This course will offer participants a comprehensive insight into USP requirements for microbiology and sterility assurance in the context of 3 USP General Chapters, Evaluation of Aseptic Processing Environments, Sterility Assurance, and Sterilization. The chapters covered are the following:
– <1116> Microbiological Evaluation of Aseptic Processing Environments
– <1211> Sterility Assurance
– <1229> Sterilization of Compendial Articles

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Explain the role of USP in Microbiology and Sterility Assurance of compendial articles.
– Describe and apply different sterilization methods.
– Explain aseptic monitoring of clean rooms, design and qualification of clean rooms.
– Develop an environmental monitoring program given USP standards.

Target Audience (If applicable):
– QA/QC staff
– Regulatory affairs managers
– Regulatory professionals
– Scientists
– Microbiologists
– Investigators
– Other professionals who work or interact in a pharmaceutical microbiology laboratory environment.