Alan Moon

Alan Moon Joined the MHRA in July 2013 as a GMDP Inspector. 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.

Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2

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)

Overview of compliance management escalation processes used by the GMP Inspectorate

Posted by: Alan Moon, Posted on: 6 February 2017 - Categories: Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate

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 …

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

Posted by: Alan Moon, Posted on: 20 May 2016 - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

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 …