Environmental Monitoring (EM) program requirements are currently described in the 21 Code of Federal Regulation (CFR) 211.42, 21 CFR 211.46, 21 CFR 211.22,1 USP <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments,2 European Medicine Agency (EMEA) Annex I3 , International Standard Organization (ISO) 14644-1,4 ISO 13408,5 ISO14698-16 and Parenteral Drug Association (PDA) Technical Report #13, Fundamental of an Environmental Monitoring Program (Revised, 2014).7 Regulatory agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) requires pharmaceutical manufacturing companies to have an EM program and standard operating procedures (SOPs) in place as an important part of the drug manufacturing control process to ensure product safety attributes. Regulatory bodies have established the requirement for trending and identifying contamination sources. Major observations have specifically been issued to companies that lack adequate systems for monitoring environmental conditions in aseptic processing areas and for not having written procedures for EM including sampling frequency, sampling locations and procedures for alert and action levels.

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• Cleanroom

• Monitoring Systems

• Biological Activity

• Contaminants

• American Pharmaceutical Review

• 4/1/2018

• Abstract