EU Issues Annex 15 Guide on Qualification and Validation

The final version of the EU GMP Guide Annex 15 has been issued, and will become effective on October 1, 2015. There are some important points in this documents to consider:

1. Retrospective validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of the product, operating procedures, or equipment.

2. Revalidation of facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid. If there haven’t been changes, there should still be a formal review with data that the facilities, systems, equipment and processes still meet the requirements.

3. Risk analysis should accompany all change control for product quality or reproducibility of the process, including any changes in facilities, systems, and equipment.

4. The guide generally considers three consecutive batches/runs within the final agreed parameters to constitute a validation of the process.

Download the final revised guidance here.