6 top tips for applicants submitting a Manufacturing Authorisation application or variation
My name is Lynsay Hunter and I am the newest recruit to the MHRA laboratories inspection team, having previously worked in a variety of laboratory and quality assurance roles. My first MHRA event was the annual laboratories symposium held in …
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 …
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.
On 22nd September 2016 the MHRA Inspectorate will be holding another GLP and GCP Laboratories Symposium.
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.
The GLPMA website has been updated recently to include two new documents, a summary of inspection findings from 2014 and a guidance document relating to the use of test sites that have not been inspected by their national GLP monitoring …
