What is the difference between a registration batch and a validation batch?
The product is manufactured under GMP conditions for definitive stability and bioavailability studies. The manufacturing scale of these lots should meet the minimum requirement of 1:10 scale of the proposed commercial scale. The registration lots should be manufactured using processes and equipment representative of the full scale. The FDA requirement includes manufacturing at least one registration lot using the actual equipment and at the manufacturing site. The number of required registration lots is determined based on 1) the manufacturing site(s) of the bulk drug substance, 2) the number of dosage strengths, and 3) the manufacturing site(s) for the final drug product.
Generally, process validation is carried out in the commercial batches manufactured.
Can registration batches be also used as the validation batches?
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