This course establishes an understanding of microbiological best practices, classical (culture-based) and alternative, their advantages and disadvantages and their validation in the pharmaceutical industry. It also provides an overview of compendial and regulatory guidance on alternative/rapid microbiological testing.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Describe the role of USP in microbiology.
– List types of microbiology tests in the current USP–NF.
– Describe approaches to microbial detection, enumeration, and identification.
– Explain alternative growth and non-growth-based methods.
– Implement microbiological best laboratory practices.

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