Since the turn of the century, the FDA has promoted the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. Both guidances include elements of Process Performance and Product Quality Monitoring and Management Review which should be part of the Annual Product Review process. Product Reviews are also required by the EU and Canadian GMPs. A 2015 FDA guidance on Quality Metrics places additional emphasis on the Annual Product Review. The FDA will be focusing more on the content of the Annual Product Review and the involvement of senior management in the review and follow-up of the Annual Product Review.
In this webinar with expert speaker Jerry Lanese we will discuss the Annual Product Review (APR), or Annual Product Quality Review. The discussion will include the regulatory requirements found in the US EU and Canadian GMPs. It will itemize what should be covered in the APR and the use of risk analysis to identify the critical data. The emphasis will be on the defined purpose of the Annual Product Review – to identify areas for product and process improvement. The discussion will also point out that the recent US and EU guidances on process validation and the FDA Guidance on “Quality Metrics” bring new purpose and visibility to the Annual Product Review.
The FDA is emphasizing the Pharmaceutical Quality System, quality metrics, the involvement of management and continuous improvement. It is important that all levels of management and operations personnel understand this FDA focus and the impact on the Product Review.
Key areas of discussion will include:
The Annual Product Review has been a requirement since the implementation of the US GMPs in 1979. It is one of the best tools for proactively identifying areas for the improvement of the product and process. However, most companies have done a relatively superficial job in the preparation and follow-up of the APR. The publication of a new process validation guidance by the FDA in 2011, a revised chapter on process validation in the EU in 2015 and the FDA guidance on “Quality Metrics” place more focus on the Annual Product Review. Pharmaceutical firms should be looking for ways to make the Annual Product an effective component of the Quality System focusing on management review and process performance monitoring and continuous improvement.
Who Should Attend
The following individuals should attend this audio seminar:
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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