Sterility Testing of Pharma Products
The aim of Sterility Testing of Pharmaceutical Products is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future.
This book balances theoretical, and sometimes philosophical, discourses about the nature of sterility and the conceptual problems of microbial viability with sound practical guidance on how to validate the sterility test, problematic products as well as solutions on how to control the environment and review manufacturing process parameters, while navigating the regulatory minefield. PDA. 240 $.