ICH Q7 is the international good manufacturing practice (GMP) guide for active pharmaceutical ingredients (APIs), from the defined API starting material through to release, storage and distribution. ICH adopted it at Step 4 on 10 November 2000 as Q7A, and 55 questions and answers followed on 10 June 2015.
This guide is for quality, production and regulatory staff at API manufacturers, contract manufacturers and API distributors.
What is ICH Q7, and is Q7A the same document?
Yes, Q7A and Q7 are the same guideline. ICH changed the code from Q7A to Q7 in November 2005 without changing the text. The PDF on ICH's quality guidelines page still carries the 2000 text as the current Step 4 version.
The 2015 questions and answers do not replace the guideline. They clarify sections that companies and inspectors had read in different ways. PIC/S collected many of the questions from its training sessions, and ICH's Q7 Implementation Working Group finalised them.
ICH Q7 is a guideline, not a certification standard. ICH does not certify anyone. Compliance is judged by regulators during GMP inspections and by customers during supplier audits. The Q&A also asks you to read Q7 together with ICH Q9 on quality risk management, Q10 on the pharmaceutical quality system and Q11 on development and manufacture of drug substances.
Where does ICH Q7 start to apply?
Q7 applies from the point where the API starting material enters the process. The company should designate that point and document why. Table 1 of the guideline shows the usual point for chemical synthesis, animal and plant extraction, herbal products, fermentation and cell culture.
GMP becomes stricter as the process moves from early steps to the final purification and packaging. Physical processing such as milling or micronising should meet at least the standard of the guide.
The starting material is normally defined in the regulatory filing and approved during review. Q&A 1.1 adds that steps before it are outside Q7, but they still need controls suited to making the starting material.
Some products are outside the scope. Q7 excludes vaccines, whole cells, whole blood and plasma, plasma derivatives and gene therapy APIs. It also excludes medical gases, bulk-packaged drug products and radiopharmaceutical-specific controls. For sterile APIs it stops just before the sterilisation step.
What do the 20 sections of ICH Q7 cover?
The guide has 20 numbered sections. Section 1 sets the scope and section 20 is the glossary. The table groups the rest and shows the records an inspector is likely to ask for. The right-hand column is AGS's interpretation, not ICH wording.
| Section | Topic | Records usually asked for |
|---|---|---|
| 2 | Quality management, quality unit, self-inspection, product quality review | Quality unit responsibilities, audit reports, annual product quality reviews with trends |
| 3 to 5 | Personnel, buildings, utilities, water, containment, equipment, calibration, computerised systems | Training records, water and environment results, calibration status, system validation files |
| 6 | Documentation and records | Master production instructions, batch production records, laboratory records, batch record review |
| 7 and 8 | Materials management, production and in-process controls | Supplier approvals, receipt and quarantine logs, yields, time limits, blending records |
| 9 and 10 | Packaging and labelling, storage and distribution | Label issue and reconciliation records, warehouse and distribution records |
| 11 | Laboratory controls, stability, retest dating, retention samples | Certificates of analysis, OOS investigations, stability protocols and data |
| 12 and 13 | Validation and change control | Validation policy, qualification and cleaning validation reports, change records |
| 14 and 15 | Rejection, reprocessing, reworking, returns, complaints and recalls | Reprocessing approvals, complaint files, recall records |
| 16 and 17 | Contract manufacturers and laboratories, agents, brokers, traders, distributors, repackers and relabellers | Quality agreements, contractor audits, traceability records |
| 18 and 19 | APIs made by cell culture or fermentation, APIs for clinical trials | Cell bank records, viral clearance data, clinical batch documentation |
What do inspectors look for in an API plant?
The Q&A shows where interpretation caused trouble, so it is a good guide to inspection focus. These are the points that most often change how a site works.
Quality unit independence comes first. The person who makes the final batch release decision should not hold production responsibilities. Other departments may release raw materials, but only inside a system the quality unit owns.
Product quality reviews are generally expected every year. The review is still needed when nothing was made in the period, and trend analysis is usually part of it.
Containment is risk-based. Penicillins and cephalosporins need dedicated production areas. For highly potent or toxic materials, the Q&A points to data such as permitted daily exposure and occupational exposure limits to decide containment.
Cleaning claims must be supported. "Visually clean" can be enough only for dedicated equipment and only with cleaning study data behind it.
Validation is flexible but evidence-led. A lifecycle approach to process validation is acceptable. A process parameter range cannot be widened on the strength of deviations alone.
How do the FDA, the EU and Gulf regulators apply ICH Q7?
Each regulator adopts Q7 through its own documents, so check the version your inspector uses.
In the United States, the FDA publishes Q7 as guidance for industry. The current version is dated September 2016, and the FDA added the Q&A as separate guidance in April 2018. Both are listed on the FDA guidance page.
In the EU, Q7 first appeared in November 2000 as Annex 18 of the GMP Guide. It is now Part II of EudraLex Volume 4, and the current revision came into operation on 1 September 2014. Part II adds a section on quality risk management that the ICH text does not have. PIC/S adopted the guide in 2001 and made it Part II of the PIC/S GMP Guide in 2007.
In the Gulf and wider region, ICH lists the SFDA (Saudi Arabia), JFDA (Jordan) and EDA (Egypt) among its regulatory members as of November 2025. ICH treats Q7 as a Tier 1 guideline that an authority must already have implemented when it applies for membership. The SFDA's GMP guide also refers to its own Part II for APIs.
Does ICH Q7 apply to API distributors and brokers?
Yes. Section 17 applies to every party in the supply chain between the original API maker and the drug product manufacturer, whatever the local name for the role. It covers traceability, quality management, repackaging and relabelling, stability, transfer of information, complaints, recalls and returns.
The line between trading and manufacturing is strict. Q&A 17.2 says a distributor that contracts out drying, milling, micronising or sieving becomes a manufacturer. If you outsource testing instead, section 16 on contract laboratories applies. Our ISO/IEC 17025 guide explains how testing laboratories show competence.
Finished dosage forms follow medicinal-product GMP rather than Q7. Our guide to pharmaceutical GMP for finished products covers that side, and the healthcare and pharmaceutical collection lists the related kits.
How AGS can help
The GMP Q7 Management System contains 75 editable Microsoft Word and Excel documents. It includes a GMP quality manual, 24 procedures and SOPs covering deviations, OOS results, change control, batch record review and release, stability and computerised system validation, and 30 forms. It also has 7 checklists, such as line clearance and batch record review, and an Excel compliance matrix that maps documents to ICH Q7 section numbers.
Frequently asked questions
Is ICH Q7 legally binding?
Q7 itself is a guideline. It gains force through national adoption. In the EU, for example, Directive 2001/83/EC requires manufacturing authorisation holders to use only active substances made under GMP.
Can a company be certified to ICH Q7?
No. ICH issues no certificates. Regulators inspect API sites, and customers audit their suppliers against Q7.
Do APIs made for clinical trials need full Q7 controls?
Not always. Section 19 accepts that some earlier controls do not fit a new API in development, but each batch still needs approval by an independent quality unit. Controls should match the development stage of the drug product.
Has ICH revised Q7 since 2000?
The guideline text has not changed since its Step 4 adoption. ICH added the questions and answers in 2015, and the code changed from Q7A to Q7 in 2005.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by ICH, the US FDA, the European Commission, PIC/S or the SFDA. They do not guarantee any inspection or audit outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
