This is a ready-to-use assessment for the specific judgement Annex 16, Section 1.5 and 1.6 require of a Qualified Person: that reliance on a party the QP did not personally observe is justified, on personal knowledge, on GMP and audit status, and on a written agreement, and that the QP retains overall responsibility regardless. It is not the quality or technical agreement itself (see the linked template) and not the QP declaration (a narrower, active-substance-specific dossier deliverable); it is the QP’s own documented conclusion that reliance on a named non-EU site is sound, with the evidence that conclusion rests on. 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.
Document control header
| Field | Entry |
|---|---|
| Document title | QP Reliance Basis Assessment |
| Document number | <<FILL>> |
| Version | <<FILL>> |
| Assessment date | <<FILL>> |
| Site being relied upon | <<FILL: name, address, country>> |
| Activity relied upon | <<FILL: e.g. API synthesis, sterile fill/finish, release testing>> |
| Certifying QP (assessment owner) | <<FILL>> |
| Linked quality/technical agreement | <<FILL: agreement number>> |
| Linked QP declaration (if API site) | <<FILL: reference, or N/A>> |
1. Purpose
This assessment documents the basis on which the certifying QP relies on a site that is not directly controlled or personally observed, so the reliance is demonstrable to an inspector and defensible if the relied-upon party’s work is later found deficient. It applies the Annex 16 principle that reliance distributes work, never accountability: a favorable conclusion here means the QP has assured themselves the arrangement is sound, not that responsibility has moved to the other party.
2. Scope
This assessment covers the named site and activity in the header. Complete a separate assessment (or a separate row set within one register) for each site the certifying QP relies on for a given product, since the basis for reliance, the audit history, and the GMP standard applicable can differ site by site.
3. Methodology
Score each element below as Established (documented, current, and sufficient on its own), Partial (some basis exists but has a gap), or Not established (no documented basis). Any “Not established” element blocks a favorable reliance conclusion until closed; a “Partial” element requires a stated compensating control or a closure plan with a date.
4. Personal knowledge basis
| Element | Evidence | Rating (Established/Partial/Not established) |
|---|---|---|
| The QP, or the pharmaceutical quality system on the QP’s behalf, has direct or documented indirect knowledge of the site’s operating standard (site visit, audit report review, ongoing performance data) | <<FILL>> | <<FILL>> |
| The QP has reviewed, personally, the most recent audit report or equivalent evidence, not only a summary or a pass/fail conclusion | <<FILL>> | <<FILL>> |
| Performance data since the last audit (deviations, OOS/OOT, complaint trend from this site) has been reviewed and is consistent with a state of control | <<FILL>> | <<FILL>> |
5. GMP and audit status
| Element | Evidence | Rating |
|---|---|---|
| The site operates under a GMP standard the company has assessed as at least equivalent to EU GMP (for non-EU sites: GMP-equivalence assessment, or coverage under a Mutual Recognition Agreement of applicable scope) | <<FILL>> | <<FILL>> |
The site’s manufacturing/import authorisation and GMP certificate, where such a register exists for the jurisdiction, are current and were checked within <<FILL: e.g. 12 months>> (for EU/EEA-recognized authorities, checked against EudraGMDP or the equivalent national register) | <<FILL>> | <<FILL>> |
| No open statement of non-compliance, warning letter, or import alert affecting the relied-upon activity | <<FILL>> | <<FILL>> |
| The audit interval applied to this site is risk-based and documented, and the next audit is scheduled within that interval | <<FILL>> | <<FILL>> |
| Any critical or major finding from the last audit has a verified, closed CAPA | <<FILL>> | <<FILL>> |
6. Written responsibilities
| Element | Evidence | Rating |
|---|---|---|
| A current quality or technical agreement defines the split of responsibilities for this activity, including who investigates deviations, who tests, and who notifies whom | <<FILL>> | <<FILL>> |
| The agreement’s change-control and deviation-notification clauses are specific (named contacts, defined timeframes), not open-ended | <<FILL>> | <<FILL>> |
| The agreement is signed by both quality units and is within its review/expiry date | <<FILL>> | <<FILL>> |
7. Reliance conclusion
| Field | Entry |
|---|---|
| Any “Not established” ratings above | <<FILL: none, or list>> |
| Compensating controls for any “Partial” ratings | <<FILL>> |
| Overall conclusion | <<FILL: Reliance justified / Reliance justified with the stated compensating controls / Reliance not justified, do not certify batches depending on this site>> |
| Residual risk accepted, and why | <<FILL>> |
| Monitoring commitment (what will be checked, how often, by whom, until the next full assessment) | <<FILL>> |
| Next scheduled reassessment | <<FILL: date, and any trigger event that brings it forward>> |
8. Roles
| Role | Responsibility |
|---|---|
| Certifying QP (assessment owner) | Reviews the evidence, forms and signs the reliance conclusion, remains accountable regardless of the conclusion |
| Supplier quality / audit function | Performs and reports the audit, maintains the audit schedule, flags trigger events |
| Quality Assurance | Maintains the quality/technical agreement, tracks its review date and notification performance |
| Regulatory affairs | Confirms GMP-equivalence or MRA scope actually covers the activity relied upon |
9. References
Directive 2001/83/EC, Article 51. EudraLex Volume 4, EU GMP Annex 16, Sections 1.5 and 1.6 (reliance and overall responsibility). EudraLex Volume 4, Chapter 7 (Outsourced Activities). ICH Q9, Quality Risk Management (basis for the risk-based audit interval).
Confirm the current version and clause numbers of each reference before issue.
10. Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Certifying QP | <<FILL>> | ||
| Quality Assurance | <<FILL>> |
Filled specimen
Illustrative, for the non-EU active substance site in the linked article’s worked example.
| Field | Entry |
|---|---|
| Site | <<FILL: third-country manufacturer>>, full synthesis through API isolation |
| Certifying QP | Dr. R. Gomez |
| Linked agreement | QAG-2024-018 |
| Linked QP declaration | QPD-2025-011 |
Personal knowledge basis: Established. QP personally reviewed audit report AUD-2025-0037 in full, not a summary; six months of deviation and OOS data since the audit reviewed by supplier quality and summarized to the QP quarterly, consistent with a state of control.
GMP and audit status: Established. Company GMP-equivalence assessment on file for the site’s regulatory framework; EudraGMDP is not applicable to this non-EU authority, so the national authorisation register was checked directly, current as of 2026-06-15; no statement of non-compliance or import alert found; audit interval set at 2 years given single-source, high-criticality status, next audit due 2027-04; two major findings from the 2025 audit both closed with verified CAPA by 2025-08.
Written responsibilities: Established. Quality agreement QAG-2024-018 defines deviation notification within 1 business day for critical events, names quality contacts both sides, requires 90 days’ prior notice for changes to registered details; agreement signed by both quality units, review date 2027-01.
Reliance conclusion: Reliance justified. No “Not established” ratings. Residual risk accepted: single-source API supply with a 2-year audit cycle carries ordinary single-source continuity risk, mitigated by the notification and change-control terms in the agreement, not by this assessment. Monitoring commitment: quarterly performance summary reviewed by the QP; any critical deviation, OOS, or statement of non-compliance triggers immediate reassessment ahead of schedule. Next scheduled reassessment: with the 2027-04 audit, or sooner on trigger.
Common inspection findings this assessment prevents
- Reliance asserted in an interview or in the QP declaration with no standalone document showing the QP’s own reasoning and evidence review.
- An audit report on file that the certifying QP never actually read, discovered when the QP cannot answer a specific question about the site’s findings.
- A quality agreement that exists but was never checked against the site’s current authorisation or GMP certificate status before reliance began.
- A “reliance justified” conclusion with no monitoring commitment, so a site’s condition can deteriorate for years between scheduled audits with nothing to catch it.
- No documented trigger for early reassessment, so a statement of non-compliance or a critical finding sits unaddressed until the next scheduled cycle.
How to adapt this assessment
- Complete one assessment per relied-upon site and activity; do not combine multiple sites into a single generic conclusion.
- For EU/EEA sites, cite the EudraGMDP check directly; for non-EU sites, cite whichever national or MRA-recognized register applies, or state that none exists and rely on the audit and equivalence assessment alone.
- Set your own risk-based audit interval policy and reference it rather than inventing a number for this assessment alone.
- Route the monitoring commitment into your actual supplier quality and audit-tracking system so it is executed, not just written down.
- Confirm every regulation and clause number in Section 9 against the current published version before issue.