FDA publishes Final of new Process Validation Guidance

In November 2008 the FDA published a draft to revise their old Guideline on Process Validation from 1987. The ECA analysed this draft (see GMP News from 26 November 2008) in details and evaluated a detailed survey about the content of this draft (see GMP News from 11 March 2009). The result of this survey was also sent to the FDA as a comment.

Now, on 25 January 2011 the FDA puplished the final version. What are the differences to the draft?

In summary, it is conspicuous that there are no big changes in the final version compared to the draft from November 2008. However, already slight differences could influence current industry practices. Nevertheless, there are some remarkable changes:

  • The whole document, for instance, is focusing more on a risk-based approach than the draft version.
  • Further, process improvement is emphasised - for legacy products as well.
  • The terms attribute(s) and parameter(s) are not categorised with respect to their criticality in this guidance.
  • There is a clarification of viral and impurity clearance studies.
  • The term Process Performance Qualification substitutes the old term Process Qualification. 
  • Regarding the Design of Facility and Qualification of Utilities and Equipment the term qualification is explicitly mentioned.
  • Sampling and monitoring in the Stage 2 is also emphasised.
  • The term drifts is changed to the terms unintended process variability  and undesirable process variation.
  • There are a lot of supplements regarding concurrent release of PPQ batches. Tenor: Use concurrent release only in special circumstances.
  • More flexibility due to validation documentation (degree and type) is mentioned.
  • There is a Clarification of the use of new analytical methods and regarding clinical studies.
  • A lot of ASTM Guides are referenced.

For detailed information please see the final guidance. A comprehensive analysis of the final guidance will be published on this webpage next week

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

PS: In the members area you find a comparision between the draft and the final guidance.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.