

constitutes an essential part of the quality assurance (CPOB,2012)

Objective

A reliable evidence for GMP compliance

To establish, monitor, and record “quality” for all aspects of the production, quality control and
quality assurance.

The basic of GDP

All documentation follows GDP, when it affects :

a) GMP processes.

b) Material or product identity, quality, purity, strength & safety.

c) The validated state of GMP product manufacture, facilities, equipment, computer systems
and testing methods.

What constitutes GDP ?

• Approve, review and update documents.

• Changes and current revision status of document identified.

• Relevant versions of applicable documents available at points of use.

• Documents remain legible and readily identifiable.

• Documents of external origin identified and their distribution controlled.

• Prevent unintended use of absolute documents, and archiving.

Documentation

Documentation may be divided into :

 Documents = procedural/instructional documentation.

 Records = evidence of compliance

 Both documents and records are an invaluable communication tool for any business.

Tiers of documentation

Broadly, all documents relating to quality fall into the following categories should be controlled:

Quality Manual

Quality Procedures

Supporting Documents or Work Instructions

Quality Records

Types of Documents & Records

Document and records used throughout the manufacturing process, as well as supporting processes
(e.g. QC or QA), must meet the basic requirements of GDP. These include :

o Batch Record Forms.

o Bill of Materials (BOMs).

o Specifications.

o Technical transfer reports.

o Protocols

o Standard Operating Procedures (SOPs).

o Work Instructions (WIs).

o Test Methods.

o Checklist.

o Forms/Log sheets.

o Training Assessments.

o Certificate of Analyses (CoA).

o Validation documentation.

o Electronic & hardcopy quality records.

Permanent records

Traceability of records in the GMP environment is of critical importance so that :

 o The company can prove they are compliant to the code of GMP and their own
processes and procedures.

o The root cause of a non-conformance or a justified costumer complaint can be

identified.

o Corrective or preventive actions can be implemented and their effectiveness

checked over time.

General requirements

No Requirement

1 Deliberately amending or destroying GMP records to hide or falsify data is fraud.

2 Do not discard a GMP record just because you might have made a mistake, it is still required for traceability.

3 It is not acceptable to discard GMP records for any reason unless the retention period expiry is reached.

Loose unofficial papers, notes and uncontrolled documents that can easily be lost or changed without
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appropriate approval do not meet GDP requirements.

Do not use notebooks/legal pads with easily removed pages, scrap paper or post-it-notes to
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record GMP information.

Record Control

GDP procedure should describe the types of workbooks, that may be used typically these are hard-
covered with sown/sturdy binding. Avoid spiral bound workbooks or logbooks as pages may be
removed.

Copy document

Sometimes there is a need to use a copy of an original document or record. So that it is apparent
that the record is not the original :

1. Stamp or write on the front of the copied documentation, “True Copy” or

“Controlled Copy”.

2. Sign and date the “True Copy” amendment.

Others requirements : Numbering system, Communication style, Data integrity