ICH Q7: GMP for active ingredients, from the starting material on
Q7 starts where your starting material enters the process, and gets stricter toward the final API. The quality unit stays independent all the way.
In Short
- You define and justify where GMP starts.
- Watch the impurity profile for drift.
- Reprocessing repeats a step; reworking needs evaluation first.
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
- Who decides, and who may not
- Supplier to finished bulk
- Test, review, investigate
- Packs, serialisation and recall
Plus Evidence map and four worksheets.
Get the pharmaceutical guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
ICH Q7 is the internationally harmonised GMP guideline for active pharmaceutical ingredients (APIs). FDA publishes it as final guidance (the version on FDA's site is dated September 2016); in the EU it is Part II of the GMP Guide. It is guidance, but regulators inspect API makers against it. This guide covers the questions API quality and production leads ask most. Checked against FDA's ICH Q7 guidance page on 2 Oct 2026.
Where GMP starts
Q7 applies from the point the API starting material enters the process, with GMP expectations increasing as the process moves toward the final API. The applicant defines and justifies the starting material.
GMP Increases Toward the Final API
| Stage | Typical expectation |
|---|---|
| Before the starting material | Outside Q7; supplier knowledge still matters |
| Starting material introduced | GMP applies from here |
| Intermediates | Increasing control of process and records |
| Isolation and purification | Tighter control, impurity profile monitored |
| Physical processing and packaging | Highest level of GMP |
- Before the starting material
- Typical expectation
- Outside Q7; supplier knowledge still matters
- Starting material introduced
- Typical expectation
- GMP applies from here
- Intermediates
- Typical expectation
- Increasing control of process and records
- Isolation and purification
- Typical expectation
- Tighter control, impurity profile monitored
- Physical processing and packaging
- Typical expectation
- Highest level of GMP
More on where GMP starts
Steps before it are outside Q7's scope, though you still need to know your supplier.
An Independent Quality Unit
Q7 expects one or more quality units, independent of production, that approve or reject APIs, intermediates and materials, review batch records, and make sure critical deviations are investigated.
Impurity Profiles and Specifications
Q7 expects an impurity profile for each API, compared at intervals with the profile in the regulatory submission or historical data. Changes in the profile can be a sign that the process or raw materials have shifted, so they are investigated, not just recorded.
Reprocessing and Reworking
Reprocessing repeats an established step of the process and is normally acceptable when it is part of the process. Reworking uses a different process and needs evaluation, and often a change record.
Reprocess or rework?
Pick a situation.
- Repeats an established process step. Record it; investigate if frequent.
More on reprocessing and Reworking
Material that is reprocessed or reworked should be investigated if it happens repeatedly.
Records and who decides
Batch production records should be reviewed and approved by the quality unit before release. Laboratory records keep complete data, including failures.
More on records and who decides
Software can hold master instructions, batch records, lab results and deviations together. The quality unit decides release.
Questions
Is ICH Q7 legally binding?
Q7 itself is guidance. In the US, FDA publishes it as guidance for industry and inspects API makers against CGMP using it. In the EU it forms Part II of the GMP Guide, which inspectors use to judge compliance.
What is the difference between reprocessing and reworking?
Reprocessing repeats a step that is already part of the established process. Reworking uses a different process step and needs evaluation and appropriate documentation before it is used.
Who releases an API under Q7?
The quality unit, which must be independent of production, approves or rejects APIs.
Does V5 release APIs?
No. V5 keeps master and batch records, deviations, CAPA, laboratory results and electronic signatures. Your quality unit reviews the record and decides release.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Australia Pharmaceutical GMP Readiness: TGA and PIC/S GMP
Brazil Pharmaceutical GMP Readiness: ANVISA RDC 658/2022
Canada Drug GMP Readiness: Food and Drug Regulations Part C, Division 2
US Cannabis State GMP Readiness for Multi-State Operators
China Pharmaceutical GMP Readiness: NMPA and China GMP
EU GMP Annex 1 Guide: Contamination Control Strategy, APS and PUPSIT