This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As outlined in the first part of this blog, the MHRA is starting a pilot in …
A founder member of the GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full range of UK distribution companies. He was a member of the PIC/S GDP working group, working on the training and aligning of GDP standards for PIC/S member countries. He was part of the EMA GDP drafting group preparing the GDP Guidelines and updates to the compilation of community procedures and involved in training the GMDP inspectors on the new guidelines.
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022. The MHRA has a history of implementing risk-based inspection practices: 2009: The risk-based inspection programme …
The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
In my last post I talked about the importance of ensuring medicines are only obtained from qualified suppliers. Equally important is the obligation distributors have in ensuring that only wholesalers or persons entitled to supply or administer medicines receive medicinal products. …
We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …
Related content and links
About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
Other MHRA Blogs
Comments and moderation
- MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use
- Return to International GMP Inspections
- Innovation, Quality & Transparency – a Compliance Team 1 Perspective
- Decommission of eSUSAR
- Compliance Monitor Process (Part 2)– CM role and application process