FDA Guideline on Process Validation

FDA Guideline on Process Validation.

Process Validation (PV), as defined by the FDA, has undergone a change from the past 25 years or so. The meaning of PV is what the FDA assigns to it. So, any understanding of PV has to be tied to FDA’s guidelines which offer a definition of the term, as well as updates from time to time.

The previous and the latest guidelines…

The latest FDA guideline on PV came in 2011, and was consequential to the earlier one of 1987. In view of the changes in the industry, the definition of the scope of PV also changed. Earlier, the FDA described PV as the process of “…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 guideline of 2011

Considering the insufficiency of this definition, the FDA issued another guideline, an updated one, in January 2011 to make the definition more wide-ranging. Expectedly, it is more comprehensive and emphasizes process understanding and control as a means of focusing on product quality. PV now means “the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product”.

How is the 2011 Guideline different?

As defined more comprehensively in the January 2011 Guideline, the following changes may be discerned from the 1987 Guideline:

• There is added emphasis on process design. Risk is now incorporated into process design

• It now covers activities ranging over the entire process lifecycle, which is an ongoing program that is carried out in three defined stages

• Greater emphasis is laid on the role of objective measures and statistical tools

• Knowledge, detection and control of variability have got a greater thrust from this Guideline.

References:

http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf

http://www.ispeboston.org/files/handouts_-_morrison.pdf

http://www.pharmout.net/downloads/white_paper_fda_process_validation_guidance_final.pdf

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