K
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?
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?