Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas

September 1, 2003
William Miele

Jean Huxsoll

Betty Seawell

BioPharm International, BioPharm International-09-01-2003, Volume 16, Issue 9

The complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.