Wednesday, September 30, 2015
I recently read with great interest that ICH has embarked on some very
significant changes in structure and organization1. While change based upon
historical experience can improve effectiveness; some changes sometimes
undermine effective ...
Monday, December 01, 2014
What is going on here? Why are so many problems being encountered by so many Active Pharmaceutical Ingredient (API) manufacturers, especially from India and China? Has the entire industry decided to ignore the rules of the game? Well, here is one man...
Active Pharmaceutical Ingredient manufacturers have faced
their share of regulatory concerns over the years. In fact, the
adoption of the ICH Q7A API GMP Guidance would have never occurred
if not for the absence of an accepted API GMP globally. In...
Wednesday, September 01, 2010
After 45 years in the drug and API industry, I have seen and experienced many things both as a member of the FDA’s regulated industries and as an active participant and I trust, contributor to the development of policies and practices used to ...
Saturday, January 01, 2011
What, in your opinion, is currently
the single largest trend with respect
to active pharmaceutical ingredients
outsourcing and manufacture?
Sunday, November 01, 2009
Change is inevitable whether intentional or unplanned. Some people like to write the “C” in CGMP as a small “c” to reflect the fact that “current” really represents a changing set of rules. Such changes can occur in an industry because of shifting ...