Implementation of the New USP 61 and 62 - The Basis for USP Microbiological General Chapter Testing

In May 2009, the United States Pharmacopeia (USP), revision 32, implemented the long awaited separation of USP General Chapter <61> Microbial Limit Tests into two new chapters, i.e., USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration  and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.   Monographs for many non-sterile products reference this test, 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 antimicrobial effectiveness, environmental and utilities testing.

As part of these two new 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 objective of this live and interactive BenAstrum web training course is to explore the changes to this historic USP test method, compare it to the new 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 Micro-organisms, methodology and how it impacts the typical cGMP microbiological laboratory.

Discussion Points:

• Establishing microbiological analytical procedures based on process/product requirements
• Developing acceptance criteria for products, components and processes
• The long used historic method USP <61>
• The new USP methods – USP <61> and USP <62>
• Where the methods differ from the historic method to include changes in “Preparatory Testing”
• The harmonization of these methods with the comparable European Pharmacopoeia methods
• Alternative media used for the new USP <62>
• The use of phenotypic and genotypic methods for identification

Learning Benefits:

• Understanding the regulatory expectations for the new USP and harmonized EP
• Alternatives to using USP <62>
• Requirements for sampling
• Quantities of final product to test
• Media to use for testing
• Acceptance criteria meeting microbiological specifications
• Improving process reliability
• Improving product safety and reliability

Who Can Benefit:

Those who will benefit from this seminar include Quality Assurance, Quality Control and Validation professionals who are required to maintain Standard Operating Procedures consistent with the latest revisions of the USP and EP, as well as those that use contract manufacturing and contract testing facilities for their cGMP microbiological testing.

Please click here for the course agenda