October is here, and updates to the European Commission’s Annex 15 Qualification and Validation are officially in effect.

The update, which was drafted in March 2015, incorporates lifecycle validation requirements similar to those in FDA’s 2011 Guidance on Process Validation. In other words, the updated document requires that a “robust product development process is in place to enable successful process validation” and that GMP requirements for PV should continue through the product lifecycle.

How does the updated Annex 15 affect Asian-Pacific countries?

PIC/S, or the Pharmaceutical Inspection Co-operation Scheme, adopted the updated Annex 15 guidance, and PCI/S has a considerable influence within the Asia-Pacific region: there are eight member countries and several more on their way to becoming members. Because of this, many Asian countries will now have to follow Annex 15 practices.

The introduction of lifecycle validation presents a shift in thinking within GMPs (Good Manufacturing Practices). When we look at the Asia-Pacific region, we see that the maturity of GMP regulation varies widely between counties – some are much further ahead than others.

What does this mean for the pharmaceutical manufacturing industry – in Asia and as a whole?

Expert Maurice Parlane will answer this at ISPE’s 2015 Process Validation Conference. Parlane’s presentation explores the current status of Lifecycle Validation adoption into GMPs within the Asia-Pacific Region, and the issues that stem from it.

The Process Validation Conference takes place from October 7-8 2015 in Silver Spring, Maryland.

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