Foundations of Good Documentation Practices for GMP

Foundations of Good Documentation Practices for GMP

Good Documentation Practices (GDP), although indispensable for GMP practices; often gets overlooked. In relation to CAPA, validation, investigation and such other practices; GDP seems to be getting the scantest attention. Important though these programs are; none of them is complete without GDP or is a substitute for it.

The golden rule of documentation

The golden rule, or what may be said to constitute the very foundation of GDP, is this FDA dictum: “If it isn’t written, it didn’t happen”. Regulatory professionals could change it to:  “If it isn’t written clearly, it didn’t happen either”. It is not just writing down; it is how we write down what we write down too, that matters as much. This should serve as the basis for understanding the nature and importance of GDP. Look at the use of the word “clearly”. When your documentation is not clear about what it says; it is as good as non-existent.

Calls for documentation in several places

21 CFR Part 211 of the FDA is perhaps the best guide to documentation. Its various sections talk about the need for good documentation. Sub Section 211.100, Subpart F, which talks about Production and Process Controls, uses the words, “shall be documented”. Sub-Section 111 follows it up with “…shall be justified and documented”. In other words, justification for anydocumentation must precede the documentation.

21 CFR Part 211’s other sections, namely 211:100, 111, 130, 160, 165, 184 and 188 –all these are equally clear about GDP requirements.

So, if despite so many mentions, we are unable to implement GDPs; how is the FDA to blame!

 

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