Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!
When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …
The MHRA GMDP Inspection Teams work closely with the Veterinary Medicines Directorate (VMD) Inspection Teams to ensure that manufacturers and distributors of Veterinary Medicinal Products (VMPs) are inspected appropriately and to the correct standards.
Following on from the previous DMRC overview post, here are some Do’s (What, When & How) for reporting defects to the DMRC, and also some Don'ts to avoid.
Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.
Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …
The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). …
A year ago today we launched the MHRA Inspectorate blog. Now, after 12 months of activity it’s a good time to reflect on where we are and what’s to come.
Every batch of medicinal product must be certified by a Qualified Person (QP) of the EU manufacturer or importer before being released for sale. The certifying QP takes responsibility for ensuring that each batch has been manufactured and checked in …
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. …
