Successful Inspection as Melbourn Scientific Extends Facilities
News Aug 17, 2009
Melbourn Scientific has once again completed a successful UK MHRA GMP (Good Manufacturing Practices) audit providing a seal of approval for its services.
Carol Barbour, Director of Quality, explains that as an approved contract testing laboratory, clients can identify Melbourn as a testing facility on their manufacturing license applications and be confident in knowing that the facility is acceptable to the authorities reviewing their application.
“GMP is mandatory for various later stages in the development of pharmaceuticals therefore using us as a partner in drug development programmes will enable small companies and larger pharmas to fast track their products through to release, maximizing the benefit achieved from early approval of products. There are also advantages where clients are at an earlier stage in the development process.”
“Although early research does not need to be performed in accordance with GMP, having work performed to a recognized Quality Standard gives confidence in the results, helping facilitate any due diligence processes if IP is being shared with external partners and potentially increasing the value placed on this data.”
Melbourn is currently expanding its facilities for work on early stage formulation development by the creation of a suite of rooms specifically for this function. These rooms will allow flexibility to support multiple projects running at the same time.
“By offering our clients analysis, formulation development and small-scale production on one site, it is possible to screen a wide range of formulations, in a cost and time effective manner, in order to identify those most likely to succeed,” Carol continues.