13/14 December 2023
On December 20, the long-awaited draft of Annex 1 was published (Manufacture of Sterile Medicinal Products). The special feature here is that the revised Annex 1 will not be an independent EU document but should also apply directly to the PIC/S guidelines. So the planned revision will replace the current versions of EU-GMP Annex 1 and the PIC /S document PE 009 -11 "Manufacture of sterile Medicinal Products". This is why the draft does not contain any direct references to the term "Qualified Person" (QP); the QP is called here "Person responsible for the quality release of sterile medicines".
In general, the document will be much more extensive and contain some new rules and additions. There are also some things to consider for QPs:
It doesn't really come as a surprise that this so called responsible person should have "appropriate access to manufacturing and quality information and possess adequate knowledge and experience in the manufacture of sterile dosage forms and their critical quality attributes."
But also a few things which need to be considered in the batch certification process are described directly:
Batch release within the Contamination Control Strategy
According to Annex 1, the environmental and process monitoring program should be part of an overall contamination control strategy (CCS). The goal is to minimise the risk of both microbial and particulate contamination. Here, the information from the CCS systems should be "used for routine batch release and for periodic assessment during process review or investigations" [9.3].
Results from monitoring surfaces and personnel and environmental monitoring data generated in grade A and B should also be considered during batch record review [9.11], [10.10].
In those cases where Parametric Release is performed (and has been authorised), the following should also be considered: