Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
Guideline (SOP) for quantitative enumeration of mesophilic bacteria & fungi that may grow under aerobic conditions and for detecting the presence of specified microorganisms in pharmaceutical raw materials and finished…
Procedure & Guideline (SOP) for Microbiological Analysis of Raw Material (API & Excipient), In process sample and Finished drug product in pharmaceuticals. Microbiological Analysis of Drug Product / Material 1.0 …