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
Expert: Michael Anisfeld Date: 5/1/2008 Subject: Bulk product stability
Question We are using Hexagonal Corrugated boxes with double lined polybags with a desccant bag in between to ship Rapidmelt tablets. In such situation
1. What is the ideal packaging to study Bulk product stability?
2. While the study is in progress what is the suggested hold time prior to final packaging?
Answer Sorry, but I need clarification in order to answer.
The Hexagonal Corrugated Boxes - are they used to hold bulk tablets prior to packing in retail pack sizes (bottles or blisters); or is the packaging for the final retail pack fo tablets?
You are aware that FDA allows you up to 30 days bulk storage without the need to justify teh stability impact on product. Over this, you need to support your hold time with stability studies.
