Hello Anon,
Your question is a little hard to answer in one go without understanding type of device, processes existing, and what type of equipment or tools are being used in the manufacturing line. It is understood this includes a Class 8 cleanroom, but there are many aspects to be considered around new cleanrooms such as as rest, normal operations, and equipment running. Moving only one or numerous manufacturing lines also needs to be considered because is that one line representative of the other manufacturing? Does it affect the master validation plan? What equipment is being used? The questions being asked could not be solely answered because a regulatory authority reviewing the process may accept or not accept activities being done. Probably the most important aspect you could complete is having a clearly documented Quality Plan explaining what is happening, what is being moved, how its being moved, acceptance criteria, equipment, calibration, validation, re-validation, etc. There are a lot of aspects to consider that is beyond just thinking would what cause red flags with a regulatory authority.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Sep-2020 18:51
From: Anonymous Member
Subject: Relocation of manufacturing site + CEA
This message was posted by a user wishing to remain anonymous
We are moving our medical device manufacturing facility, which includes an ISO Class 8 cleanroom. It has been suggested that we move only one of numerous manufacturing lines and only that lines associated equipment, into the new CEA and complete the validation activities, with follow-up monitoring once all equipment and remaining manufacturing lines are moved. Do you think this approach will cause any red flags with regulatory authorities?