The accreditation comes after a 2.5-year period of investment, during which the company created its facility and brought together a team specialising in API development and manufacture
Concept Life Sciences (CLS), a Malvern Panalytical brand, has received certification of GMP compliance for the production of active substances at its site in Sandwich, UK. This follows an in-depth Medicines and Healthcare products Regulatory Agency (MHRA) inspection and applies to active pharmaceutical ingredients (APIs) for both human and veterinary use.
The certificate reportedly demonstrates compliance to safe practices and enables the company to extend its offering to customers, supporting pharmaceutical developers from discovery and early development of candidate molecules to manufacturing drug substances for clinical trials.
The accreditation comes after a 2.5-year period of investment, during which the company created its facility and brought together a team specialising in API development and manufacture.
Mark Carnegie-Brown, VP of the Malvern Panalytical Pharmaceuticals and Food sector, said: "We have always been driven by a strong desire to be the best partner we can be to our clients. This means working to the very highest standards, and the MHRA’s accreditation of our compliance with GMP is a clear reflection of how our people, infrastructure, analytics, skills and processes combine to achieve excellence for our customers."
Liz Savage, Head of Quality at CLS, said: "We work in partnership with our clients to deliver tailored, high quality and comprehensive drug discovery and development programs," said Liz, "so having a GMP-certified facility further simplifies collaboration by providing upfront assurance that our facilities are compliant, without the need for our clients to undertake additional time-consuming audits".