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ICH Q7 API GMP audit checklist

Practising auditors wrote these 350 audit questions, covering the full standard. Each item names the objective evidence to request, the nonconformities most often raised against it, and what to sample. It is free to read, with no sign-up required.

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350 items29 hours estimated, end to end 18 sectionsICH Q7 · updated 2026-06-22

What each item gives you

This is what an auditor needs at each item. You already hold the standard itself.

The question

Phrases it the way you would ask it in the room.

Objective evidence

Names the specific artefacts that satisfy the item, and how to tell a real one from a placeholder.

Common nonconformities

Lists the findings most often raised here, in the words they get written up in.

Auditor tips

Shows where the item usually goes wrong, and what a mature answer sounds like against a rehearsed one.

What to sample

Explains how many to take, how to choose them, and what to cross-reference them against.

Follow-up questions

Gives the second and third questions to ask when the first answer is too smooth.

All 350 items across 18 clauses

This checklist runs to 350 items, so each top-level clause has its own page rather than one document you have to scroll. Items are there in full, with its objective evidence, common nonconformities and auditor tips — nothing is held back for the PDF.

Clause 2 Quality management 17 items · 1 section Clause 3 Personnel 10 items · 1 section Clause 4 Buildings and facilities 26 items · 1 section Clause 5 Process equipment 30 items · 1 section Clause 6 Documentation and records 24 items · 1 section Clause 7 Materials management 22 items · 1 section Clause 8 Production and in-process controls 28 items · 1 section Clause 9 Packaging and identification labelling of APIs and intermediates 20 items · 1 section Clause 10 Storage and distribution 7 items · 1 section Clause 11 Laboratory controls 33 items · 1 section Clause 12 Validation 30 items · 1 section Clause 13 Change control 8 items · 1 section Clause 14 Rejection and re-use of materials 13 items · 1 section Clause 15 Complaints and recalls 6 items · 1 section Clause 16 Contract manufacturers (including laboratories) 7 items · 1 section Clause 17 Agents, brokers, traders, distributors, repackers, and relabellers 15 items · 1 section Clause 18 Specific guidance for APIs manufactured by cell culture/fermentation 31 items · 1 section Clause 19 APIs for use in clinical trials 23 items · 1 section

Each item shows its evidence, common nonconformities and auditor tips. The PDF above holds the same content, all 350 items, formatted for a clipboard.

Frequently Asked Questions

What is ICH Q7?

ICH Q7 is the ICH Good Manufacturing Practice guide for Active Pharmaceutical Ingredients (APIs). It defines GMP expectations for manufacturing APIs used in human drug products, covering quality management, personnel, buildings and facilities, equipment, documentation, materials management, production and in-process controls, packaging and labelling, laboratory controls, validation, change control, and the handling of complaints and recalls. It has been adopted globally — for example as FDA guidance and as EU GMP Part II.

Does ICH Q7 apply to API intermediates?

Yes, but the level of GMP increases as the process moves toward the final API. ICH Q7 introduces the concept of an 'API starting material' and expects GMP controls to be applied from the point that material enters the process, becoming progressively more rigorous through to final isolation and purification. Early steps may have appropriate, lighter controls; the final steps are held to full GMP.

How is ICH Q7 different from EU GMP Part II?

They are essentially the same text — EU GMP Part II is ICH Q7 adopted into the European GMP framework, and FDA likewise issues ICH Q7 as guidance. An organisation that meets ICH Q7 is therefore meeting the API GMP expectations of the major regulators. The practical differences lie in how each authority inspects and enforces, not in the underlying requirements.

What does 'should' mean in ICH Q7?

ICH Q7 uses 'should' rather than 'shall' or 'must'. In ICH guidance, 'should' indicates a recommendation or expectation — not necessarily the only acceptable approach, but the expected one unless a justified, science-based alternative achieves the same outcome. In practice it is not optional: auditors expect either conformance or a documented rationale for any deviation.

What are common ICH Q7 audit findings?

Frequent findings include weak change control and incomplete process validation, data-integrity gaps in laboratory and batch records, unjustified designation of the API starting material, deficient qualification of suppliers and contract manufacturers, incomplete cleaning validation, and poor handling of deviations, out-of-specification results, and recalls. The independence and authority of the quality unit — particularly over batch release — is a recurring focus area.

Checklists for the other standards

ISO 9001:2015gap analysis · 251 items AS9100Daerospace · audit FDA QMSR21 CFR 820 transition EU MDR2017/745 compliance
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