What Microbial Tests Should be Considered Stability Test Parameters?

Introduction:

In the absence of definitive guidance on microbial testing in R&D and Marketed Product Stability Programs for Drug Substances and Drug Products, the pharmaceutical industry makes inconsistent and sometimes misguided choices with respect to microbiology. These choices are further confounded by the fact that stability programs are almost always managed by analytical chemists or pharmacists without training and limited experience in the field of microbiology.

This article will review the current regulatory guidance and provide recommendations on the role of microbial testing as stability test parameters, and when other physicochemical tests will be preferred to microbiological tests. To be comprehensive, a product life cycle approach will be taken for drug substances and both sterile and non-sterile drug products.

Methods • Parameters • Protocols • Study Design • Testing