Microbiological Examination of Nonsterile Products (Live Webcast)

Course Description:This course provides a comprehensive understanding of practices in the testing and control of bioburden/contamination of non-sterile drug substances and products in the pharmaceutical industry. It also gives an overview of the USP General Chapters that address microbiological attributes, testing procedures for bioburden control and tests for specified microorganisms (objectionable microorganisms), and bioburden control of nonsterile substances and products. USP-NF General Chapters include the following:

• USP <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia Cepacia Complex
• USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• USP <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
• USP <1112> Application of Water Activity Determinations to Non-Sterile Pharmaceutical Products
• USP <1115> Bioburden Control of Nonsterile Drug Substances and Products

Upon completion of this course, you will be able to:

• Explain the role of USP in non-sterile pharmaceutical products.
• Summarize the basics of growth-based compendial microbiology tests, including their variability.
• Explain the details of microbial examination of nonsterile products, enumeration and tests for specified microorganisms, objectionable organisms and recommendations on acceptance criteria for microbiological quality of non-sterile pharmaceutical products, and bioburden control of nonsterile drug substances and products.
• Explain the details of tests and acceptance criteria for microbial quality of non-sterile pharmaceutical products and bioburden control in nonsterile drug substances and products.

Who Should Participate:

• Microbiologists
• QA/QC staff
• Regulatory affairs managers
• Regulatory professionals
• Scientists
• Investigators
• Other professionals who work or interact in a pharmaceutical microbiology laboratory environment