New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …
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.
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)
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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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
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- Compliance Monitor Process (Part 2)– CM role and application process
- Compliance Monitor process (Part 1) – An introduction
- MHRA Good Practice Symposia Week (7 to 11 March 2022)
- Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
- Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned