ABSTRACT
Microbiological testing is performed in all phases of a drug product manufacture-from testing of raw materials and sampling of the environment where production takes place to testing of in-process, nal drug product, and stability samples. Microbial testing also supports process and cleaning validation activities. All testing performed in support of both nished pharmaceutical products and active pharmaceutical ingredients (APIs) must comply with cGMP regulations as specied in the 21 CFR Parts 210 and 211, Subparts I (Laboratory Controls) and J (Records and Reports), and in FDA’s document Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7). These regulatory documents state that any out-of-specication (OOS) result obtained must be adequately investigated whether the material is acceptable for release or not. OOS data is dened as results that fall outside established product specications or test acceptance criteria.
