Biotech/ pharmaceutical plant quality/operations imrovements
Biotech/ pharmaceutical plant quality/operations imrovements
(OP)
Hi
I have been given the task to improve the quality/operation in comliance with cGMP of a small biotech/pharmaceutical plant. Could anyone please help to find a guide/instructions to follow.
Thanks
I have been given the task to improve the quality/operation in comliance with cGMP of a small biotech/pharmaceutical plant. Could anyone please help to find a guide/instructions to follow.
Thanks





RE: Biotech/ pharmaceutical plant quality/operations imrovements
Firstly you need to gain an undstanding the intent of cGMP (and its associated GLP, GCP etc).
I would point you at websites for the FDA and PDA (Parental Drug Association). Then various magazines that are available.
The basic rule is that the FDA (and the other national bodies) assume that every one is a crook and if you can lie / forge something you will.