ISO 9001:2000 vs. GCP - (Good Clinical Practice - environment)

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howste

Thaumaturge
Super Moderator
#3
Re: GCP and ISO 9001:2000

Google says: Good Clinical Practice?

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.
 
R

Rolf Siegel

#4
Re: Re: GCP and ISO 9001:2000

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 ...

Rolf
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
I know it's well 'after the fact', but has anyone here had any experience with GCP - Good Clinical Practice?
 
A

allen ml - 2007

#6
GCP vs. cGMP?

Marc said:
I know it's well 'after the fact', but has anyone here had any experience with GCP - Good Clinical Practice?
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.
I agree, it seemed to coincide pretty closely IMHO. That is...if cGMP and GCP end up being the same thing :confused:
 
Last edited by a moderator:
W

wrodnigg

#8
allen ml said:
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 :confused:
I know cGMP as Current Good Manufacturing Practices which is concerned with production of phamaceutics.

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.
 
G

GCPQA

#9
Rolf Siegel said:
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 ...

Rolf
I have a similar interest in the relationship between ICH GCPs and ISO 9001:2000. Have you received any useful feedback?
 
B

BertPeeters

#10
Hi,

Does someone have some experiences he/she wants to share on this topic? I would like to write a paper on this topic.

Thanks in advance,
 
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