ICH Q7: what it is, who needs to comply, and where GMP starts for an API

What is ICH Q7?

ICH Q7 is the International Council for Harmonisation's good manufacturing practice guideline for active pharmaceutical ingredients. It covers the API from the step where the API starting material enters the process to the final purified ingredient. The FDA, the EU and the other ICH regions adopted it, so an API site is inspected against it. There is no Q7 certificate.

It reached ICH Step 4 in November 2000, the FDA published it as guidance in 2001 and the European Commission adopted it as Part II of Eudralex Volume 4. The controls tighten as the process moves from the starting material toward the final API. Its sections cover quality management, personnel, buildings, equipment, documentation, materials, manufacturing and in-process controls, packaging, storage and distribution, laboratory controls, validation, change control, rejection and re-use, complaints and recalls, contract manufacturers, agents and brokers, cell culture and fermentation, and APIs for clinical trials.

Who needs to comply with ICH Q7?

Manufacturers of an active pharmaceutical ingredient or an intermediate for the US, the EU, Japan or any other ICH or PIC/S market, from the API starting material onward

Contract manufacturers and laboratories that perform a step on someone else's API, and the agents, brokers, traders, repackers and relabellers who handle it afterwards, since sections 16 and 17 give each its own obligations

Biotech companies making an API by cell culture or fermentation, and sponsors making an API for clinical trials, where sections 18 and 19 apply the guideline in step with the process and the phase

The guideline becomes urgent when an EU importer asks for the written confirmation of GMP, when a customer's quality agreement says which sections of Q7 are yours, or when an inspector asks at which step the API starting material enters and GMP begins.

ICH Q7 IN QUALIO

Qualio assesses the same records against Q7 beside cGMP, so an API site answers both on the procedures it already has

Qualio breaks Q7 down section by section, beside cGMP and Eudralex in the same library, and maps your procedures, training records, deviations, change controls and supplier files to the sections they answer. When a record changes, it reassesses those sections and recommends a fix for each gap. Copilot drafts the deviation write-up from it, and your team approves it. When the inspector asks, you export the evidence by section.

A change to a process, a specification or a supplier routed to the approvers your procedure names, with the documents it touches linked before anyone signs, for section 13

Suppliers of critical materials and contract manufacturers qualified once, with an audit schedule set by risk and every deviation linked to the supplier behind it, for sections 7 and 16

A revised procedure effective on the date you set, with the retraining out that day to everyone who follows it and the training record kept against the procedure, for section 3

Standards that apply alongside ICH Q7

Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's regulation for finished pharmaceuticals, which stops at the drug product, so a US API site is inspected against Q7 as the measure of the statutory GMP requirement
Pharma manufacturingEU GMP, Eudralex Volume 4: Part I covers the medicinal product and Part II is Q7's text, so an EU inspector reads an active substance manufacturer against the same sections
Pharma manufacturingICH Q10: The pharmaceutical quality system model Q7's quality management section is read through, adding management review and a product lifecycle the guideline does not ask for by name
Pharma manufacturingICH Q11: Development and manufacture of drug substances, including how the API starting material is proposed and justified, which is the point where Q7's GMP begins
Pharma manufacturingICH Q9: Quality risk management, applied under Q7 to decide how much control each step gets as the process moves from the starting material toward the final API

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Guides and checklists for ICH Q7

Toolkit

GxP toolkit

Blog

The complete guide to the ICH Q7 guidelines

Toolkit

ICH Q10 toolkit

Questions about ICH Q7

What is ICH Q7?

ICH Q7 is the International Council for Harmonisation's good manufacturing practice guideline for active pharmaceutical ingredients. It sets the expectations for quality management, materials, manufacturing, laboratory controls and change control from the API starting material to the final ingredient. The FDA, the EU and the other ICH regions adopted it, and inspectors read an API site against it.

Where does GMP start in API manufacturing?

At the API starting material. Q7 defines it as a raw material, intermediate or API that is used to make an API and is incorporated as a significant structural fragment into its structure. The manufacturer proposes and justifies it under ICH Q11, GMP applies from the step that introduces it, and the controls tighten from there to the final API.

What is the difference between ICH Q7 and 21 CFR Part 211?

Part 211 is the FDA's regulation for finished pharmaceuticals and does not cover the API. An API manufacturer in the United States is bound by the statutory GMP requirement in the Food, Drug, and Cosmetic Act, and the FDA uses Q7 as its guidance on what that requirement means for an API site, so investigators inspect against Q7's sections.

Is ICH Q7 mandatory?

Q7 is a guideline, and GMP for an API is the law in every ICH region. In the EU it is Part II of the GMP guide, so an active substance manufacturer is inspected against it and the national agency issues a GMP certificate afterwards. In the US the FDA inspects against it as the measure of the statutory requirement.

Can we add ICH Q7 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every section, beside cGMP or Eudralex if you run those too. The deviations, change controls and supplier files that answer the finished-product regulations count towards Q7 without being re-filed, and the first assessment lists what is covered and what is new.

Where does GMP start in your process?

Bring your process map and your procedures. We will show you Q7 assessed against them section by section, with the gaps listed and the evidence exported the way an inspector asks.

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