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.
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.
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.
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)
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.
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 …
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.
MHRA Inspectorate & Process Licensing Organogram
Other MHRA Blogs
Comments and moderation
- Pharmacovigilance Inspection Metrics April 2020 to March 2021
- Global reflections on international inspection transformation: ICMRA remote inspections
- Supply Chain webinar: recording now available
- Updated data integrity requirements for GLP Monitoring Programme members
- MHRA and US FDA tackle challenging data integrity