Process Analytical Technologies (PAT)

MEI’s methods and approaches, are consistent with the FDA’s new Process Analytical Technologies (PAT) initiative. The initiative is to facilitate the introduction of new manufacturing technologies in the pharmaceutical industry for achieving more efficient processes. Process Analytical Technologies are defined as “systems that enhance process understanding and assist in identifying and controlling critical process points”. These include appropriate measurement devices, that can be placed at/in- or on-line, statistical and information technology tools, and a scientific systems approach for data analysis to control processes to ensure production of in-process materials and final products of desired quality.

The guidance document for the pharmaceutical industry places a strong emphasis on the maintenance of a high-quality environment. Various methods are suggested for monitoring the microbiological quality of the environment, such as surface monitoring, active air monitoring, passive air monitoring (settling plates).

Characterization of recovered microorganisms is noted as providing vital information for the environmental monitoring program. Although appropriate biochemical and phenotypic methods can be used for the routine identification of isolates, PAT further states that “Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. These methods are especially valuable for investigations into failures (e.g., sterility test; media fill contamination).”

http://www.fda.gov/cder/gmp/patprogressreport.htm
http://www.fda.gov/cder/OPS/PAT.htm