In this section
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 Divisionof the MHRA.
The Inspectorate is divided into five medicines inspectorates.
Good Clinical Practice (GCP) Inspectorate
'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'
(Definition from EU Directive 2001/20/EC (external link), article 1, clause 2).
Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.
The principles of good clinical practice are outlined in articles 2 to 5 in the EU Directive 2005/28/EC (external link).
ICH Topic E 6, the ICH Note for Guidance on Good Clinical Practice is an international standard for GCP. It was adopted by the CPMP (CPMP/ICH/135/95) in July 1996 and became operational in the European Union (EU) in January 1997. The ICH Note for Guidance on GCP replaced the previous European Community GCP guidelines, which were implemented in 1991.
Good Pharmacovigilance Practice (GPvP) Inspectorate
By conducting inspections at the sites of marketing authorisation holders, pharmacovigilance inspectors assess compliance with the requirements of legislation and guidelines relating to the monitoring of the safety of medicines used in clinical practice.
Each inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly. From April 2009, the MHRA began a risk-based inspections process making the scope, frequency and depth of inspections dependent on how a company takes responsibility for its compliance with the regulations.
Good Distribution Practice (GDP) Medicine Inspectorate
Good Distribution Practice (GDP) forms part of quality assurance, which ensures that products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification.
The GDP Inspectorate inspects such companies and their operations to verify their compliance with the EU GDP guidelines (external link).
Good Laboratory Practice (GLP) Monitoring Authority
Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.
These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied on when making risk/safety assessments.
In 1998, the Organisation for Economic Cooperation and Development (OECD) issued the revised principles of GLP and compliance monitoring. These were adopted by the European Commission in October 1998 and issued as Directives 99/11/EEC and 99/12/EEC. Consequently, in 1999, the UK Regulations were updated by SI 3106 (external link), as amended by SI 994, 2004 (external link), and are accompanied by a guide that interprets them and explains how compliance will be verified.
Good Manufacturing Practice (GMP) Medicine Inspectorate
The principles and guidelines of GMP are adopted by the European Commission under powers conferred by Council Directive 2001/83/EC (external link). The objective of GMP is to ensure that products are consistently produced and controlled to particular quality standards.
Commission Directive 2003/94/EC (external link) (the 'GMP Directive') sets out the requirements relating to the implementation of GMP for medicinal products for human use (including investigational medicinal products).
The GMP Directive broadens the definition of GMP set out in Directive 91/356/EEC (external link) and repealed the previous Directive in its entirety.
Since 2005, following the implementation of Directive 2004/27/EC (external link), it is now a legal requirement for active substances to be manufactured according to GMP.
From April 2009 the MHRA began a risk-based inspections process making the scope, frequency and depth of inspections dependent on how a company takes responsibility for its compliance with the regulations.
Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 - the 'Orange Guide'
This publication brings together the main pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when making and distributing medicinal products in the European Union and European Economic Area.
It is of particular relevance to all holders of manufacturer’s licences and wholesale dealer’s licences and to their Qualified Persons (QPs) and Responsible Persons (RPs), who are accountable for ensuring compliance with many of these regulatory requirements.
