This is a ready-to-use form for the QP declaration (written confirmation of GMP compliance of an active substance manufacturer), a dossier-level deliverable distinct from per-batch certification. It confirms, at the level of a site and an active substance, the basis on which the QP is satisfied the active substance is manufactured to GMP, so the finished-product manufacturer’s QP can rely on it, audit after audit, batch after batch. Replace every <<FILL: ...>> placeholder and route through document control. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
What this form is and is not
The QP declaration is required to support a marketing authorisation application or variation under Directive 2001/83/EC as amended by Directive 2011/62/EU (the Falsified Medicines Directive). It states, for a named active substance manufactured at a named site, that the QP of the finished-product manufacturer has verified GMP compliance, typically through audit. It is not the per-batch certification (see the linked certification register) and it does not itself release any batch; it establishes the standing basis that per-batch certification later relies on.
An alternative basis to a company-performed audit exists where the active substance is imported from a third country currently on the European Commission’s published list of countries whose regulatory framework has been assessed as providing GMP assurance equivalent to the EU’s; in that case the declaration cites the equivalence basis instead of, or alongside, an audit. Confirm current list membership before relying on it, since it is reviewed and can change.
Form fields
Header
| Field | Entry |
|---|---|
| Declaration reference number | <<FILL>> |
| Version | <<FILL>> |
| Date issued | <<FILL>> |
| Linked marketing authorisation(s) | <<FILL: MA number(s) / market(s)>> |
| Finished-product manufacturing site | <<FILL: name and address>> |
| Responsible QP (name, site) | <<FILL>> |
1. Active substance and site(s) covered
| Active substance | Manufacturing site (name, address) | Manufacturing step(s) covered at this site |
|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: e.g. full synthesis, final intermediate onward, micronisation only>> |
2. Basis of confirmation
| Field | Entry |
|---|---|
| Basis | <<FILL: company audit / third-party audit on the company's behalf / equivalence-list country / other, state basis>> |
| Audit date (if applicable) | <<FILL>> |
| Auditor(s) and affiliation | <<FILL>> |
| Audit report reference | <<FILL>> |
| Audit outcome summary | <<FILL: e.g. no critical findings; N majors, all closed with verified CAPA>> |
| If equivalence-list basis: country and current list status confirmed on (date) | <<FILL, or N/A>> |
| Site’s manufacturing/GMP authorisation or certificate reference (e.g. EudraGMDP entry) | <<FILL>> |
3. Statement of compliance
<<FILL: standard statement, e.g. "The undersigned Qualified Person of [finished-product manufacturer] confirms that the active substance [name] manufactured at [site, address] is manufactured in accordance with the detailed guidelines on good manufacturing practice for active substances referred to in Part II of the EU GMP Guide (equivalent to ICH Q7), on the basis described in Section 2 above.">>
4. Currency and re-confirmation
| Field | Entry |
|---|---|
| Audit interval commitment (risk-based) | <<FILL: e.g. every 3 years, or shorter for higher-risk sites>> |
| Next audit due | <<FILL: date>> |
| Trigger events requiring earlier re-confirmation | <<FILL: e.g. site GMP certificate lapse, statement of non-compliance, critical finding at the site, significant process change>> |
| Declaration valid until (or “until next audit / trigger event”) | <<FILL>> |
5. Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Qualified Person | <<FILL>> | ||
| Quality Assurance (review) | <<FILL>> |
Acceptance criteria
A QP declaration is acceptable when it names every active substance site actually used and listed in the MA dossier (no site missing), the basis of confirmation is real and current (an audit the QP has personally reviewed the report of, or a currently valid equivalence-list basis), the audit interval and next-due date are set on a documented risk basis rather than left open-ended, and the declaration is re-confirmed on any trigger event rather than only on the fixed schedule.
Filled specimen
The following completes the form for the API site referenced in the linked article’s worked example. Values are illustrative.
| Field | Entry |
|---|---|
| Declaration reference | QPD-2025-011 |
| Linked MA | MA-EU-00234-7 |
| Finished-product site | <<FILL: EU fill/finish site>> |
| Responsible QP | Dr. R. Gomez |
| Active substance / site | Compound XYZ API, <<FILL: third-country manufacturer, address>>, full synthesis through final intermediate and API isolation |
| Basis | Company audit |
| Audit date | 2025-04-09 |
| Auditor | Corporate Supplier Quality audit team (2 auditors), report reviewed in full by the QP |
| Audit report reference | AUD-2025-0037 |
| Audit outcome | No critical findings; 2 major findings (cleaning validation documentation gap, deviation trending not formalized), both closed with verified CAPA by 2025-08 |
| Site authorisation reference | EudraGMDP entry checked 2026-06-15, manufacturing authorisation current |
| Audit interval | Every 2 years (API is a single-source, high-criticality input) |
| Next audit due | 2027-04 |
| Declaration valid until | Next audit, or earlier on trigger event |
The API site’s own manufacturing authorisation was checked against EudraGMDP separately from the audit, on a different date, which is expected: the audit establishes practice on the ground, the database check confirms the authority’s own record still agrees. Both are on file and both are dated, so either can be reconstructed independently.
Common inspection findings this form prevents
- A QP declaration on file that omits an active substance site actually used, discovered only when the batch record names a site the declaration never covered.
- A declaration that cites an audit, but the audit report itself cannot be produced or was never reviewed by the QP who signed the declaration.
- A declaration with no re-confirmation trigger, so a critical finding or a lapsed authorisation at the API site goes unnoticed until the next scheduled audit, sometimes years later.
- An equivalence-list basis claimed for a country that has since been removed from, or was never actually on, the current list.
- Audit intervals set generically for every supplier regardless of criticality, rather than risk-based.
How to adapt this form
- Set your declaration numbering and link it explicitly to the MA(s) and variation(s) it supports.
- List every active substance site actually in current use, cross-checked against the dossier and the batch record system, not from memory.
- Set your own risk-based audit interval policy and cite it as the basis for the next-due date.
- If relying on the equivalence-list basis for a third country, confirm current list status at the time of each declaration and keep that confirmation on file.
- Confirm the current EU GMP Guide Part II / ICH Q7 reference and the current Directive 2011/62/EU citation before issue.