Quality Asssurance in an API Manufacturer

[KDail]

Hi Everyone! I'm a newbie here, have been a lurker and am DELIGHTED to have found the Cove - lots of great knowledge-sharing going on here!!

I changed jobs recently and now work for an API manufacturer (Active Pharmaceutical Ingredient). I was previously in an ISO 9001 manufacturing environment and an ISO 17025 analytical testing lab. In my new job I'm being told "ISO doesn't matter here, all that matters is GMP, your ISO CQA certification (which I just earned last June) is nice but not necessary...we're only concerned with GMP."

Is this because we do not manufacture the final drug product?

I haven't seen many threads here involving Pharma - maybe that's not the focus of the Cove?

 

[Ajit Basrur]

Hi Everyone! I'm a newbie here, have been a lurker and am DELIGHTED to have found the Cove - lots of great knowledge-sharing going on here!!

I changed jobs recently and now work for an API manufacturer (Active Pharmaceutical Ingredient). I was previously in an ISO 9001 manufacturing environment and an ISO 17025 analytical testing lab. In my new job I'm being told "ISO doesn't matter here, all that matters is GMP, your ISO CQA certification (which I just earned last June) is nice but not necessary...we're only concerned with GMP."

Is this because we do not manufacture the final drug product?

I haven't seen many threads here involving Pharma - maybe that's not the focus of the Cove?

Hello KDial,

We do have questions on Pharmaceuticals too in the Cove. Refer this section - http://elsmar.com/Forums/forumdisplay.php?f=179

On your question on acceptability of ISO certs in Pharma, its true that in the API industry, it is driven by 21 CFR Parts 210/211 and ICH Q7 requirements ... the ISO 9001 helps set a base for the QMS but may not address all the industry specific requirememnts as required by regulators like FDA and others.

You are free to post questions on API and Pharma in general and we would be delighted to answer