Guide ยท Documents
CoA required fields: what a usable certificate carries
- Short answer
- No single list of required fields applies everywhere, but a usable CoA typically carries the product and grade, the batch or lot number, the relevant dates, a table of tests with method, specification and result for each, the issuer's identity, and a named approver with a date. Your specification and supplier agreement can add to this.
General background, not regulatory or GMP advice. Which fields you must have is set by your specification, your supplier agreement and the rules that apply to you.
Where the list comes from
Three sources decide what a certificate must carry. Your own specification and supplier agreement say what you will accept. Sector guidance may add to it: for active pharmaceutical ingredients, ICH Q7 describes the content of a certificate, including the name and grade, the batch number, the release date and the expiry or retest date, each test with its acceptance limits and numerical results, and a dated signature from authorised quality-unit personnel with the original manufacturer's name and address.
Good practice fills the rest: a certificate a stranger could use without phoning the supplier. A certificate that is not a CoA at all is covered in CoA vs certificate of conformance. If a field is missing, treat it as a gap to raise, not a detail to fill in by hand.
Checking a certificate for completeness
Six checks that take a minute and catch most unusable documents.
Identity block
Product name, grade and code agree with the order. The grade matters: food, technical and pharmacopoeial grades of one substance can have different specifications.
Batch or lot number
Present, legible and identical to the label and the delivery note. See batch and lot numbers.
Dates
A manufacture date and an expiry or retest date, each with its label, plus sampling, analysis and issue dates where printed. They should be in a plausible order and unambiguous. See retest date vs expiry date.
Test table
Every test your specification requires, each with a method reference, a specification, a result and a unit. A row missing any of these is a row you cannot fully check.
Issuer and approval
The manufacturer or laboratory with its address, and a named approver or an authorised-signature statement with a date. A distributor's re-issued certificate should name the original manufacturer and batch.
Document control
A certificate number, page numbers such as 1 of 2, and a specification reference or revision, so you know nothing was dropped and which limits applied.
Field by field
What to look for, and the gap that usually appears.
| Field | What to look for | Typical gap |
|---|---|---|
| Product, grade, code | Matches the order; grade stated | Trade name only; grade missing |
| Batch or lot | Same characters as the label | Distributor lot with no manufacturer reference |
| Manufacture date | Present, in a clear format | Only an undated 'issue' date |
| Expiry or retest date | Labelled as one or the other | Neither shown; shelf life given in months only |
| Sampling and analysis dates | Printed, and in a plausible order | Analysis dated after release, or no dates at all |
| Tests | Name, method, specification, result and unit on each row | Result without a limit, or a limit without a unit |
| Methods | A compendial reference or an in-house code | Column absent, or 'per supplier' |
| Conclusion | Names the specification the lot was assessed against | 'Meets specification' with no reference |
| Issuer and approval | Name, role, date and manufacturer address | 'Valid without signature' and no named person |
| Document control | Certificate number, page count, revision | No page count; specification revision not given |
What goes wrong with incomplete certificates
- Results without limits. A result only means something against the limit and unit printed beside it. Without them the row is a number with no verdict.
- One date, three meanings. A single unlabelled date could be manufacture, analysis or issue. Ask rather than assume.
- Ambiguous date formats. 03/04/2026 is March or April depending on the country of the issuer.
- A re-issued CoA that drops its source. A distributor's certificate with no reference to the manufacturer or the original batch breaks the chain back to the laboratory that tested the lot.
- Typical values presented as results. Columns headed typical or average describe a product, not this lot.
- Unsigned and unnamed. Computer-generated certificates can be legitimate, but check your agreement for who must stand behind the document.
How CertiClean helps
CertiClean reads the header fields it finds by their labels (product, product code, batch or lot, manufacture date, expiry or retest date, supplier, CoA number, sampling date and issuer) and one row per test with specification, method, result and unit. When no lot is found, a note says so. It cannot confirm that a field is genuine or that a signature is real, and it does not know which fields your quality system requires. See CoA to Excel and pricing.
Free allowance: 1 file per day, up to 10 pages, no account.
Questions people ask
Is there an official list of CoA fields?
No single list applies to every material and market. Guidance such as ICH Q7 describes certificate content for active pharmaceutical ingredients, and buyers add their own requirements in specifications and supplier agreements.
Does a CoA need a signature?
It depends on your agreement and sector rules. Many certificates are computer generated and say they are valid without a signature. Check whether your quality system needs a named approver.
Which date matters most on a CoA?
The expiry or retest date decides how long the lot stays usable, and the manufacture date anchors it. Sampling and analysis dates help you judge how current the results are.
Should a CoA show the test method?
Typically yes. A method reference lets you compare lots and suppliers and see when a method changed. If the column is absent, ask the supplier for method references.
What if the CoA comes from a distributor?
It should identify the original manufacturer and the original batch. Guidance for active ingredients expects a re-issued certificate to refer back to the original batch certificate.
Do I need the specification revision?
It helps. Limits change between revisions, and without the reference you cannot tell which limits the lot was assessed against.
What does 'typical' mean on a certificate?
A typical or average value describes the product in general. It is not a result for your lot and cannot support a release decision on its own.
What should I do if a field is missing?
Record the gap, ask the supplier for a corrected or complete certificate, and follow your procedure for the lot meanwhile. Do not fill in missing details by hand.