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Release of the first batch of a cleared product before process validation

#1
I'm wondering if anyone can point me to anything in the regulations that would allow for release of the first batch of a cleared product prior to all process validations are complete. Complete verification cannot be achieved.
 
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planB

Trusted Information Resource
#2
Could you please clarify several items in your post:

"cleared" product: what do you mean by this term? A product produced at nominal parameters of all to-be-validated processes? Or a product that has undergone some final inspection / clearance?

"Complete verification cannot be achieved.": Do you imply by this statement that you actually have to achieve 100% verification? And are your process acceptance criteria actually verifiable during operation?

Some general notions: releasing a batch on its own merits after processes that require validation, is principally possible, but you would have to validate the process on the affected batch, which involves some extra work on this batch. There is some specific guidance around in the field of sterilization:

- ISO 11135:2014/Amd1:2018, Annex E, Single Batch release, terminal EO sterilization
- ISO 11137-2:2013, section 9.3, Procedure vor VDmax25 for a single production batch, terminal irradiation sterilization

HTH,

Gerhard
 
#3
Hi Gerhard,

Thanks for your reply. I'll happily give you some more information on this specific situation.

By cleared product I mean that it is FDA cleared, but currently only IQ and some OQ and PQs have been completed. In process and final release testing are being planned.

Any verification testing would be destructive and therefore we may not be able to "fully verify." We had tossed around the idea of performing verification for those processes which will not have validation complete.

Very interesting about batch release I will look into that further.

Please let me know if you have any other thoughts.
 

yodon

Staff member
Super Moderator
#4
I've seen that it's not uncommon to quarantine the outputs from a PQ until you have completed the PQ / assessment. If the validation is successful, the material is taken out of quarantine and put into distribution.
 

planB

Trusted Information Resource
#5
Quality Shmality,

adding to yodon: I think quarantining your product until you have completed your process validations, that you have defined to be critical to your product quality, is the closest you can get on the way to distribution.

HTH,

Gerhard
 
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