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 Manufacturing Practice (GMP)
GMP is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification. GMP is concerned with both production and quality control.

Good Distribution Practice (GDP)
GDP is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the MA or product specification.

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 Clinical Practice for clinical laboratories
Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”

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.