In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)
Alan Moon Joined the MHRA in July 2013 as a GMDP Inspector and was promoted to Senior Inspector in 2017. Alan is an Applied Biological Sciences graduate and has inspected in areas including sterile manufacturing, non-sterile manufacturing and investigational medicinal products. Prior to joining the Agency, he worked in the pharmaceutical industry for approximately 20 years in various roles including Quality Control, Quality Assurance and Production.
At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …
The GMP Inspectorate works closely with the Clinical Trials Unit (CTU) at MHRA and regularly provides support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licensing requirements and general handling of Investigational …
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