GovWire

Overview

Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

• be of consistent high quality
• be appropriate to their intended use
• meet the requirements of the marketing authorisation (MA) or product specification

Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

Organisations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include:

• manufacturer licence holders
• wholesale dealer licence holders
• blood establishment authorisation holders
• non-UK sites employed by UK MA holders

The Medicines and Healthcare products Regulatory Agency (MHRA) carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.

If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the Veterinary Medicines Directorate.

MHRA and the European Medicines Agency (EMA) have published guidance on GMP and GDP:

• Volume 4 of the rules governing medicinal products in the EU
• EU GDP guidelines
• Orange guide: rules and guidance for pharmaceutical manufacturers and distributors 2022
• Green guide: rules and guidance for pharmaceutical distributors 2022
• Guidance for UK manufacturers licence and manufacturers authorisation holders (for investigational medicinal products) on the use of stand alone contract laboratories (PDF, 185 KB, 3 pages) - on the use of standalone contract laboratories

Types of inspection

Inspections under the risk-based compliance programme

Every manufacturer and wholesaler has a risk rating or score and we prioritise inspections for those with the highest ratings or scores. You will be told about these inspections in advance, although under the short-notice inspection programme we may send little or no notification. At the inspection, GMP and/or GDP inspectors examine the systems used to manufacture and/or distribute medicines.

Your GMP rating is based on:

• your compliance report
• internal information about previous inspection history
• organisational changes

You cant appeal against your rating.

An increase in risk will be peer reviewed by a GMP operations manager, a member of the compliance management team (CMT) or a GMP expert inspector before being finalised.

You will be given a full copy of the reasons for your risk rating once the inspection has closed.

For GDP inspections your risk score is based on what activities take place on site and the number and type of deficiencies observed. This indicates the likely date of your next inspection and this information is included on the inspection report.

Inspections may sometimes be carried out with other MHRA inspections, such as with good clinical practice or good pharmacovigilance practice.

Product-related GMP inspections

MHRA conducts product-related GMP inspections when assessing an application for a UK marketing authorisation. This inspection checks if the manufacturer complies with GMP. We tell you about this inspection in advance.

Product-related inspections can also be requested by the European Medicines Agency (EMA):

• Committee for Human Medicinal products (CHMp) during the pre-application of a centralised marketing authorisation application
• Co-ordination group for Mutual Recognition and Decentralised Procedures human (CMDh).

EMA uses inspectors from EU member states to ensure compliance with GMP principles.

Triggered inspections

MHRA may inspect you if were informed about possible GMP or GDP breaches by:

• a whistleblower
• other MHRA departments
• another regulatory authority

We may send little or no notification of these inspections in advance.

Complete a compliance report

You will have to complete either a GDP or GMP compliance report before an before an inspection unless it is a triggered inspection which are only notified at short notice.

You should send completed compliance reports to the email address given by the inspector. Hard copies of compliance reports will not be accepted.

• GDP compliance report (MS Word Document, 251 KB)
• GMP pre-inspection compliance report (MS Word Document, 404 KB)
• GMP interim compliance report (MS Word Document, 342 KB)
• GMP compliance report and interim update guidance (PDF, 104 KB, 7 pages)
• GMP Quality Control Laboratory Pre-Inspection Compliance Report (MS Word Document, 56.2 KB)
• GMP QC compliance report and interim update guidance (PDF, 156 KB, 6 pages)

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