Good Laboratory Practice (GLP) accredited
Alderley Analytical is proud to be Good Laboratory Practice (GLP) accredited, being a member of the Medicines and Healthcare products Regulatory Agency (MHRA) GLP monitoring programme, which mean our processes are regularly inspected. This allows us to support non-clinical safety studies that require GLP compliance.
What is GLP?
GLP is a quality system associated with non-clinical safety testing of a drug before it is first used in humans. Introduced by the Organisation for Economic Co-operation and Development (OECD) in 1982 and in 1997 the UK GLP regulations came into force, this ensures the uniformity, consistency, reliability, reproducibility, quality and integrity of non-clinical safety tests throughout its 35 member countries.
Alderley Analytical is legally required to comply with the regulations for our non-clinical safety studies to be accepted by regulatory authorities worldwide. GLP consists of a number of requirements to ensure the fully documented integrity of a non-clinical safety study. It ensures that the organisational processes and conditions under which non-clinical health and environmental safety studies are:
This means that we provide clarity around the responsibilities of key people involved in the study eg the Study Director, ensure Quality Assurance personnel are assigned to the study, keep our facilities and equipment maintained to the highest standards, use robust test systems, have documented standard operating procedures, monitor both the plan for and conduct of a study and finally report on and archive results in accordance with the regulations.
You can view our GLP certificate here.