Highlights of latest revision of EU GMP Guidelines

In August 2014, the EU commission published revisions to Chapter 3 "Premises and Equipment" and Chapter 5 "Production" of the EU GMP guideline, that will take effect on March 1, 2015. We have put together a brief summary of both revisions in order to keep you informed on the current state of these guidelines.

Prevention of cross-contamination

The revisions concern cross-contamination in the production area. It clearly states that the measures to prevent cross-contamination should be linked with the associated risk. In addition, the revised guideline prescribes a risk-based approach for supplier qualification. The amount of supervision required should be proportionate to the risk posed by the individual starting material, taking source, manufacturing process, supply chain complexity and final use of the material into account. Quality Risk Management Principles, including potency and toxicological evaluation, should be used to assess and control the risk.

Quality agreements formalized

A new section on supplier qualification and supply chain traceability was added to the guideline and for the first time an explicit reference was made to quality agreements. Thus, the already existing expectation of authorities to see a quality agreement in place between a drug product manufacturer and its supplier is now formalized in the revised EU GMP guideline.

At Merck we are committed to anticipating new regulatory guidelines, and so we have already acted. We have set up a harmonized standard template that enables us to include the various Merck product groups in the same contract. This will allow us to handle the increasing number of quality agreements more efficiently.

Please join us on December 11, 2014 for an informative webinar providing an update and further information on the current practices regarding quality agreements.

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