Planning for a positive outcome post-Brexit
As a business, Tepnel Pharma Services has been closely following the on-going Brexit negotiations and EMA requirements surrounding marketing authorisation holders (MAHs) of centrally authorised medicines products for human and veterinary use. It is our position that we (the UK) should not diverge from EU regulation and that we must continue to co-operate with the European Medicines Agency supporting MAH’s of CAP’s.
Whilst we will continue to be active in our lobbying and contribution to government discussions and industry body opinions we also recognise that contingency planning and provision cannot be left to the last moment.
If you are a holder of centrally authorised medicinal products, contact us today to discuss how Tepnel could assist you in the planning for the worst case scenario: the UK being recognised as a Third Country as of 30 March 2019.
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Our organisation is currently listed on 42 UK product licences and 45 Manufacturing licences supporting both authorised products and investigational medicinal products. With a heritage of quality control testing that spans over 30 years. We believe that considering Tepnel in your post-Brexit contingency planning will provide you with a partner who has a demonstrable track record for delivering positive outcomes for clients, and ultimately patients.
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)