Annex 16: How a QP should handle unexpected Deviations

In a recent blog of the MHRA, the inspectorate looks at one aspect of the new Annex 16 – the handling of unexpected deviations.

see http://www.gmp-compliance.org/enews_05428_Annex-16-How-a-QP-should-handle-unexpected-Deviations_15432,15354,15367,Z-QAMPP_n.html

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.

Pre-requisites

Before a QP releases a batch these pre-requisites…