cGMPs, Quality Requlations for Drug Manufacturer's & Their Suppliers

Douglas E. Purdy

Quite Involved in Discussions
#1
I have been writing systems (e.g., Mil-I-45208, Mil-Q-9858, ISO-9000, QS-9000, Guide 25 and ISO 17025) since 1990 but only recently began working with a supplier to a Pharmaceutical Manufacturer. The supplier procures instrumentation that is utilized in the drug manufacturing process. I would like to know if there are Quality Regulations for Pharmaceutical Manufacturers and their suppliers.

I have a general understanding of Title 21, the CFRs 210 and 211 for GMPs concerning Drug Manufacturers, and have come across Q7A - Good Manufacturing Practice for Active Pharmaceutical Ingredients (I) 9/25/01. But I do not know of Quality Regulations for Pharmaceutical Manufacturers and their suppliers. CFR 820 Quality Regulations are for Medical Device Manufacturers. What about the Pharmaceutical Manufacturers?

Any assistance would be GREATLY APPRECIATED!
 
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A

Aaron Lupo

#2
Douglas, If you mean is there a Standard for Pharmaceutical Manufacturers like there is for Medical Device manufactures (ISO 13485/88) after doing a quick serach I was unable to find anything.
 
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