Inspection and standards

Quality underpins both safety and efficacy and the MHRA promotes the understanding and development of quality assurance in the development, manufacture and distribution of medicinal products. This section of the site explains how the MHRA carries out this area of work and includes sections on:

Inspection
Inspection of research, development and quality control laboratories, clinical trials, manufacturers, wholesalers and pharmacovigilance systems is carried out by the Inspectorate Group of the Inspection and Standards Division.

Good Clinical Practice (GCP)
GCP inspectors assess compliance with the requirements of GCP guidelines and applicable regulation. GCP guidelines and regulations provide a standard for the conduct of clinical trial research.

Good Manufacturing and Distribution Practice (GMP/GDP)
GMP inspectors assess manufacturers compliance with the provisions of their manufacturing authorisation and the principles and guidelines for GMP as detailed in the appropriate European Directives. GDP inspectors assess Wholesale Dealers' compliance with the provisions of their Wholesale Dealer's licence and the principles and guidelines for GDP.

Good Laboratory Practice (GLP)
GLP inspectors verify that test facilities which conduct non-clinical safety studies on pharmaceuticals, agrochemicals, industrial chemicals, food and cosmetics meet GLP requirements to the standards necessary for regulatory purposes.

Good Pharmacovigilance Practice (GPvP)
Pharmacovigilance inspectors assesses pharmaceutical companies' compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients.

British Pharmacopoeia
UK Pharmacopoeial activity is carried out within the Inspection and Standards Division of MHRA by the Pharmacopoeial Secretariat Group and the BP Laboratory Unit.

Pharmacopoeial standards are objective, public standards of quality for medicines and their components. The Pharmacopoeia is an important statutory component of the overall system for the control of medicines which complements and assists the licensing and inspection processes. All three statutory components complement and support the quality assurance system operated by the manufacturer. Quality underpins both safety and efficacy and quality assurance is a continuous process.

Medicines testing
The MHRA's Medicines Testing Unit, supports the MHRA 's commitment to safeguarding public health by sampling and testing selected medicinal products on or destined for the UK market.