Inspections
The Quality Team at JensonR+ have been incredibly busy, with three successful MHRA GDP inspections in as many days, one routine inspection and two new applications, for our clients.
These exceptional outcomes are all credited to the hard work of our Responsible Persons’s (RPs), their relationships with our clients and the wider GDP team who provided support throughout the preparations and during the inspections. It is especially impressive as GDP expectations have increased significantly in recent years, with an increasing number of companies having their Wholesale Distribution Authorisations, suspended, or revoked due to poor levels of compliance.
Why are GDP inspections so critical?
First and foremost, for patients. Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification. MHRA approval is a prerequisite for companies to be able to supply medicines in the UK, and therefore making medicines accessible to patients.
How do JensonR+ support our clients through inspections?
We perform initial gap assessments against current GDP expectations and then implement any actions required within the Quality System. As RPs we then work within our clients Quality System(s) to ensure that current GDP requirements are consistently achieved and we share the latest information within our network to drive continuous improvements for our clients.
Our Quality team have experience preparing for and hosting MHRA inspections and ensure that both your site and teams are inspection ready. Post-inspection, we can help address any deficiencies raised and support you with any MHRA responses.
Get in touch at consultancy@jensongroup.com.
- EMA and PIC/s Issue Concept Paper for GMP Annex 11 (Computer Systems) - December 1, 2022
- Inspections - November 1, 2022