Pharmaceuticals/Bulk Hold Time

Advertisement


Question
Can a bulk product hold time, which has been validated for a particular product, be applied to the same product if the API used has been supplied by a different manufacturer? It can be assumed that process validation has been completed on the product with respect to both API manufacturers.

Answer
Emma:

Great question.

In my opinion, and I have no regulatory guidance to back me up on this (and I doubt if their is official guidance anyway), if the second source API meets your exact API specifications (especially that there are no additional impurities, or different impurities hiding within the "other impurities" category, then scientifically I cannot see why you'd need to repeat the "bulk hold time" study.

Of course, as you have said, you have performed process validation studies using both API sources.

I hope this helps,

Pharmaceuticals

All Answers


Answers by Expert:


Ask Experts

Volunteer


Michael 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

©2016 About.com. All rights reserved.