F
Firststar
Hello,
New to the site and would appreciate your thoughts on the following subject. Based on my experience, biotech and pharmaceutical contract manufacturers must pass a PAI (Pre-approval inspection) from the FDA or EMEA before they are allowed to make a new drug at their facility.
Does this also apply to Medical Device Contract Manufacturers? This subject came up during a phone interview. Company A(CoA) has a new contract with a medical device manufacturer, Company B (CoB) to make the device for them. This is the first medical device contract for CoA. CoA has never made any medical device before and doesn't really have a quality system in place. CoB has inspected CoA and has a list of deficiencies that they would like CoA to fix. CoA said that CoB told them CoA does not need pre-approval inspection from the FDA before they start making the medical device for them (CoB).
Are there different regulatory requirements on PAI between the biotech / pharmaceutical industry and the medical device industry? It makes sense to me that medical device contract manufacturer's should be required to pass a PAI in the same manner that biotech / pharmaceutical contract are required to do.
Thank you for your insights.
New to the site and would appreciate your thoughts on the following subject. Based on my experience, biotech and pharmaceutical contract manufacturers must pass a PAI (Pre-approval inspection) from the FDA or EMEA before they are allowed to make a new drug at their facility.
Does this also apply to Medical Device Contract Manufacturers? This subject came up during a phone interview. Company A(CoA) has a new contract with a medical device manufacturer, Company B (CoB) to make the device for them. This is the first medical device contract for CoA. CoA has never made any medical device before and doesn't really have a quality system in place. CoB has inspected CoA and has a list of deficiencies that they would like CoA to fix. CoA said that CoB told them CoA does not need pre-approval inspection from the FDA before they start making the medical device for them (CoB).
Are there different regulatory requirements on PAI between the biotech / pharmaceutical industry and the medical device industry? It makes sense to me that medical device contract manufacturer's should be required to pass a PAI in the same manner that biotech / pharmaceutical contract are required to do.
Thank you for your insights.