PREFACE TO THE 2013 EDITION

The U.S. FDA has provided a guideline, in the latest revision of “ Guidance for Industry, Process Validation: General Principles and Practices (2011) “, that Qualification of Utilities and Equipment should be planned, performed and documented, and the Qualification Plan and Report be reviewed and approved by the Quality Control Unit during the validation lifecycle. This guideline is consistent with those of the international organizations such as ICH 7 (2001), EudraLex - Volume 4 (Annex 15) (2001), WHO TRS 961 (Annex 3) (2011), and PIC/S GMP Guide (Part II) (2013), which require DQ, IQ, OQ and PQ for qualification of pharmaceutical manufacturing facilities. Since the Science- and Risk-Based Approach as explained in ICH Q9 (2006), ICH Q10 (2009) and ASTM E2500 - 07 (2007) allows to utilize the test data taken from FAT (Factory Acceptance Test), SAT (Site Acceptance Test) and Commissioning as the evidence of qualification, it is very important now that all project participants including plant design firms, equipment manufacturers, construction firms, and the owner company must clearly understand the GMP requirements for the new plant in the as earliest stages of the project as possible.

As the supplier of the detailed qualification protocol examples, we are very pleased to publish this 2013 Edition which has incorporated the latest version of the guidelines for validation provided by the major regulatory agencies around the world. We believe that this edition will help our customers keep abreast of the current qualification practices for pharmaceutical plants. Again, we sincerely hope that our customers have great success in their validation projects.

Peter Byonghyock Choi, Ph.D., P.E.
PLANTVALIDATION.COM
Wayne, Pennsylvania
Last Modified on April 23, 2013