In a recent blog of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations.
Before Annex 16 was revised, the handling of minor deviations from defined processes was discussed in the European Medicines Agency's "reflection paper" EMEA/INS/GMP/227075/2008. However, the status of this paper was not always clear, and its use was not consistently applied. Now section 3 of the new Annex 16 provides guidance on when a Qualified Person (QP) may consider confirming compliance or certifying a batch where an unexpected deviation (concerning the manufacturing process and/or the analytical control methods) from the MA and/or GMP has occurred.
Before a QP releases a batch these pre-requisites need to be considered:
Quality Management System
Quality Management System failures are not covered by this section. But the quality management system of the manufacturer should maintain a record of which batches have been certified under the respective provisions. And it should also be considered in the management review and annual product quality reviews.
Notification of the Authorities
If the handling of the deviation is in accordance with the Annex 16 restrictions, the competent authority does not need to be informed (see also Chapter 8 of the EU Guide). But manufacturers and importers are required to notify competent authorities of quality problems and non-compliance affecting the Marketing Authorisation (MA).
Please also see the MHRA Inspectorate's blog for more detailed information.