Revision to EudraLex Volume 4 August 2014

EU

Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.

Of note is the increased guidance around the use of quality risk management principles.

The revision will come into affect in March 2015.

What do you think of these changes? How will you adjust your quality program, if at all?

Like this MWV (Mike Williamson Validation) post? Be sure to like, share, and subscribe!

One thought on “Revision to EudraLex Volume 4 August 2014”

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