EMA Considering New Guidance for Tech Transfer Test Method Validation
The European Medicines Agency is planning to adopt stricter guidelines on test method validation for technical transfers to CMO's. These revisions to Chapter 6 Quality Control, EU Gudilines to GMP were published in September and the EMA is requesting comments to be submitted to it by February 2011. "Outsourcing-Pharma.com" has a piece about it that you can read here.
According to the article, the EMA is considering changes to Chapter 6 that will include guidance in Annexes 16,19 and 20; ICH Q8, Q9 and Q10; the ICH Q11 draft; on-going changes to Chapters 4,7 and Annex 11; and development of near infrared spectroscopy (NIR) for raw material identification and process analytical technology (PAT).
In this day of increased scrutiny on product submissions by all regulatory agencies, it is surprising to read that test methods are not always being fully validated during a technical transfer from one manufacturing site to another or at contract quality control laboratories. It is important to consider validating test methods during the technical transfer phase at the new site to account for differences in laboratory factors and the methodologies that must be adapted for the new site's equipment. Many times, the test methods being transferred are older and may lack the sensitivity to meet current regulatory requirements.