Good Documentation Practices in Regulated Environments

August 20, 2020

“Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you did a poor job no matter what you really did.”Marco Polisena

Introduction

Good Documentation Practices (GDP) has evolved to be one of the essential Good Practices in regulated environments such as pharmaceuticals manufacturing for many years now. Having developed from predicate rules for record-keeping in quality system management, as well as 21CFR 11 for electronic records and electronic signatures, GDP has evolved to become a quintessential tool for documents industry. “In any regulated industry, documentation can provide evidence of conformance with regulatory authorities’ expectations. As with all complex operations, the completeness and accuracy of the documentation content is paramount in maintaining daily work in compliance” [1]

It is required for documentation concerning Good Laboratory Practice, Good Manufacturing Practice, and Good Clinical Practice, and usually is relevant throughout the entire lifecycle of a product.

However, companies still receive warning letters from the FDA solely for not following the required documentation practices. Ideally, this should not happen, since GDP is vital for every single step of a product’s manufacturing stages and all that evolve around it.

This blog article was written with the intention that companies who are still in need of improvement with the matter of GDP compliance could gain perspective and learn to mitigate possible future compliance problems accordingly.

What is GDP? – A definition

In Quality Control Training Manual, Comprehensive Training Guide for API, finished Pharmaceutical and Biotechnologies Laboratories, documentation is defined as “a system which manages and controls all documents during various activities performed in a pharmaceutical organization.” [2]

A common misconception about GDP is that it stands for Good Distribution Practice only, which is untrue, and of course, can be confusing. The acronym stands for Good Distribution Practice and Good Documentation Practice. It is the responsibility of all workers in a project or operations to define the acronym for clarity and to avoid confusion.

The purpose of GDP is to capture all actions that take place, in various stages of a product, from development to implementation, on to testing and release to ensure patient safety, product quality, and data integrity. Whether lifecycle documentation, project or operational documentation are concerned, GDP ensures that all information is accurate and is legible and understandable to all reviewers (no errors allowed!) and traceable (what change was made to a document, who made it, and when).

Over the past few years, FDA warning letter documented the failure of adequate compliance of good documentation practice. Therefore, if, at any point of the process, an action is not documented, this could very possibly result in regulatory action. Think of GDP as the following: The recording of data, approving of documents, issuance and disposal of documents, ability to retrieve, review or disposing of documents. When not implemented correctly, it can have an impact on many parts of drug production. For example, a missing training record that proves an associate has had enough education can result in a warning letter 483, rendering the entire batch invalidated. Or even more simple: If an empty space on a record is left blank, instead of being marked with N/A, it is considered an incomplete record. This is also a reason the FDA would issue a warning letter, making all other efforts to prove the process is still compliant much harder, expensive and time-consuming than if the responsible person had followed the instruction for GDP and handled the document the correct way.

Sources

[1] Singer, Donald C; A Laboratory Quality Handbook of Best Practices and Relevant Regulations. Milwaukee, ASQ Quality Press Publications, 2001.Print

[2] Imtyaz Hayder, Syed and Syed Asif, Erfan. Quality Control Training Manual, Comprehensive Training Guide for API, finished Pharmaceutical and Biotechnologies Laboratories. Boca Raton, CRS Press, 2011. Print

Author: Marco Polisena, Life Science Consultant KVALITO. 

KVALITO is a strategic partner and global quality and compliance services and network for regulated industries. To learn more about our services, please visit us on www.kvalito.ch

If you would like to benefit from KVALITO’s expert services, feel free to send us an email to contact@kvalito.ch.

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