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Pharmaceuticals/Bulk holding time

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Question
Hi M. Anisfeld,
If i have a bulk holding time of 6 months based on Pharmascience site of production and I want to do a site change of manufacturing,could I accepte the same 6 months for my new site or I must to do a new bulk holding time stability study? Please, if possible, give me the reference.
Thank you in advance,
Amir

Answer
If the bulk hold in the new site is in the same bulk container/closure system for the same product as previously evaluated; then I see no logic/value in a repeat of the bulk hold time; nor do I think that US-FDA regulations require it (check for requirements in other countries).

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Michael Anisfeld

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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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