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Analytical Method Transfer In Focus in EU Effort to Revise GMP Chapter 6 on Quality Control

Dec 11th, 2010

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The transfer of analytical laboratory methods within and between companies is being targeted by the European Medicines Agency (EMA) to receive more attention in a revision to its EU GMP Guide Chapter 6 on quality control.

A recently released concept paper from the EMA outlining its intentions for the revision proposes that a new section be added to Chapter 6 on analytical methods transfer and explains why the area warrants increased attention in the EU GMPs.  Comments on the concept paper are due by the end of February.

The paper stresses that inspectors have been observing that root causes for out-of-specification (OOS) results “sometimes” point to a lack of test method validation in the context of analytical method transfers between laboratories in the same company and “frequently” do so with methods transferred to contract testing laboratories.

As a result of the inspection findings and the increase in the number of method transfers within and between companies and countries “the need for guidance for transfer of analytical methods has been identified,” EMA explains.

The focus on contracting, and the outsourcing of analytical testing in particular, has been increasing in Europe, the US and Japan as part of their efforts to better regulate an increasingly complex global manufacturing and supply chain.

[More on the EMA concept paper how it fits into the increasing focus in the ICH regions on contracting and supply chain relationships is provided for subscribers beginning on page 2.  To subscribe to IPQ, click here.]

Recent related IPQ coverage referenced later in this story:

Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5

New Draft Broadens EU GMP Guide Chapter 7 from Contracting to All Outsourced Activities

Japan’s Foreign Inspections Reveal Communication Chain Gaps

New Warning Letters in US Focus on Process Validation and Sponsor/Contractor Relations

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds

FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape

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