Artur,
I would tend to agree with Richard on this. My inclination is always to ensure that the site is capable of handling the production process and all of the things that I would have expectations for them to perform for my company before doing any sort of tech transfer process. Couple of basic reasons for this:
1. If they can't do what I expect them to be capable of performing then there is no real reason to even discuss the technical transfer of production to the CMO.
2. Once you get to the tech transfer stage you are essentially providing valuable IP to a third party who might not even meet you most basic requirements for controls being in place.
3. Remember this is a supplier (regardless of what they are supplying) so you need to put them through the supplier qualification process (whatever your company determines that process to be) in order to qualify them to provide you with materials so if they fail to meet your standards, you have now wasted significant time in getting contracts in place, Non-disclosure agreements fully executed, etc. and you have to start over anyway with another supplier.
That is not to say that there should not be a significant period of checks and audits at a more intensive frequency for a new supplier even after they pass your qualification. You still need to define exactly what that strategy would look like. And I would also strongly consider whether or not the new supplier should be more heavily monitored especially during V&V and tech transfer to ensure that they are not only capable of meeting your "process" requirements (e.g. supplier qualification) but also that they can consistently meet your "quality" requirements in terms of production of whatever you plan to purchase (whether that is a portion of an assembly or the entire finished product).
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 24-Jan-2020 06:30
From: Richard Vincins
Subject: site qualification or tech transfer first?
Artur,
In my opinion definitely CMO site qualification first. There should be a standardised process defined within your supplier management activities which one of the first activities would be site qualification. I would also even suggest prior to site qualification there is a vendor questionnaire or survey to ask specific questions about operations, controls, and QMS process. Once the site has been qualified, again my opinion, tech transfer would be one of the last steps in the process.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 23-Jan-2020 11:16
From: Artur Shchukin
Subject: site qualification or tech transfer first?
Hello,
What are your thoughts on whether to perform CMO site qualification or tech transfer first?
Thank you for your time.
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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
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