Handling of unplanned deviations
Article 42
Where an unplanned deviation related to the manufacturing process or the analytical control methods has occurred, a qualified person may confirm compliance or certify the batch only if the following conditions are met: (a) the specifications for active substances, excipients, packaging materials and finished product are complied with; (b) there is an in-depth assessment of the impact of the deviation which supports a conclusion that the occurrence does not have a negative effect on quality, safety or efficacy of the product; (c) where appropriate, the need for inclusion of the affected batch/batches in the on-going stability programme has been evaluated.