Validation of environmental monitoring methods and levels.

Abstract

Environmental monitoring is an essential requirement in the pharmaceutical industry. Results which the manufacturer obtains from environmental monitoring must be reproducible and assure that the aseptic environment is under control. Today, more than ever, environmental data is scrutinized during FDA CGMP and preapproval NDA inspections and this trend will likely continue. Environmental test methods which have been in existence for years are accepted throughout the industry, but the user must bear the responsibility of proving that the methods yield reproducible results. New test methodologies must be validated to be as good as or better than the methods they are replacing. Currently, environmental result alert/action levels in existing facilities should be based on industry guidelines and facility performance validation. The pharmaceutical manufacturer must demonstrate that the levels which have been established for the facility have a statistical basis related to the historical performance of the facility. As time goes on, environmental levels may be readjusted to coincide with the operational performance levels of the facility.