Quality Assurance

Intertek ASG Laboratory, Manchester, UK

Regulatory Analysis, Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)

Intertek ASG's capabilities can be deployed in regulatory submissions and product release analysis. Within the United Kingdom, GLP is enforced by the UK GLP Monitoring Authority which operates within the Medicines and Healthcare products Regulatory Agency (MHRA).

Good Laboratory Practice (GLP):

ASG has been a member of the UK GLP compliance programme since 1987 for the provision of chemical characterisation and physical, chemical data to support the worldwide registration and notification of new chemical products and intertmediates, including submissions to the US EPA and Japanese MITI regulatory agencies. A statement of GLP compliance, issued by the monitoring authority via their biennial inspection programme has been maintained since 1987. As well as maintaining the internal GLP system, Intertek ASG also provides GLP auditing services to client organisations.

Good Manufacturing Practice (GMP):

The Intertek ASG Laboratory also has cGMP compliant systems to allow extensive analytical contributions to pharmaceutical research, development and quality control.

Regulatory Archive Facility:

Dedicated on-site regulatory archive which provides secure storage facilities for data and specimens. The archive is managed by the Quality Assurance Unit and operates to documented SOPs.