MHRA GMP and GDP: what it is, who needs to comply, and how inspection works

What is MHRA GMP and GDP?

MHRA GMP and GDP are the good manufacturing and good distribution practice the Medicines and Healthcare products Regulatory Agency enforces under the Human Medicines Regulations 2012. The MHRA grants manufacturer's and wholesale dealer's licences on condition the holder complies, inspects the sites that hold them and publishes the rules and guidance as the Orange Guide.

The Orange Guide gathers the UK legislation, the GMP and GDP guidelines and the MHRA's guidance for licence holders. The current print edition, the eleventh, came out in 2022, and an online version is updated between editions. The GMP guidelines are the EU guide's chapters and annexes as they stood when the Brexit transition period ended, and the MHRA's GxP data integrity guidance of March 2018 applies beside them. No certification body certifies against any of it.

Who needs to comply with MHRA GMP and GDP?

Holders of a UK manufacturer's licence, to make, assemble or import medicines, whose Qualified Person certifies each batch before it is released

Holders of a wholesale dealer's licence, whose Responsible Person sees that the medicines are bought, stored and supplied to good distribution practice

Contract manufacturers, laboratories and logistics providers doing licensed work for a licence holder, and the licence holder who stays responsible for it

The rules become urgent when the MHRA gives notice of the inspection, when the Qualified Person will not certify a batch until the deviation on it is closed, or when a temperature excursion in transit has to be investigated before the stock goes back on sale.

MHRA GMP AND GDP IN QUALIO

Qualio assesses your procedures and records against the MHRA's requirements beside Eudralex and 21 CFR 211, so one set answers each inspector

Qualio lists the MHRA's GMP and GDP requirements one by one, beside Eudralex and 21 CFR 211, and maps your procedures, deviations, change controls and supplier files to the requirements they answer. When a record changes, it reassesses what that record touches and recommends a fix for each gap. Copilot drafts the deviation write-up, and your team approves it. When the inspector asks, you export the evidence by requirement.

Deviations, OOS results, complaints and temperature excursions logged as events against the product and the supplier they concern, each traceable to the investigation and the CAPA that closed it

A procedure or process change routed to the approvers your procedure names, effective on the date you set, with the retraining out that day to everyone who follows it

Contract manufacturers, laboratories and carriers held as suppliers, qualified with an audit schedule set by risk and every SCAR linked to the supplier behind it

Self inspection run as an internal audit event, with each finding tracked as a task on the event until it closes

Standards that apply alongside MHRA GMP and GDP

Pharma manufacturingEU GMP, Eudralex Volume 4: The EU guidelines the UK GMP guidelines were carried over from, read side by side by a site that supplies both markets
Pharma manufacturingEU GMP Annex 11: The annex on computerised systems the UK guidelines kept, read with the MHRA's data integrity guidance wherever a GMP record is held electronically
Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's equivalent for the US market, inspected at the same site on the same procedures when the product is sold there
Pharma manufacturingICH Q10: The pharmaceutical quality system model Chapter 1 of the GMP guidelines is written around
Pharma manufacturingICH Q9: Quality risk management, which the GMP guidelines expect behind the decisions on how much control each step gets

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Guides and checklists for MHRA GMP and GDP

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GxP toolkit

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Tips for passing your MHRA inspection

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Good distribution practice: understanding GDP compliance

Questions about MHRA GMP and GDP

What is the Orange Guide?

The MHRA's Rules and Guidance for Pharmaceutical Manufacturers and Distributors, named for its cover. It brings together the GMP guidelines for medicines and active substances, the GDP guidelines, the parts of the Human Medicines Regulations 2012 that apply to licence holders and the MHRA's own guidance. The latest print edition came out in 2022, with an online version kept up to date.

Is there an MHRA GMP certificate?

Yes. The MHRA issues a GMP certificate to a manufacturing site, or a GDP certificate to a wholesaler, after an inspection with a satisfactory outcome, and lists it in its GMDP database. No certification body is involved. The certificate is the regulator's, and the licence it supports is a separate grant.

Is UK GMP the same as EU GMP?

At the start, yes. The UK guidelines are the EU guide as it stood when the Brexit transition period ended, and changes since then apply in the UK only when the MHRA takes them up. A site supplying both markets reads both and keeps one set of procedures that answers each.

What does the MHRA expect on data integrity?

Its GxP data integrity guidance, published in March 2018, covers GMP, GLP and GCP records. It defines raw data, metadata and data governance, asks you to rate each record by how critical it is and how easily it could be compromised, and expects systems designed so the data stay complete and accurate for as long as they are kept.

Can we add MHRA GMP and GDP to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against its requirements, beside Eudralex Volume 4 or 21 CFR 211 if you run those too. The procedures written for Eudralex count towards the MHRA without being re-filed, and the first assessment lists what is covered and what is new.

When is your next MHRA inspection?

We will show you the MHRA's GMP and GDP requirements assessed against a set of procedures beside Eudralex, with the gaps listed and the evidence exported the way the inspector asks.

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