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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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How-to Apply Quality by Design (QbD) Principles to Process Validation

April 17, 2014 by
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What does QbD mean for pharmaceutical companies? Quality by Design (QbD) refers to a set of risk-based principles, applied to manufacturing practices in order to ensure that the development and processes yield a quality product based on solid scientific and engineering principles. For pharmaceutical companies specifically QbD principles are based on regulations that have been around for several years (since 2006), such as ICH Q8 Pharmaceutical Development and ICH Q9 for Quality Risk Management and Q10 for Quality Systems. Thus, a majority of the QbD components for process validation are not unfamiliar. When helping to incorporate the QbD principles into our clients’ process validation practices, we notice that a lot of the pieces are already in place. It’s usually more about organization of data consumption by all stakeholders. It then becomes a question of how to make the right data, available to the right people, for the right purpose, and how to automate these hand-offs so that the entire lifecycle becomes more systematic. ‘ Where is QbD Applicable? QbD principles are applicable to the design stages of your product and manufacturing process, and where you perform verifications of the final design. These phases together are commonly referred to as “Design of Experiment” (DOE), or “Design Space.” According to the new guidelines for process validation, QbD has the greatest presence during…


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