Good Documentation Practice in Pharmaceutical Industry (EudraLex Vol- 4)

Good Documentation Practice in Pharmaceutical Industry ( As Per EudraLex Vol- 4)


Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products.

The Quality Management System should include sufficient instructional detail to facilitate a common understanding of the requirements, in addition to providing for sufficient recording of the various processes and evaluation of any observations, so that ongoing application of the requirements may be demonstrated. There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of document. Suitable controls should be implemented to ensure the accuracy, integrity, availability and legibility of documents. Instruction documents should be free from errors and available in writing. The term ‘written’ means recorded, or documented on media from which data may be rendered in a human readable form.

Required GMP documentation (by type):

Site Master File: A document describing the GMP related activities of the manufacturer.

Instructions (directions, or requirements) type:

Specifications: Describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.

Manufacturing Formulae, Processing, Packaging and Testing Instructions: Provide detail all the starting materials, equipment and computerised systems (if any) to be used and specify all processing, packaging, sampling and testing instructions. Inprocess controls and process analytical technologies to be employed should be specified where relevant, together with acceptance criteria.

Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), give directions for performing certain operations.

Protocols: Give instructions for performing and recording certain discreet operations.

Technical Agreements: Are agreed between contract givers and acceptors for outsourced activities.

Record/Report type:

Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which is used to generate other records for electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data

Certificates of Analysis: Provide a summary of testing results on samples of products or materials together with the evaluation for compliance to a stated specification.

Reports: Document the conduct of particular exercises, projects or investigations, together with results, conclusions and recommendations.

Reference :-

Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Chapter 4: Documentation

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