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FDA Guidelines for Process Validation: Then and Now

September 17, 2015 by
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Difference between the 1987 and 2011 FDA Guidelines for Process Validation – an overview It’s been over 20 years since the guidelines for process validation were updated. The FDA’s 1987 guidance document, Guideline on General Principles of Process Validation was replaced January of 2011 when the FDA published the updated  Guidance for Industry-Process Validation: General Principles and Practices. The new guidelines introduces new concepts and principles and denotes the evolution in process validation requirements. Like other guidelines, they are not law, but adherence to them provides a good framework for building a compliance program. What Changed? The 1987 definition of process validation defined process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics”. The new guidelines defines process validation as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products”. From comparison of the definitions we can clearly see that the new guidelines are asking for a lifecycle approach for process validation as it requires collection and evaluation of data from the process design stage throughout production.  In the past, process validation activities commenced at product commercialization, and involved collection of massive amount of…


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ISPE/PQRI Process Validation Conference

September 11, 2015 by
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Comply with the FDA PV 2011 Guidelines and get your products to market faster with Validation Automation. Date: Oct 7th Time: 6-8pm (beverages included) Description: This discussion with experienced Pharmaceutical professionals will simplify, strengthen, and complete your knowledge of implementing, as well as automating the requirements set forth in the new FDA’s Guidance on Process Validation. During the presentation, you will hear firsthand from industry leaders on the approach and related experiences transitioning from historical Process Validation strategies to meet the new 2011 guidelines. Walk away with practical solutions and be equipped with the right information and tools to plot your company’s path towards a successful implementation of current validation principles and technologies. See ground-breaking innovations happening inside brand name pharmaceutical companies that can shorten production schedules and keep your team well ahead of Process Validation 2011 Guidelines. Outline for Event: Introduction PV Guidance: Business Drivers Key Elements Risk Assessment- methodology Statistical Analysis Tools- examples/case study Continued Process Verification- rules and steps Knowledge Management across Stage 1, 2, 3 Challenges/Implications of bespoke process, disconnected tools Application of PV Validator to realize above goals- CA Demo Target Audience: This event is ideal for personnel in product/process development, manufacturing, validation, QA, and QC involved in process validation and process control. Audience members will walk out with the following three actions/items to consider as…


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