Analytical and Formulation Services Provider Receives Manufacturer’s/Importer’s Authorisation

Following further successful GMP inspections by FDA and MHRA, Melbourn Scientific has been awarded a Manufacturer’s/Importer’s Authorisation (MIA) and is to be named as the EU testing and release site for an aseptically prepared medicinal product on a client’s pending Marketing Authorisation Application.

Melbourn Scientific has one of largest teams in Europe offering contract research, including formulation development, analysis, stability studies and small scale manufacture of clinical trials materials. Carol Barbour, Quality Director, said the new licence is a good endorsement of the quality of Melbourn’s procedures and will extend its capabilities.

“With the MIA, we will be able to import commercial products which have been manufactured outside the EU and to test them prior to release for sale within the EU/EEA. 

“We have secured the services of experienced QPs to audit the supply chain and provide assurance that imported products have been manufactured in accordance with the Marketing Authorisation and GMP. We will also liaise with the wholesale/distribution company to ensure adherence to Good Distribution Practice.

“This extends the scope of our services to cover more of the product lifecycle and will be valued by clients who want to outsource these critical activities. Also with our stability storage capabilities, we are able to provide this service if the client requires on-going stability to be performed in the EU.”

QC testing, which includes stability testing of investigational and marketed medicinal products, is regarded by the MHRA as part of the manufacturing process, so laboratories providing this service need to operate in compliance with the EU Guide to GMP.  Melbourn is already GMP certificated so the new licence means that it can offer a complete service, including raw material testing, QC and finished product testing and QP certification prior to release.

Melbourn already has an MIA/IMP (Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products,) which allows the manufacture and importation of investigational medicinal products.

Melbourn Scientific Ltd, +44 1763 261648, www.melbournscientific.com.