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.
Couse Duration (hh:mm:ss): 04:24:24
Radha Tirumalai Ph.D.
Principal Scientific Liaison USP