Risk Assessments, Data Integrity, Documentation, and Deviations Will be High on EU Radar Screen in Auditing Process Validation With Revised GMP Annex 15 In Effect

Risk assessments, data integrity, documentation organization and deviation handling are issues that will be high on the radar screen of European inspectors in reviewing how companies are validating their processes, in accord with the increased emphasis the issues have received in the revision of EU GMP Annex 15.

Annex 15, which covers the qualification and validation of processes from a GMP vantage point, became effective at the beginning of October.  The PIC/S GMPs match those in Europe, and PIC/S followed suit in adopting the annex revision in early October. [Editor’s Note: See IPQ October 30, 2015 for a review of the impact PIC/S is having on the process validation expectations in the Asia Pacific region.]

The EU last revised the annex in 2001. A concept paper explaining the motivations for the revision was released by EMA’s GMP/GDP Inspectors Working Group (IWG) for comment in late 2012 (IPQ February 12, 2013). Among them are technology advances, changes to the EU GMPs, the incorporation of ICH Q8-11 quality management principles in alignment with FDA’s PV guidance, and the rewrite of the PV drug product submission guidance.

A draft of the Annex 15 revision was issued for comment in February 2014. The final version, amended to reflect the comments, was issued in April 2015 – effective six months later.

The EU “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” reached its final form in early 2014 and became effective the following August. [Editor’s Note: For an analysis of the final PV submission guideline and its relationship with the Annex 15 rewrite effort see IPQ March 27, 2014.]

Providing a timely review of the newly effective Annex 15 at the ISPE/PQRI meeting on process validation held at the beginning of October was its rapporteur, UK Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMPD Inspector Norman Gray. In his presentation, Gray discussed: ● the revision process on the annex ● the changes made in the revision ● how it compares with FDA’s process validation guidance, and ● recent MHRA PV inspection findings. 

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