Documentation

The certificate of analysis, in detail

A certificate of analysis lists the tests performed on one defined sample, the acceptance criteria applied and the results obtained, followed by a statement of whether the sample complies with the specification. One certificate covers one batch: a certificate cannot be extended to a later batch, a repacked presentation or a different pack size, and a partner holding a certificate for batch A has no document covering batch B. The certificate reports testing; it makes no statement about a product's regulatory status anywhere, and it is not evidence of approval, registration or inspection. Our certificates follow the WHO model certificate of analysis published in WHO Technical Report Series No. 1010, Annex 4 (2018), which superseded the 2002 model in TRS 902, Annex 10, and which draws its item list from WHO good practices for pharmaceutical quality control laboratories, WHO GMP and ISO/IEC 17025. The WHO text is explicit that the model is an example and not prescriptive, and that format and layout are at the issuing laboratory's discretion. A related but different document is the manufacturer's batch certificate at Appendix 2 of WHO TRS 1033, Annex 9 — it appends the certificate of analysis and adds the marketing-authorisation and shelf-life fields the importing side needs; those authorisation fields are completed by the local licence holder, not by us.

WHO model certificate of analysis — the field set (TRS 1010, Annex 4, Appendix 1)

Certificate identification

Identification number of the certificate, repeated on every page together with page X of Y, so that no page can be detached and read as though it were the whole document.

Issuing laboratory

Name and address of the laboratory issuing the certificate. For Ergopharm batches this is the site quality control laboratory; the certificate may be printed on the issuing laboratory's letterhead.

Originator of the request

Name, address and contact person representing the party that requested the analysis.

Sample registration

The number assigned to the sample on receipt, the date received and the quantity received in units or packages.

Product name

International Nonproprietary Name or generic name, together with the brand name under which the product is supplied.

Dosage form, strength, pack size

For example: solution for injection, 250 mg/ml, 1 ml ampoule, 10 ampoules per carton; or film-coated tablet, 10 mg, 30 tablets per carton.

Container description

Type and material of the primary packaging — Type I amber glass ampoule with one-point-cut opening, or PVC/PVdC–aluminium blister — since the container is part of what was tested.

Batch number

The batch number used by the original manufacturer, plus the number used by a repacker or trader where one is involved.

Batch size

Stated by Ergopharm in addition to the WHO model item list: the number of units filled or packed in the batch, so that the certificate can be reconciled against the packing list and the serialisation event data.

Date of manufacture and expiry

Date of manufacture where available, and the expiry date or, for a starting material, the retest date.

Original manufacturer

Name, address, telephone and email of the original manufacturer; where the product passed through a repacker or trader, that party's details as well.

Storage and transport conditions

Where the certificate is used in trade, WHO allows a statement of the expected conditions for shipping, packaging, storage and distribution, deviation from which invalidates the certificate. Ergopharm always includes it, worded to match the labelled storage statement.

Specification reference and version

The specification applied for testing, cited by its controlled document number and version, together with a reference to the test procedures used and their acceptance criteria.

Test table

One row per test, with four columns: test, method reference (a pharmacopoeial chapter or an in-house technique), acceptance criteria, and result. Results are given in numerical form wherever applicable, and any test performed by a subcontractor is identified as such.

Comments and additional information

Observations or specific test conditions needed to interpret a result, plus anything the customer has requested be specified. A statement of measurement uncertainty is included where it is relevant to the validity of the result — noting that pharmacopoeial content limits are already set with uncertainty and production capability in mind.

Conclusion

An explicit statement as to whether or not the sample was found to be within the limits of the specification. A certificate without this conclusion is incomplete.

Authorised person and date of issue

Name and job title of the head of laboratory or other person authorised to approve the certificate, with telephone and email, signature, and the date of issue. On Ergopharm certificates this signature is the quality control approval; batch release itself is a separate decision recorded in the batch record.

Requesting a certificate for a specific batch

Because a certificate is batch-scoped, the request must be batch-scoped. Send the product name and pack format, the batch number exactly as printed on the carton and the ampoule or blister, the expiry date, and the consignment or invoice reference under which the batch reached you. The batch number and expiry are also encoded in the GS1 DataMatrix on every carton under Application Identifiers 10 and 17, so a scan resolves them if the printed text is damaged. We check the request against the despatch record for that consignment before issuing; where a batch number does not match a consignment released to the requesting party, we do not issue a certificate and we raise the discrepancy with quality assurance. A certificate travels with each despatch by default, so most requests are re-issues — a replacement copy, a certified hard copy, or a copy addressed to a customs broker or a tender authority named by the partner. Re-issues carry a new issue reference and the same batch data; they never supersede or amend the original result. If a partner needs a certificate for a batch tested by their own laboratory as well, that is a confirmatory test report on their letterhead, not a re-issue of ours, and any discrepancy between the two is handled as an out-of-specification investigation under the quality agreement.

Who issues what — correcting a common overclaim

Manufacturers are routinely described, in tender documents and on supplier websites, as holding or issuing a CoPP. That is not how the instrument works, and the wording matters. The certificate of a pharmaceutical product is the primary document of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce — a voluntary agreement between participating Member States and regional authorities, in operation since 1969 and currently set out in WHO Technical Report Series No. 1033, Annex 9 (2021). Under the Scheme, a certifying authority attests to a requesting authority in another participating territory that a specific product is authorised on its own market (or why it is not), that the manufacturing site is inspected at suitable intervals against GMP as recommended by WHO, what the product's actual commercialisation status is, and that the submitted product information including labelling is currently authorised. The certificate is issued by that authority, upon application by a commercially interested party, and only with the permission of the applicant or the marketing-authorisation holder; it is confidential, it is prepared for a single product and dosage form, and a copy with any section deleted is no longer a CoPP. A manufacturer is an applicant and a source of data — never an issuer. Ergopharm's role is to compile the dossier and quality documentation that supports a partner's application, and to provide its own manufacturing and quality records; the decision, the wording and the timing rest entirely with the issuing authority.

Certificate, issuer, purpose, and our role

Certificate of a pharmaceutical product (CoPP / CPP)

Issued by a national or regional certifying authority of the exporting territory, in the format recommended by WHO. Purpose: to be incorporated into a partner's marketing-authorisation application in the importing market, or into the renewal, extension or review of one. It covers product name and composition, authorisation status, the manufacturing sites and their activities, inspection arrangements and conformity with GMP as recommended by WHO. Our role: assemble the manufacturing, composition, packaging and product-information data the applicant submits, and answer the authority's follow-up questions through the applicant.

Manufacturer's batch certificate

Appendix 2 of the same WHO annex, normally issued by the manufacturer for a batch of a product already authorised in the importing market. It states batch number, date of manufacture, shelf life, container and closure, storage conditions and temperature range, the applicable specification, whether the batch complies, and appends the certificate of analysis. Our role: we issue it; the marketing-authorisation fields are completed by the local licence holder.

Official batch release certificate

Issued by a competent authority or an official control laboratory, and applied on an exceptional basis — in practice almost exclusively to biological products such as vaccines and plasma derivatives. Not applicable to our dosage forms, and not something a manufacturer issues.

Free sale certificate

Issued by an authority of the exporting country (in some jurisdictions, and for non-medicinal goods, by a chamber of commerce). It attests only that the product may be freely sold in that country — it says nothing about GMP status or about the manufacturing site. Where a CoPP is available, most importing authorities now ask for the CoPP instead, and the free sale certificate survives mainly as a customs or tender formality. Our role: application support only.

GMP certificate and manufacturing licence

Documents of the licensing authority of the manufacturing territory, granted on the basis of inspection and held on that authority's own register. WHO issues no GMP certificate to any manufacturer: GMP as recommended by WHO is a published standard, and the attestation of conformity with it is made by the certifying authority within the model CoPP — not by WHO, and not by us. Our role: supply attested copies to support a partner's filing, in the language and legalisation format the destination market requires.

Statement of marketing-authorisation status

A short authority statement that an authorisation exists for a named product, used by importing agents to screen bids in an international tender. WHO lists it as a document issued in connection with the Scheme but not part of it, and it is not a substitute for a CoPP.

Certificate of analysis

Issued by our own quality control laboratory for the batch it tested. A manufacturer's quality record, not a regulatory instrument: it certifies test results against a specification and nothing else.

What we supply towards a partner's CoPP application

• The name and address of each manufacturing site with its activity identified separately — manufacture of the finished product, manufacture of bulk, quality control, batch release, primary packaging and secondary packaging — since the model certificate lists sites by activity, not as a single address.
• The complete unit formulation: each active substance by International Nonproprietary Name with the amount per unit dose, and every excipient with its quantity. Release of quantitative composition to the certifying authority is subject to the agreement of the authorisation holder, so this is provided under the confidentiality terms already in place.
• The dosage form, strength, pack sizes and the description of the primary and secondary packaging as manufactured, matched to the artwork version in force.
• Draft product information for health professionals and for patients, prepared against the destination market's format so that the applicant can align it with the text the authority will approve.
• Our own manufacturing and quality records: the finished-product specification and its version, batch manufacturing record summaries, in-process control and release data, stability data supporting the shelf life claimed, and the site's qualification and validation status.
• Written confirmation, where the certifying authority asks for it, that identical GMP standards are applied to every batch made at the site including batches destined exclusively for export, and consent to the release of relevant inspection reports in confidence should a quality defect be investigated.
• What we do not supply, because it is not ours to supply: the marketing-authorisation number and date, the identity of the authorisation holder, and the answers to the authority's own questions about inspection periodicity and GMP conformity.

Timing, language and legalisation

WHO recommends that a certifying authority set a standard time frame and aim to issue a certificate within 30 working days once the applicant has submitted sufficient documentation, and to provide a duplicate — clearly marked as such — ideally within 20 working days. Those are targets for the authority, not commitments we can make on its behalf, and actual timing varies by market and by season. Certificates are prepared in the working language of the certifying authority, which may issue bilingually; providing any certified translation the importing authority requires is the applicant's responsibility. On authentication, the current WHO guidance discourages requesting authorities from imposing legalisation, notarisation, embassy attestation or apostille, on the grounds that these cause undue delay and that authenticity is better assured by verification with the certifying authority or by a secure electronic certificate. Many markets nonetheless still demand them, so we plan for that step where it applies and say so in the quotation rather than pretending it away.

Document tiers

Tier 1 — public

Available on this site with no request and no verification: the monograph pages, the specification overview for each product (which test parameters a dosage form carries and which standards they are set against, without numerical limits), the register of standards we design and qualify against, the descriptions in the document register above, and specimen documents. No batch data, no results, no certificates.

Tier 2 — partner, on request

Released to a verified licensed distributor, importer or its named regulatory agent: the batch certificate of analysis, the finished-product specification with its acceptance criteria, the technical package (stability summary, method summaries, artwork and labelling pack, packing and serialisation data), the safety data sheet, and consignment documentation. Batch documents follow licence verification; the technical package additionally requires a mutual confidentiality agreement.

Tier 3 — dossier level, restricted

Released only under an executed confidentiality agreement together with a supply or filing agreement naming the product and the destination market: Module 3 quality data, full analytical method validation and process validation reports, batch manufacturing record summaries, the applicant's part of an active substance master file with a letter of access, and method transfer packages. Issued to named recipients, paginated, watermarked with the recipient's name and a document reference tied to that recipient, and re-issued rather than forwarded.

Verification gate (Tiers 2 and 3)

Before any document leaves the site we verify the requesting party's wholesale distribution or import authorisation for prescription medicines in the destination market, against the issuing body's own register where one is published and by written confirmation where it is not. The verification is recorded with the document reference, so every issued document has a traceable recipient and a traceable basis for release. Requests without a verifiable licence are declined, and no document at any tier is released to patients or to the general public.

Not released at any tier

Executed batch records in full (reviewable on site during an audit), the restricted part of an active substance master file, third-party confidential data held under agreement, and anything that would identify an inspection, an auditor or an authority. We publish no certificate numbers, issue dates or issuing bodies.

Request flow and turnaround

1. 01

   01 · Enquiry received

   Company name and registered address, destination market, licence details, and precisely what is needed — product, pack format, batch numbers for batch documents, and the filing, tender or customs entry the request supports. Acknowledged within one working day.

2. 02

   02 · Licence verification

   We verify the wholesale distribution or import authorisation with the issuing body. Typically 2–3 working days where the register is published online; up to 10 working days where verification depends on written confirmation or a legalised copy. Nothing is released until this closes.

3. 03

   03 · Scope and agreement

   Tier 2 batch documents need no further agreement. A mutual confidentiality agreement for the technical package takes 3–10 working days depending on the partner's legal review; a Tier 3 release additionally requires an executed supply or filing agreement naming the product and market.

4. 04

   04 · Compilation and quality check

   Re-issue of a batch certificate of analysis, 1–2 working days. Finished-product specification or safety data sheet, 3–5 working days. Stability package or analytical method summaries, 10–15 working days. Module 3 quality documentation for a market we have not filed into before, 4–8 weeks. Every pack is checked against the current controlled version before release.

5. 05

   05 · Issue

   Released as a controlled PDF carrying a version and issue reference and the recipient watermark, to the named contact only. Certified or notarised hard copies add 5–10 working days plus courier transit. Consignment documents — packing list, shipping file, certificate of analysis and EPCIS data — travel with each despatch by default.

6. 06

   06 · Authority-dependent documents

   For a CoPP, free sale certificate or attested GMP documentation we prepare the application pack within 5–10 working days of receiving the partner's data. Issue then rests with the authority — WHO recommends certifying authorities aim for 30 working days, and 20 for a duplicate — and legalisation or apostille, where a market still demands it, adds a further 2–6 weeks.

7. 07

   07 · Re-issue and change notification

   Additional or certified copies of an already-issued document, 2 working days. Changes to a specification, artwork version or shelf life are notified to affected partners under the quality agreement rather than waiting to be requested, with the superseded version marked as such.