In January of 2011, the FDA released its new guidance on Process Validation. This guidance is in line with ICH Q10 Pharmaceutical Quality System, which advocates a lifecycle approach to quality systems. As defined in the 2011 Process Validation Guidance, process validation involves a series of activities taking place over the lifecycle of the product and process:
Recently, a USP Expert published a Stimulus Article, Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification, which recommends a similar three-stage approach, and has identified Stage 3 as Procedure Performance Verification.
In both cases, the purpose of Stage 3 is to provide ongoing assurance that the process (a test method is a process) remains in a state of control. The concepts identified in Stage 3 apply to processes under development as well as processes that were developed and validated in the traditional way and are still in use. The European Medicine Agency has taken a slightly different approach and introduced the term Continuous Process Verification.
In this webcast, expert speaker Dr. Jerry Lanese, will discuss the lifecycle approach to process and test method validation. The discussion will include the differences between continuous process verification and continued process verification, but will focus on Stage 3 as described in the FDA Process Validation Guidance and the USP stimulus article. It will also offer insights on actions that an organization can take to recommendations found in the guidance documents.
The FDA is expecting pharmaceutical firms to have a lifecycle approach to all aspects of product and test method development and commercial production. The concepts identified in Stage 3 can be applied to old, existing products validated in the traditional way, as well as new products that have been brought to commercial production since the release of the process validation guidance.
Benefits of the Session:
The users will better understand:
Who should attend?
- Dr. David Lim
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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