Management Responsibility in Good Laboratory Practice Prof. Praveen Sharma
Professor, Department of Biochemistry, All India Institute of Medical Sciences, India
Good Laboratory Practice (GLP) refers to a Quality system of management controls for research laboratories (non-clinical) and organisations, which is now being extended to other laboratories as well. It embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. Test facility management means the person(s) who has the authority and formal responsibility for the organization and functioning of the test facility according to the Principles of Good Clinical Practice. There are several management responsibilities in GLP. Laboratory management responsibilities and organisational requirements take up about 15% of the GLP. Without full commitment of management, GLP systems will not function as they should and will lack credibility. Managerial aspects are therefore critical for GLP implementation in a laboratory. The management responsibilities do vary as per ISO 15189 and Clinical and Laboratory Standards Institute (CLSI). Management has overall responsibility for ensuring that all documentation, personnel, procedures, supplies etc. are following principles of GLP. The development and implementation of an effective Quality Management System is the primary responsibility of the Management. The initiatives taken on the part of the management shows its commitment towards continual improvement of the laboratory processes.