This is a ready-to-use certification register for the Qualified Person’s personal act under Article 51 of Directive 2001/83/EC and EU GMP Annex 16, Section 1.1. It is a narrower and more specific record than a general batch disposition log: its only job is to make the legal certification act, one named person, one batch, one contemporaneous entry, retrievable and reconstructable. Replace every <<FILL: ...>> placeholder with your own specifics and route the register through document control. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
Why this register is not the same as a batch disposition record
Many quality systems keep a batch disposition record that captures release, reject, or hold decisions for both EU and non-EU markets. That record is useful, but it is not, on its own, the register Annex 16, Section 1.1 requires: a place where the QP’s specific confirmation, that a specific batch was produced and tested as the law and the marketing authorisation require, is recorded in the QP’s own name and is attributable to the QP personally. Where a company’s disposition record already captures every field below with the QP as the named decision-maker and a date/time stamp, that record can serve as the register. Where it does not, for example because a delegated function signs disposition and only later routes to the QP, keep this register as the specific, unambiguous evidence of the Article 51 act.
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Batch / lot number | text | Yes | QA / QP | At certification |
| Product name / presentation | text | Yes | QA / QP | At certification |
| Marketing authorisation number(s) and market(s) | text | Yes | QA / QP | At certification |
| Manufacturing site(s) in the chain | text | Yes | QA / QP | At certification |
| Batch record / disposition package reference | ID | Yes | QA | At certification |
| Deviations / OOS linked, and status | text | Yes, or “none” | QA / QP | At certification |
| QP declaration reference (API GMP basis) | ID or “N/A” | Yes | QP | At certification |
| Reliance basis reference(s) (quality agreement, other-stage QP confirmation) | ID or “N/A” | Yes | QP | At certification |
| Decision | Certified / Held / Rejected | Yes | QP | At certification |
| If held or rejected, reason | text | Yes if applicable | QP | At certification |
| Certifying QP name | name | Yes | QP | At certification |
| Certification date and time | date/time | Yes | QP | At certification, contemporaneous |
| Signature (wet ink or qualified electronic) | signature | Yes | QP | At certification |
The register
| Batch | Product | MA no. / market | Site(s) | Package ref | Deviations/OOS | QP declaration ref | Reliance basis ref | Decision | Reason if held/rejected | QP | Date/time |
|---|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions
- Make one entry per batch, at the moment of certification, not before and not retrospectively after the batch was already used or distributed.
- The QP enters or reviews and signs every field before the batch is treated as certified; a register entry the QP did not personally attribute to themselves does not satisfy Article 51.
- Where certification is Held or Rejected, record the reason at the same time as the decision, not as a later addendum.
- Where an electronic system captures this data, the record must be attributable to the individual QP (unique login, no shared credentials), time-stamped, and the entry must not be editable after signature without a documented, audit-trailed correction.
- Cross-reference the disposition package, the QP declaration, and any reliance basis document by their own IDs rather than re-describing them in the register; the register indexes the evidence, it does not replace it.
Retention
Retain the register and its entries per the records retention schedule applicable to batch records for the market(s) certified, for not less than <<FILL: retention period, e.g. 1 year after expiry or 5 years after certification, whichever is longer, aligned to your MA commitments>>. Entries are never deleted or overwritten; a correction is a new, dated, attributed entry referencing the original.
Acceptance criteria
The register is sound when every certified batch has exactly one contemporaneous entry attributable to a named QP, every field is complete (or explicitly “N/A” with a one-line reason), every Held or Rejected entry carries a reason, no batch was released for sale before its certification entry exists, and an auditor can pick any batch number from distribution records and find the matching register entry within minutes.
Filled specimen
The following completes the register for the worked example in the linked article: an imported sterile injectable certified at an EU release site. Values are illustrative.
| Field | Entry |
|---|---|
| Batch | A-4471 |
| Product | Generic Injectable 10 mg/mL, 12,400 units |
| MA no. / market | MA-EU-00234-7, EU/EEA |
| Site(s) | API: <<FILL: third-country site>>; fill/finish: <<FILL: EU site>> |
| Package ref | BR-A4471, CoA-QC-A4471 |
| Deviations/OOS | DEV-2026-0188 (autoclave loading hold-time excursion), impact assessment concludes no effect on sterility assurance |
| QP declaration ref | QPD-2025-011, API site audited 2025-04-09 against ICH Q7 |
| Reliance basis ref | QAG-2024-018 (quality agreement with API supplier) |
| Decision | Certified |
| Reason if held/rejected | Not applicable |
| QP | Dr. R. Gomez |
| Date/time | 2026-07-20, 16:42 local |
A second entry for the same batch number should never appear. If the autoclave excursion impact assessment had instead been inconclusive, the correct entry is Decision: Held, with the reason stated as “sterility assurance margin for extended hold time not established; investigation DEV-2026-0188 escalated to full investigation,” dated at the moment that decision was made, not weeks later once the investigation closed.
Common inspection findings this log prevents
- A batch found on the market or in distribution records with no matching, attributable register entry.
- Register entries that show a decision but not the named QP, or that are signed by a delegate on the QP’s behalf.
- Certification entries made or edited after the batch had already left the site, backdated to appear contemporaneous.
- A single “batch release” record that conflates the QP’s certification with a separate function’s later administrative release, with no way to tell which act happened when.
- Held or Rejected entries with no reason recorded, so a later reviewer cannot tell why a batch never reached certification.
How to adapt this log
- If your quality system’s existing disposition record already captures every field above with the QP as the attributable decision-maker, use it and drop this as a parallel log; do not maintain two competing sources for the same legal act.
- Add columns for additional markets if the same certifying QP releases into more than one authorisation simultaneously.
- For electronic systems, confirm the audit trail configuration meets 21 CFR Part 11 / EU GMP Annex 11 expectations for attributable, time-stamped, non-editable-after-signature entries.
- Set your retention period against your actual MA commitments and batch record retention policy, and confirm it with regulatory affairs.