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Pharmaceuticals/size of process validation Batches


Hi, Mike! We will be validating personal OTC products and the issue is that the requirement after the first 2 batches may not be as much as the first 2 validation batches. So if we validated the first 2 batches as 450 Gal in a 500 Gal. kettle. Can the 3rd validation batch be a smaller size say, 250 gal in the same tank?
Another option is to make a 90 Gal batch in a 100 gal kettle but then that is a different kettle and I believe we have to make more batches in this smaller kettle to consider it validated. Appreciate your response greatly !!!

As long as the equipment is identical, then go ahead and make the 3rd batch in the 250gal kettle; and issue a temporary validation report. When you make your next 400gal batch have this be the 3rd validation batch, and finalize your validation report.  


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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