AboutMichael Anisfeld Expertise 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
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question Hi Michael,
We make OTC products (e.g. antiperspirants, dandruff shampoos, zinc oxide, enema, oral laxative, cough lozenges) and need to know if freeze/thaw studies are necessary for any or all of these formulations? This has to do with shipping products from our whse to retailers via trucks where temperatures in some cases (25%) of the time may be at 32F or lower for periods of between 1-2 hours. Any thoughts from a regulatory point of view. Thanks.
Answer Dear Dexter:
I used to make these types of products, and we often had customer complaints due to product degradation due to the product having been frozen during warehousing and shipping. So from a purely business perspective, why would you not perform such studies?
Different countries have different requirements as to whether OTC products need to have stability studies. If the product is a drug, then yes from a regulatory perspective. If the product is a cosmetic (e.g. anti-perspirant), then for the EU yes, for the US not mandated.
By the way - think trucking in winter in Alaska, the Dakotas and Minnesota; these are locations where the trucking is much more than 1-2 hours. And while heated trucks are a possibility, availability is poor and expensive.
