1What ICH Q7 is, and what it covers.
ICH Q7, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, reached Step 4 of the ICH process on 10 November 2000. It was first coded Q7A and recoded Q7 in November 2005.¹ Its purpose is GMP for manufacturing APIs “under an appropriate system for managing quality”, and helping APIs meet the quality and purity they are represented to possess. Manufacturing means every operation from receipt of materials through production, packaging, labelling, quality control, release, storage and distribution. “Should” marks recommendations expected to apply unless shown to be inapplicable or replaced by an alternative giving at least equivalent quality assurance, and Q7 treats “current good manufacturing practices” and “good manufacturing practices” as equivalent.¹
Q7 applies to APIs for human drug products made by chemical synthesis, extraction, cell culture or fermentation, recovery from natural sources, or a combination of these; section 18 adds guidance for cell culture and fermentation.¹ Sterile APIs are covered only up to the point immediately before they are rendered sterile. Q7 excludes vaccines, whole cells, whole blood and plasma, plasma derivatives and gene therapy APIs, and does not apply to medical gases, bulk-packaged drug products or radiopharmaceutical-
2Where GMP starts: the API starting material.
An API starting material is 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 company should designate and document the rationale for the point at which API production begins; for synthetic processes, it is where API starting materials enter the process. Q7’s Table 1 shows the usual point for chemical, animal-derived, plant-derived, herbal and biotechnology processes.¹
From that point, GMP stringency should increase from early steps to final steps, purification and packaging, and physical processing such as granulation, milling or micronising should meet at least Q7’s standards.¹ Q7 does not apply before the starting material, but the Q7 questions and answers still expect “an appropriate level of controls” there, and note that the starting material is normally defined in the regulatory filing and approved in review.²
3What it expects, section by section.
| Section | Key expectations |
|---|---|
| 2 Quality management | A quality unit independent of production, with both QA and QC responsibilities. Its main responsibilities should not be delegated: releasing or rejecting APIs, reviewing batch and laboratory records of critical steps, making sure critical deviations are investigated, and approving specifications, changes and contract manufacturers. Regular internal audits and an annual product quality review.¹ |
| 6 Documentation and records | Master production instructions, batch production and laboratory control records, and review of batch records.¹ |
| 7 Materials management | At least one identity test on each batch of incoming material. A supplier’s certificate of analysis can replace other tests if the manufacturer has a system to evaluate suppliers, with full analysis of at least three batches before reducing in-house testing.¹ |
| 11 Laboratory controls | Testing of intermediates and APIs, certificates of analysis, stability monitoring, expiry and retest dating, and reserve samples.¹ |
| 12 Validation | Prospective validation is preferred. Concurrent and retrospective validation are allowed in defined cases, alongside cleaning and analytical method validation.¹ |
| 13 Change control | A formal system to evaluate all changes that may affect production and control, approved by the quality unit, with the first batches after a change evaluated and drug product manufacturers notified of changes that can affect API quality.¹ |
| 16 Contract manufacturers | Evaluation by the contract giver, a written agreement defining each party’s GMP responsibilities, the right to audit, and approval of subcontracting and changes.¹ |
| 17 Agents, brokers and distributors | GMP compliance, and complete traceability back to the original manufacturer.¹ |
| 19 APIs for clinical trials | Controls consistent with the stage of development of the drug product.¹ |
4How ICH Q7 applies in the US and the EU.
In the US, a drug is adulterated under section 501(a)(2)(B) of the FD&C Act if the methods, facilities or controls used to make it do not conform to current good manufacturing practice,³ and FDA applies that to active pharmaceutical ingredients.⁴ The CGMP regulations in 21 CFR Parts 210 and 211 cover finished pharmaceuticals; for API manufacture FDA points to ICH Q7, which it publishes as final guidance dated September 2016.⁵⁶
In the EU, Q7 was published in November 2000 as Annex 18 to the GMP Guide, and became Part II of EudraLex Volume 4, Basic Requirements for Active Substances used as Starting Materials. The current revision came into operation on 1 September 2014.⁷⁸ Article 46(f) of Directive 2001/83/EC obliges manufacturing authorisation holders to use only active substances made in accordance with GMP.⁷ Part II adds a section on quality risk management that Q7 itself does not have.⁷¹
Commission Delegated Regulation (EU) No 1252/2014, which applies from 25 May 2015, puts the GMP principles for active substances into a legally binding act, in line with the ICH guidelines. It requires a quality system that incorporates quality risk management, a quality unit independent of production, and regular internal audits with follow-up.⁹ Active substance manufacturers and importers supplying the EU must register with their national competent authority, and each imported consignment needs a confirmation from the authority of the country where it was produced that it meets GMP standards equivalent to the EU’s, unless a waiver applies.¹⁰
5The Q7 questions and answers.
ICH published questions and answers on Q7 on 10 June 2015, with contributions from PIC/S.² They clarify, for example, that the person in the quality unit responsible for final decisions such as batch release should have no production responsibilities; that Q7 does not prescribe who performs API release testing; and that other departments may release raw materials under a system the quality unit establishes and oversees.² They also say Q7 should be applied together with ICH Q11 on drug substance development and manufacture, Q9 on quality risk management and Q10 on the pharmaceutical quality system.²
6How it runs in Seal.
Seal’s API manufacturing blueprint keeps the genealogy from raw-material lots through intermediates to released containers, and every step in it carries the operation, equipment, quantities, conditions, samples, results and approval that produced the next state. At charging, Seal verifies the source container’s identity, status, allowed lot, retest date and remaining quantity. Reprocessing is a controlled branch, repackaging or relabelling creates new genealogy rather than overwriting the original container, and a trace runs backward from a final container to its supplier lots or forward from a raw-material lot to every lot that consumed it.
A trend across batches can start change control, CAPA or validation work without silently changing the instructions active batches are using. Pharmaceutical manufacturing connects materials, batch execution, equipment state, QC testing, deviations, labels and disposition around shared products and batches, and deviations, CAPA, change control, audits and suppliers run in the QMS.
References
- 1ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH, 10 November 2000. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 2ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Questions and Answers, ICH, 10 June 2015. https:/
/ database. ich. org/ sites/ default/ files/ Q7_ Q%26As_ Q%26As. pdf (read 6 November 2026) - 321 U.S.C. 351, Adulterated drugs and devices (FD&C Act section 501), United States Code, 2023 edition, govinfo. https:/
/ www. govinfo. gov/ content/ pkg/ USCODE- 2023- title21/ html/ USCODE- 2023- title21- chap9- subchapV- partA- sec351. htm (read 6 November 2026) - 4Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, draft guidance for industry, FDA, March 2026, footnote 8. https:/
/ www. fda. gov/ regulatory- information/ search- fda- guidance- documents/ responding- fda- form- 483- observations- conclusion- drug- cgmp- inspection (read 6 November 2026) - 5Overview of Drug Manufacturing Inspections, Understanding FDA Inspections and Data webinar, FDA, 6 September 2023. https:/
/ www. fda. gov/ media/ 172786/ download (read 6 November 2026) - 6Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry, FDA, September 2016. https:/
/ www. fda. gov/ regulatory- information/ search- fda- guidance- documents/ q7- good- manufacturing- practice- guidance- active- pharmaceutical- ingredients- guidance- industry (read 6 November 2026) - 7EudraLex Volume 4, Part II: Basic Requirements for Active Substances used as Starting Materials, European Commission, 13 August 2014. https:/
/ health. ec. europa. eu/ document/ download/ bd537ccf- 9271- 4230- bca1- 2d8cb655fd83_ en?filename=2014- 08_ gmp_ part1. pdf (read 6 November 2026) - 8EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission. https:/
/ health. ec. europa. eu/ medicinal- products/ eudralex/ eudralex- volume- 4_ en (read 6 November 2026) - 9Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 on principles and guidelines of good manufacturing practice for active substances for medicinal products for human use, EUR-Lex. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:32014R1252 (read 6 November 2026) - 10Good manufacturing practice, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice (read 6 November 2026)
AQuestions and answers
What is the difference between ICH Q7 and 21 CFR Part 211?
Part 211 is a US regulation setting CGMP for finished pharmaceuticals. ICH Q7 is harmonised guidance for active pharmaceutical ingredients. API manufacturers supplying the US must still make their APIs under CGMP, as the FD&C Act requires, and FDA uses Q7 as its guidance on what that means.
Is ICH Q7 the same as EU GMP Part II?
Very nearly. Part II of EudraLex Volume 4 was built from the text of Q7, first published in the EU as Annex 18, and follows the same structure, with additions such as a section on quality risk management. The legal requirements behind it are in Directive 2001/83/EC and Delegated Regulation (EU) No 1252/2014.
Does ICH Q7 apply to biologics and cell and gene therapies?
It covers APIs made by cell culture or fermentation, with specific guidance in section 18. It excludes vaccines, whole cells, whole blood and plasma, plasma derivatives and gene therapy APIs.
Does ICH Q7 apply to APIs used in clinical trials?
Section 19 covers them. Controls should be consistent with the stage of development, and procedures can stay flexible as knowledge grows, but APIs for clinical trial products must still be made in suitable facilities with appropriate production and control procedures. In the EU, Part II says applying section 19 is recommended but not required by EU legislation.
What is the difference between ICH Q7A and ICH Q7?
They are the same guideline. It was finalised as Q7A in November 2000 and recoded Q7 in November 2005; the current version is still the one dated 10 November 2000.
Can an API manufacturer rely on a supplier’s certificate of analysis?
Partly. Q7 expects at least one identity test on every incoming batch. A supplier’s certificate can replace the other tests if the manufacturer evaluates its suppliers, has done full analysis on at least three batches, repeats full analysis at intervals and checks the certificates’ reliability regularly.