Good Manufacturing Practices Implementation in a Manufacturing Facility

ScottK

Not out of the crisis
Staff member
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#11
thanks everyone for your inputs. :agree1:

i was wondering if anyone can give me some advice on this: :eek:

because the terms in the GMP standards are quite vague, such as; the personnel shall have sufficient training, and the manufacturer needs to ensure they receive the training, etc.

how do i determine the type and the level of training is sufficient to obtain the GMP certificate? is there like an industry best practice standards that everyone follows?

thanks again
:thanx:
In my past dealings with the US FDA they will review your documented process.
If the process is deemed effective then the training part just needs to be documented.
How do you show that you ensure effective training? Give a quiz after the training (and of course save the quiz as proof of training). FDA eats that up.
I used to do "General GMP Training" with a 10 question fill in the blank quiz at the end.

Best practice I've seen for GMP compliance has been Procter & Gamble "19 Key Elements". I attended a 5 day training class in that in 2000.
Don't know if they still used this or have developed a new program since.
 
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