Over the past several years, the FDA has made a number of observations that some firms have not performed adequate testing of incoming APIs, components and raw materials. These regulatory requirements are defined in GMPs.
Due to recognized problems in the incoming material supply chains, the FDA is placing more emphasis on material quality. But, on the basis of the stated observations it appears that some organizations have misinterpreted or chosen to ignore the regulatory expectations.
One of the priority items in an FDA inspection is a review of how the organization handles out-of-specification (OOS) test results. This has resulted is a great number of observations reported in FDA 483s and Warning Letters. The Warning Letters demonstrate that organizations do an inadequate job in the investigation of OOS results and the corrective and preventive actions that should follow.
This 90-minute session by expert speaker Jerry Lanese will discuss the regulations within the GMPs that apply to the receipt and testing of APIs, excipients and other components of a pharmaceutical product. It will include reference to specific FDA observations and an analysis of what happened and actions to avoid similar observations and practical considerations in achieving compliance with FDA. Going further, it will also help the personnel in the quality control laboratory understand what the FDA expectations for incoming materials testing are, and the role of Quality Control in achieving compliance in the area of incoming material testing and release.
Who Should Attend
Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...
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