Concept Life Sciences, the integrated drug discovery, development and analytical services company, completed the first phase of its GXP compliance plan, achieving GLP (good laboratory practice) accreditation of its site in Dundee, Scotland, for in vitro safety studies and bioanalysis.
The successful inspection by Medicines & Healthcare products Regulatory Agency (MHRA), was carried out at Concept’s Dundee site in December 2017, confirming GLP accreditation for in vitro safety studies and bioanalysis. The accreditation increases the breadth of services the company is able to offer to customers requiring regulatory studies, and provides assurance of data integrity and compliance with international standards, ensuring acceptance of the data by global regulatory bodies.
GLP refers to a quality system of management controls to ensure uniformity, consistency, reliability, reproducibility, quality and integrity in non-clinical laboratory studies and gives confidence in the safety assessment of a compound. GLP applies to the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products, and also to many other non-pharmaceutical agents such as colour additives, food additives, food contamination limits, food packaging, and medical devices.
The accreditation forms part of a phased plan over H1 2018 to expand GXP compliance (including GLP and GMP) at the company’s facilities, to expand services to manufacture of API (active pharmaceutical ingredient) material, and to further support development of compounds from the discovery stage to full investigational new drug application (IND) packages.