EU Releases New Process Validation Guidance to Reflect Risk-Based Approach

The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug.

Among major changes in the guideline — which draws heavily on ICH Q8, Q9 and Q10 — is that retrospective validation will no longer be accepted.

In addition, the guideline stresses that risk management should be used to evaluate planned changes to the production process to determine how they will impact quality, documentation, validation, regulatory status, calibration and maintenance — and avoid falling out of compliance, the Commission adds.

The new requirements, effective Oct. 1, are laid out in final revisions to Annex 15 of the EU good manufacturing practice guideline. It applies to the production of both finished drugs and active pharmaceutical ingredients.

The revisions extend the options available for process validation to allow for continuous process verification or a combination of continuous verification and the traditional approach of a minimum of three batches. Products should be monitored to show they meet specified standards and to identify any outlier trends, the guideline says.

Batches manufactured for process validation should be the same size as intended commercial scale batches, the guideline notes.

The guideline also adds new requirements for factory acceptance and site acceptance testing of manufacturing equipment.  For example, companies may perform certain tests on equipment at the factory stage without having to repeat them on site if they can show the items won’t be affected by transportation or installation.

The Annex also outlines requirements for verifying transportation for finished medical products, product packaging and cleaning processes.

The revisions replace a 2001 version of Annex 15. Read the new guidance at www.fdanews.com/04-03-15-Annex15.pdf. — Kellen Owings