EU Releases New Process Validation Guidance to Reflect Risk-Based Approach
Thursday, April 9, 2015
Source: FDA News
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.