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Pharmaceuticals/Finished product stability study

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Question
Hi M. Anisfeld,
Do we need to do (mandatory) thermal cycling and Short-term temperature excursion study on all pharmaceutical dosage forms(tablets, suppositories, syrup, ophthalmic, etc.?
Thank you in advance
Amir Naderi

Answer
Amir:

I am not super familiar with Canadian GMPs which might have specific requirements (in fact check the chart on stability studies that is an annex to the Canadian GMPs), but in general terms if the product is stored frozen or cold, then you need to perform thermal cycling studies.

I hope this helps.

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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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