In the GMP World Good Documentation Is a Must
The overall purpose of documentation is to ensure patient safety. This is done by
- providing sufficient instructions to the manufacturing personnel
- keeping records of what has been done.
Documentation should, as appropriate, provide information on:
- when, where, who, why and how should a task be completed
- whether the tasks were actually completed as they should be.
Poor or incorrect documentation is a risk to patient safety!
Therefore the authorities, e.g. FDA and EMA have enforced regulations on GPD.
Qualification and validation documentation must fulfil GDP.
In the following sections, we will go through the authorities' and FVT's general expectations on documentation.
Why is good documentation so important?
- Because the authorities say that it is
- Because poor or incorrect documentation is a risk to patient safety
- Because it is a general expectation