GMP-compliant documentation sucks
GMP-compliant Documentation is annoying, but it has to be done. GMP-compliant documentation is always prerequisite to be able to prove GMP-compliant production and technology. to be able to. What do I have to pay attention to? There are a few simple rules there are a few simple rules. In the GMP environment, documentation must always be unambiguous be clear, comprehensible, accurate, complete and timely. or take place.
Handwritten documentation must always be dated and signed. date and signature, whereby this is only possible with "document-proof" writing possible. That means with ballpoint pen it is allowed to improve, with pencil or ink, however, not. If there are empty fields, they must be these must be must be invalidated, i.e. crossed out. Such corrections and deletions must remain legible and it must always be possible to who made the correction and for what reason
How do I justify the correction?
Permissible justifications and their abbreviations are e.g.:
SF for spelling mistake
FE for wrong entry
RF for calculation error and
NA for not applicable
Attention. The rules can be different be. How exactly it is regulated depends mostly on the company itself! So take a look at your SOP (Standard Operating Procedure) first!
Is quite simple, isn't it? Then test yourself.
Click on the fields in this form.
If you still have difficulties with the GMP-compliant documentation, please feel free to contact us or send us your request. your request.
