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 testing and bioburden control of nonsterile substances and products. USP-NF General Chapters <51> Antimicrobial Effectiveness Testing, <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia Cepacia Complex, <61> , Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products, <1115> Bioburden Control of Nonsterile Drug Substances and Products, <1117> Microbiological Best Laboratory Practices, and <1227> Validation of Microbial Recovery from Pharmacopeial Articles will be covered. Additional topics on objectionable microorganisms and best lab practices in microbiology will also be covered.
Upon completion of this course, you will be able to:
- Explain the role of USP in microbiology and sterility assurance.
- Summarize the basics of growth-based compendial microbiology tests, including their variability.
- Explain the details of antimicrobial effectiveness tests, microbial examination of nonsterile products, enumeration and tests for absence of specified organisms, objectionable organisms and recommendations on acceptance criteria for microbial 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; Sterility Tests and Sterility Assurance; Bacterial Endotoxins Test; Bioburden Control in Nonsterile Drug Substances and Products; and Contamination Control and Monitoring in Aseptic Manufacturing Environments.
Who Should Participate:
- Regulatory professionals
- Regulatory affairs managers
- Scientists
- Investigators
- QA/QC staff
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment