Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection)

F

Firststar

#1
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.
 
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somashekar

Staff member
Super Moderator
#2
Re: Medical Device Contract Manufacturing PAI

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.
Hi Firststar ... Welcome to the COVE
Is the medical device class I or class II
There is no need for anything like the PAI
Is it class III ? Then you will need it.
However you will need to be a registered establishment in the FDA data base, and keep it renewed annually. You can expect FDA to inspect you anytime upon a short notice. This will be based upon the QSR 21 CFR 810 and the QSIT (Quality System Inspection techniques) is followed by the FDA inspectors.
"doesn't really have a quality system in place" is an area of concern.
The implementation of the cGMP per 21 CFR 820 is your requirement. You could do this and as an assurance that you are good enough, you can at the same time work and be certified to the IS013485:2003 standard.
"CoB has inspected CoA and has a list of deficiencies that they would like CoA to fix." .. Do this first as this will certainly align with the 21 CFR 820 as well as the ISO13485 requirements.
 
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F

Firststar

#3
Thank you so very much for your insightful and speedy reply, Somashekar. I am so glad to have found the Cove. No man or woman is an island. I would appreciate some help on some follow-up questions.

CoA is small, under 50 employees total and they are hiring a QA Manager to help them address the observations from CoB and built their quality organization and quality systems from the ground up. But I would be doing it all by myself for a while. I could impress upon them that I may need consultants or contractor to help me along the way. There is so much to do. Just addressing the CoB observations or putting all the required quality manual and SOPsin place per 21 CFR 820 is a full time job alone.

It seems to me that being the head of quality (actually the whole QA organization), the position with this level of responsibility should be upgraded to Director. Does anyone know what the average pay for an Associate Director / Director in the medical device industry in the San Francisco Bay Area is? They are a privately owned company and doesn't have any stock options or restricted stocks that I am used to receive.

I am meeting with the VP of Operations next week to learn more about their operations and see what they have in place. Any suggestions as to what else I should look into during my initial visit to their facility?

Since I will the lone QA person on board initially, if I draft the quality manual and other quality documents, then I cannot approve it for QA. I guess I could draft the documents and have operations sign off as author, I can then sign off as QA. But I am used to seeing QA as author of quality documents. I would appreciate any suggestions as to the best way of handling this (that is acceptable to the FDA.

Many thanks for spreading the seed of knowledge globally.
 
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