Considerations For Sterility Test Methods When Working With CDMOs
Miriam Guest at AstraZeneca, Anne Weeks at Merck KGaA and Chris Berridge at Ecolab
About this talk
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.
BioPharma Webinars aims to keep its global audience abreast of all developments in the areas of Drug Development, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality webinars, presented by the most respected people, working with companies in Pharmaceutical, Biopharmaceutical, Biologics and Biotech Industry.…