Background

Introduction
The MHRA's Good Distribution Practice (GDP) Inspectorate is part of the Inspections & Standards Division of the MHRA. The GDP Inspectorate inspects such companies and their operations to verify their compliance with the EU GDP guidelines:

EU GDP guidelines

Companies which manufacture or wholesale medicinal products may only do so if they hold the appropriate licence. For further information please see the following section:

Manufacturer's and Wholesale Dealer's licences

What is 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.

Who are we?
The GDP Inspectorate has a team of inspectors based at the MHRA headquarters in London (151 Buckingham Palace Road) and at two MHRA outstations (Welwyn Garden City and York). In Northern Ireland inspections are performed under the scope of a Memorandum of Understanding between MHRA and the Department of Health, Social Services and Public Safety (external link).

Memorandum of Understanding between MHRA and the Department of Health, Social Services and Public Safety (56Kb)

The chart below illustrates the Good Distribution Practice (GDP) team structure:

Good Distribution Practice (GDP) team structure (21Kb)

What do we do?
Inspections of UK sites are carried out whenever a company has applied for or been named on an appropriate licence and periodically thereafter during the course of a licence. Additional inspections that may be required to be performed are, for example, to follow up deficiencies raised previously, following reports of defective products, or to follow up information received from external sources, for example 'whistleblowers'. Applications to vary details of the manufacturing authorisation may also trigger an inspection.

Fees are charged for inspections and they are conducted on a defined frequency in accordance with EU guidelines, unless circumstances dictate otherwise. There is no legal requirement to notify the licence holder of an intention to visit and inspections may be pre-notified or unannounced.

The Good Distribution Practice (GDP) Inspectorate inspects a number of types of wholesale dealer companies, including both human and veterinary products, full line and General Sales List (GSL) only wholesalers.

The Good Manufacturing Practice (GMP) Inspectorate inspects a number of types of manufacturing companies.

Additional information is available in our Good Manufacturing Practice (GMP) section.

External liason
International liaison
International co-operation has been an important part of the Inspectorate's activities for many years. The UK Medicines Inspectorate was a founder member of the Pharmaceutical Inspection Convention and is an active participant in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) (external link).

Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Consultative Committee
The GMP/GDP Consultative Committee has two primary objectives:

• To advise and provide information to representatives of Professional and Trade Associations, the wider Department of Health and Other Government Departments (OGDs) with respect to aspects of Good Manufacturing Practice and Good Distribution Practice and the licensing of manufacturers and wholesale dealers
• to provide a forum for consultation and discussion.

The Committee meet hold at least one meeting each year and include representatives from Inspection, Enforcement & Standards Division of the MHRA including Inspectorate and Licensing Groups, British Pharmacopoeia (BP) and Laboratory Services, Regulatory Advice and Divisional Secretariat. The committee also includes representatives from interested Trade Associations and Professional Bodies and wider Department of Health and other Government Departments.

The Committee meet to discuss:

• Regulatory and international matters related to GMP and GDP
• the performance of operation of the GMP/GDP Inspectorate and the Licensing Office for manufacturers and wholesalers
• interpretation of the Principles of GMP/GDP by the Regulatory Authorities
• compliance by Licence Holders (in general) with GMP and GDP
• technical aspects of GMP and GDP.

History
The Medicines Inspectorate was established within the Medicines Division of the Department of Health and Social Security (DHSS) in 1971 in accordance with the Medicines Acts 1968 and 1971. It was set up to inspect and ensure compliance with Standard Provisions (including Good Manufacturing Practice and Good Distribution Practice) by all applicants for, and holders of, Manufacturer's and Wholesale Dealer's Licences in the UK.

Over the next few years it absorbed the functions of the Department of Health (DH) Inspectorate under the repealed Therapeutic Substances Act, which was only concerned with biological products, and expanded to inspect manufacturers in other countries exporting products to the UK.

In 1975 inspections of NHS manufacturing units were begun at the behest of the then Secretary of State for Health. With the removal of Crown Immunity in 1991 these units were required to hold licences and became subject to statutory inspection.

In April 1989 the MCA was established following the Cunliffe-Evans report into the control of medicines. This brought two major changes. Firstly, the Agency was organised into multi-disciplinary functional groups. This has gradually evolved over the years to reach the present organisation based on pre- and post-licensing activities. The Inspectorate became part of the Inspection and Enforcement Division responsible for inspection, licensing, testing and other activities associated with manufacture and distribution. Secondly, the Agency was to be entirely funded by licence holders on the basis of user fees.

In 1991 requirements for manufacturing authorisations and GMP were harmonised within the European Community. The UK no longer inspected or exchanged Pharmaceutical Inspection Convention (PIC) reports on manufacturers in other EC Member States.

Contacts for further information
For questions related to the planning of inspections please contact gdp.inspectorate@mhra.gsi.gov.uk