The MHRA 's primary objective is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. Safety aspects cover potential or actual harmful effects; quality relates to development, manufacture and distribution; and efficacy is a measure of the beneficial effect of the medicine on patients.
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.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (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.
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Good Clinical Practice (GCP)
The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspections & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.
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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.
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Risk-based inspection programme for good practice inspections
While the MHRA has been incorporating elements of risk management into its inspection programme for a considerable time, the Agency’s commitment to the Hampton principles and the government agenda for Better Regulation has focused efforts in this area.
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Medicines testing
The MHRA's Medicines Testing Unit supports the MHRA commitment to safeguarding public health by sampling and testing selected medicinal products on or destined for the UK market.
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Good Distribution Practice (GDP)
Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification.
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.
The MHRA Pharmacovigilance Inspectorate is part of the Inspections and Standards Division of the MHRA. It assesses pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients.
UK pharmacopoeial activity is carried out within the Inspection and Standards Division of MHRA by the Pharmacopoeial Secretariat Group and the BP Laboratory Unit.
The Inspection Action Group is a non-statutory, multi-disciplinary group constituted to advise the Director of Inspection, Enforcement and Standards Division on any recommendation for regulatory or adverse licensing action appropriate to the Division.
