This course offers participants a comprehensive insight into USP requirements for microbiology and sterility assurance. Additionally, it provides guidelines for monitoring and testing bioburden, including recommended limits, and best laboratory practices in microbiology. The following USP General Chapters are covered: <51>, <61>, <62>, <71>, <1111>, <1211> , <1115>, <1119>, <1119.1>, <1227>, and <1229>.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Describe the role of USP in microbiology and sterility assurance.
– Explain the types of microbiology tests in the USP–NF.
– Identify the basics of growth-based compendial microbiology tests, including their variability.
– Describe the details of antimicrobial effectiveness tests, tests and acceptance criteria for microbial quality of non-sterile pharmaceutical products, bioburden monitoring and objectionable organisms, sterility tests, sterilization, and sterility assurance.
– Explain the use of different microbial enumeration methods for bioburden testing.
– Identify bioburden testing procedures and associated tests, such as the Growth Promotion Test. 
– Describe best lab practices in microbiology.
– Participate in the USP standards-setting process.

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