ICH Q7 section 11.4 expects a certificate of analysis to name the material (with its grade where relevant), the batch number and the date of release; to carry the expiry or retest date; to list each test performed with its acceptance limit and the numerical result; and to be dated and signed by authorised quality-unit personnel, showing the name, address and telephone number of the original manufacturer. Where a repacker, reprocessor, agent or broker issues the certificate, the laboratory that did the testing and the original manufacturer must both be identified.
Where the requirement comes from
ICH Q7 is the harmonised good manufacturing practice guide for active pharmaceutical ingredients. It is adopted by the regulators of the ICH regions and referenced well beyond them, which makes its section 11.4, "Certificates of Analysis", the most widely shared statement of what an API certificate should carry.
The guide is written as expectations ("should") rather than as a form. That matters for anyone checking a certificate: the question is not whether the layout matches a template but whether each expected element is present, legible and consistent with the rest of the document.
The elements, one by one
Read together, paragraphs 11.40 to 11.44 of ICH Q7 describe the following content. The table gives the element, the paragraph it comes from and the practical point a reviewer looks for.
| Element | ICH Q7 | What a reviewer looks for |
|---|---|---|
| Issued for each batch, on request | 11.40 | The certificate refers to one batch. A certificate that covers several batches, or none, is not a batch certificate. |
| Name of the API, with grade where appropriate | 11.41 | The name on the certificate matches the material ordered, including the grade or pharmacopoeial designation. |
| Batch number | 11.41 | Present, and identical wherever it appears on the document and on the container label. |
| Date of release | 11.41 | A date on which the quality unit released the batch, distinct from the dates of testing. |
| Expiry date, or retest date | 11.41 | One of the two is present. An expiry date should be on the label and the certificate; a retest date on the label and/or the certificate. |
| Each test performed, in accordance with compendial or customer requirements | 11.42 | The list of tests matches the specification the material claims to meet. A claimed pharmacopoeial standard with tests missing is a gap. |
| Acceptance limits for each test | 11.42 | A limit is printed beside each test, not only a pass/fail word. |
| Numerical results where the test gives a number | 11.42 | A number, with its unit, rather than "complies" for a quantitative test. |
| Dated and signed by authorised personnel of the quality unit | 11.43 | A signature or approved electronic equivalent, a name or role, and a date. |
| Name, address and telephone number of the original manufacturer | 11.43 | Present and consistent with the manufacturing site named elsewhere. |
| Repacker or reprocessor identified, with reference to the original manufacturer | 11.43 | If someone other than the original manufacturer did the analysis, both parties are named. |
| Certificates issued by agents or brokers name the testing laboratory and attach the original certificate | 11.44 | A re-issued certificate carries the laboratory's name, address and telephone number, refers to the original manufacturer and batch certificate, and has a copy attached. |
What the guide does not say
ICH Q7 does not prescribe a layout, a language or a document number format, and it does not list the tests themselves; those come from the pharmacopoeial monograph or the agreed specification. It also says nothing about how the recipient should check the certificate, which is a matter for the recipient's own supplier qualification (see our article on relying on a supplier's certificate).
Nor does it address excipients. For excipients the closest equivalent expectations come from excipient GMP guidance and the IPEC certificate of analysis guide, which follow the same logic of identity, results against limits, dates and an authorised signature.
Gaps that turn up often
Across supplier certificates the same omissions recur, and each one maps to a paragraph above.
- No certificate or document number and no issue or release date, so the document cannot be referred to unambiguously (11.41, 11.43).
- "Complies" printed against a quantitative test such as assay or loss on drying, where a number is expected (11.42).
- A printed limit that is wider than the limit in the pharmacopoeial monograph the certificate claims to follow (11.42).
- A signature block with titles but no names, or no date beside the signature (11.43).
- The issuer's name appears only in a logo, with no address or telephone number in the text (11.43).
- A trader's certificate that does not say which laboratory performed the analysis and does not attach the manufacturer's original (11.44).
Definitions
- Certificate of analysis (COA, CoA)
- A document issued for a batch of material that lists the tests performed, the acceptance limits and the results, and is authorised by the issuer's quality unit.
- Quality unit
- In ICH Q7, the organisational unit (or units) independent of production that fulfils quality assurance and quality control responsibilities, including release.
- Retest date
- In ICH Q7's glossary, the date when a material should be re-examined to ensure that it is still suitable for use.
Sources
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Step 4, 10 November 2000), International Council for Harmonisation (sections 11.40 to 11.44, 11.61, and the glossary)
Primary sources are cited in preference to summaries. Where a source is licensed (for example a pharmacopoeial monograph) the reference is given and the text is not reproduced.