Managing Environmental Monitoring Excursions
November 2016 - Vol. 13 No. 11 - Page #20

Significant pressure is being placed on hospital pharmacies to ensure compliant compounding operations in the face of increasing scrutiny from government regulators, state boards of pharmacy, and health care accrediting agencies. As these bodies are focusing on the gamut of pharmaceutical compounding, there is an expectation that pharmacies are operating at USP <797> standards, and in some cases, current Good Manufacturing Practices (cGMPs) as well. Integral to maintaining the standards set forth by both USP <797> and cGMPs is a comprehensive and robust environmental monitoring (EM) program.

Part 1 of this feature—Impact of USP <797> on Environmental Monitoring—delves into the structure and implementation of a proper program, as well as the regulatory divergence of USP <797> and cGMPs. Presented here, part 2 discusses the inevitable excursions that will take place within a sterile compounding environment and how best to manage them.

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