Brexit – Planning for a duplication of product testing: serving patients in both the UK and the EU
It is estimated that more than 2,600 pharmaceuticals, approved in the EU utilise UK based companies to provide an aspect of the manufacturing, packaging and subsequent logistics network to get these life-saving medicines into the hands of patients.
As a consequence an estimated 45 million patient packs are supplied from the UK to other European countries, each month, for use in healthcare provision and improving patient outcomes. Conversely, supply chain logistics outside of the UK account for some 37 million patient packs flowing into the UK under the same regulatory framework.
The future of this reciprocal arrangement is under threat through the ongoing Brexit negotiations.
Here at Tepnel Pharma Services we are working on providing solutions for both our existing partners and anyone looking to mitigate against the future of the UK becoming a “Third Country” in relation to the current EU regulatory requirements around batch release testing.
We believe that it is never too soon to start planning for the potential outcome of the ongoing negotiations and irrespective of the outcome, patient safety and improving patient outcomes has to be the primary objective.
We are here to answer your questions and support you through these uncertain times. Call the team today on:
+44 (0)1506 424271 or email: email@example.com
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Tepnel Pharma Services is MHRA certified for the following types of cGMP testing;
- Chemical/Physical testing
- Microbiology: sterility
- Microbiology: non-sterility (includes LAL endotoxin testing and environmental monitoring)
The types of testing, in compliance with GMP that we can provide, include (but are not necessarily limited to):
- Finished products (testing for batch certification by a Qualified Person)
- Investigative Medicinal Products (batch release testing of IMPs for use in human clinical trials)
- Stability testing (for marketed products or IMPs)
- Starting materials or excipients (testing of active or other product ingredients for compliance with raw material specifications)
- Process waters or process intermediates (most frequently testing of water samples)
- Samples from environmental monitoring (This includes both the performance of environmental monitoring in production areas, and/or the incubation/assessment of environmental monitoring samples provided by the manufacturing site)