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Trevor Watson

I joined the MHRA as a GMDP Inspector in 2014, and my role involves inspecting domestic and overseas manufacturers, and UK importers. I previously worked in the pharmaceutical industry for over 25 years, where I held a variety of QC and QA roles. I am also eligible to be named as a Qualified Person under the permanent provisions of Directive 2001/83/EC.

Maintaining control: Remote working and QP certification

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Laptop, papers, phone and a cup of coffee at a desk

In the modern world it is increasingly common to see flexible, part-time or home working arrangements. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.

Passing the baton from GPvP to GMP: Three top tips for protecting patients and staying compliant

Gentleman consulting with a pharmacist about the medicine she is holding

A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.

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

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
business woman studying some paperwork

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)

Annex 16 QP certification and batch release – frequently asked questions – part 1

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

In this post you’ll find the first in a series of ‘frequently asked questions’ related to the updated EU GMP Annex 16 on QP Certification and Batch Release.