The coming into force of a significant revision of EU GMP Annex 15 in early October, and its insertion into the PIC/S GMPs, has created heightened attention on the evolving global process validation expectations at recent public forums.
The Monthly Update for October explores: ● the changes made in the revision and their impact ● how the annex now compares with FDA’s process validation guidance, and ● what regulators around the world are now expecting and the problems they are finding during inspections in reviewing industry’s PV performance.
The stories include an inside look at the context and result of the Annex 15 revision process through the lens of the revision rapporteur, MHRA’s Norman Gray.
This year’s ISPE/PQRI process validation forum took place only a few days after Annex 15 came into effect and provided a very timely opportunity for Gray to offer his insights into the revision process, the changes made and their significance, and the problems MHRA inspectors like himself are currently seeing in the PV arena. In accord with their receiving heightened attention in the revised annex, 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.
A second story in the IPQ Monthly takes a look at what the process validation regulatory landscape now looks like in the Asia Pacific region and the impact that PIC/S is having in reshaping GMP expectations and those for process validation in particular. The coverage piggybacks on the knowledge sharing that has been taking place across the ISPE Asia network, which was reported on at the ISPE/PQRI forum by an industry consultant actively involved with the association’s activities in Asia.
The third story shifts focus to insights provided at the PDA/FDA conference by a key process validation policy maker at FDA – Office of Pharmaceutical Quality’s Grace McNally – on the current agency PV expectations and concerns and how the US PV guidance and new EU annex align.
Included are about 30 “Updates in Brief” on breaking developments, which include links to all the documents referenced and to our related in-depth stories. Also in the issue is a full listing of the drug GMP warning letters and recalls posted by FDA during October.
To access the Monthly Update, subscribers please, click here.