USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products

The United States Pharmacopeia (USP), revision 32, implemented separation of USP General Chapter <61> Microbial Limit Tests into two chapters, i.e., USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration, and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, in 2009.

As part of these two chapters, USP <61> and USP <62>, changes were made within the areas of sampling, quantities of final product required for testing and the media to be used for this testing. In addition, acceptance criteria have changed when recording acceptable microbiological results.

The monographs for non-sterile products reference these tests, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing.

Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the USP pharmacopeial method, will also be examined as part of USP <61>/<62> and examples provided.

The objective of this live, interactive webinar is to explore the changes to this historic USP test method, compare it to the European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

Learning Benefits

• Understanding the regulatory expectations for the USP <61>/<62> and harmonized EP.
• Alternatives to using USP <62>.
• Requirements for sampling.
• Media to use for testing.
• Acceptance criteria required to meet microbiological specifications.
• Improving process reliability, product safety and reliability.
• Examine how case studies may provide improvement suggestions within your organization.

Who Should Attend

The following individuals or disciplines will benefit from attending this webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development
• Regulatory Affairs Professionals
• Validation
• Auditors