I'm not familiar with GCP, but I recently reveiwed the proposed new FDA GMPs for dietary supplements. Pretty much all of the requirements were an excellent fit with an ISO 9001:2000 QMS.
I'm currently preparing a paper on this issue. So far, the "GCP - Good Clinical Practice - environment" is not very familiar with ISO 9001:2000 and the "ISO Speak". Therefore I thought it might be useful to put the GCP requirements against ISO.
it would make life easier if somebody already shares his/her experience ...
Would GCP be considered along the same lines as cGMP? (continuous Good Manufacturing Practice)
I don't know about other industries, but cGMP is a required compliance for our company (we produce plastic closures for the pharmaceutical/food industry), and compliance is mandated by several of our customers. Just recently we had a customer audit (3rd party) that included cGMP with its quality system eval.
howste said:
I'm not familiar with GCP, but I recently reveiwed the proposed new FDA GMPs for dietary supplements. Pretty much all of the requirements were an excellent fit with an ISO 9001:2000 QMS.
Would GCP be considered along the same lines as cGMP? (continuous Good Manufacturing Practice)
[...]
I agree, it seemed to coincide pretty closely IMHO. That is...if cGMP and GCP end up being the same thing
CGP means Good Clinical Practice and is something different:
It descripes how to design and conduct the performance, monitoring, auditing, recording, analysis, evaluation and reporting of clinical trials.
Also ethics are part of GCP, while they are not really part of GMP.
I'm currently preparing a paper on this issue. So far, the "GCP - Good Clinical Practice - environment" is not very familiar with ISO 9001:2000 and the "ISO Speak". Therefore I thought it might be useful to put the GCP requirements against ISO.
it would make life easier if somebody already shares his/her experience ...
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