What size of batch should be studied under process optimisation during process qualification in pharmaceutical industry?
Dear Rishabh,
To my knowledge, it is about 10% of the production-scale batch.
For more information, you may use the following link:
http://www.pharmtech.com/strategic-approaches-process-optimization-and-scale
Rafik
Dear Rishabh,
Generally 1/8th or 1/10th of the commercial batch size is used for process optimisation. However it also differs from country to country because you may have to follow the local drug authority guidelines apart from the ICH. However, the best to go is 1/10th of the commercial batch size.
Regards,
Abhishek
As per FDA:
For Solid Dosage:Two Pilot Scale batches of 100,000 units or at least 10% of proposed production whichever is greater, Third batch can be smaller than 10% of proposed production but NLT 25% of the pilot scale
For Parenteral: Two batches at least 10% of proposed commercial size (i.e. pilot scale size) or 50 L whichever is larger. Third batch can be smaller than 10% of proposed production but NLT 25% of the pilot scale
All submission batches manufactured under CGMP with same formulation, same specifications, and at the commercial site
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