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Pharmaceuticals/about stability study

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Question
if i change only packaging condition(Sealing temperature)then is it required to redo stability study(three batches)or single batch is sufficient at long term storage condition?

Please give guideline reference if any.

Answer
If there are no changes in the packaging material, just a change to the sealing conditions (temperature - pressure - dwell time, then all you need to do is perform a qualification of the sealing step to demonstrate that the new sealing conditions still provide a tight seal that lasts the claimed shelf life of the product.

other than that, no stability study is required.

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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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