Author Topic: Stability testing of process qualification/validation batches  (Read 1065 times)

Oddveig

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Stability testing of process qualification/validation batches
« on: October 18, 2012, 01:40:01 PM »
Do regulatory authorities expect to see full stability testing of all process validation/qualification batches?

Durga Prasad

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Re: Stability testing of process qualification/validation batches
« Reply #1 on: November 24, 2012, 10:46:12 AM »
Absolutely. They look keen into all details of batch, with out that validation is not fully satisfied.
The result of validation is a Quality and Stable product for a required period of stability in certain set conditions of manufacturing, packing, testing and release and proving its self life by precise test conditions and methods.
No short cuts. This is especially in case of Stage-3 FDA Process validation where modifications and change controls are particularly monitored and tested for their intended results with out compromising critical quality attributes of the final Drug Product.

 


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