Considerations For Sterility Test Methods When Working With CDMOs

The confirmation of microbial quality of drug products manufactured by contract manufacturing organisations (CMOs) is a key component of product release.  Whilst the responsibility for product release may lie with the CMOs quality organisation, the sponsor is required to ensure the appropriate quality of the article.  Compendial methods for microbial enumeration and sterility are provided in the harmonised pharmacopeia’s (USP, Ph Eur, JP1,2,3), however within the framework of the  compendial chapters, there are a variety of approaches which can be made to meet the requirements. Whilst compendial methods provide a starting point to define a product specific method, the presence of the test article can lead to interference with the proliferation and detectability of microorganisms.  It is essential the product specific method is demonstrated to be suitable in the laboratory that is conducting the routine testing. During this webinar you’ll hear an overview of the different approaches to meeting the compendial requirements for the tests for sterility and microbial enumeration.