Batch disposition and QP release with every blocker named before the QP signs
Every batch reaches the QP with a cited dossier and every blocker named.
See one case, screen by screen ↓Software that takes a finished batch from its last QC result to a signed certification and the stock release. Batch Disposition & QP Release sets six release gates over the 18 checks of EU GMP Annex 16 §1.7, each from cited records, names every blocker with its owner, and keeps the Qualified Person's signature locked until all six gates are clear.
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Before a batch can leave quarantine, a Qualified Person — or, in the US, the quality unit — has to confirm it was made and tested as the marketing authorisation and GMP require. The evidence sits in seven systems: the batch record review in the MES, results and the CoA in LIMS, deviations, changes and complaints in the QMS, environmental monitoring, material and supplier status in ERP, the regulatory system and the serialisation hub. The QA release team chases each piece by e-mail and spreadsheet, and the QP reads it all again.
The blockers surface late and nobody owns them: a major deviation whose impact assessment QA has not approved, a lapsed supplier audit, a drug-substance QP confirmation that never arrived from the other site. A change approved in the EU but still pending in Canada has to narrow the certificate, or a batch ships where it is not licensed. Meanwhile the stock sits: €63.6 M was in quarantine at the sample site on the day of the demo.
Estimated split of the 2.6 days a batch spent on evidence assembly and review at the sample site, by hand and with the solution.
A release coordinator and six specialist agents set the six release gates of every batch, each from cited records; the Qualified Person certifies when all six are clear.
Batch VL26-0418 — 48,210 prefilled syringes of Veltrimab 150 mg/mL for Germany, France, the Netherlands, Spain and Italy, needed at the EU distribution centre on Oct 9. Its QC results were released at 07:52. Here is what happens next at Plant 3 — Leiden, screen by screen, in the working solution.
Lena opens the release gate. Above it, the 8 batches in quarantine, each with six gate pips. Below, VL26-0418's six gates — batch record, deviations, QC results & CoA, environmental monitoring, changes & markets, stability — all not checked yet, and a seventh tile, QP certification, that opens only when all six are clear. The source viewer already shows the batch record review report: 214 of 214 steps signed.
“The signature stays locked until every gate is clear. Agents never certify — the decision and the e-signature stay with you, Lena Ortiz.”
The runway lays each batch from the day it was made to its need date: 8 in quarantine worth €63.6 M, 1 forecast to miss. CR26-1102, Corventa 20 mg for DE · PL · CZ, is needed Oct 9 but forecast Oct 11 — its dissolution OOS is in a Phase II investigation. VL26-0418 is still at gates to check, with two days left.
“CR26-1102 will miss its Oct 9 need date at the current forecast — Priya Raman informed.”
The batch record reader confirms 214 of 214 steps signed, 3 exceptions dispositioned and 11 materials released with audits current. The deviation and change tracer finds 2 deviations, one open. The results and CoA checker has 17 of 17 results in the registered specification and sterility no growth. The environment checker reads 1,284 samples from the fill day; the market and serialisation checker confirms 48,210 identifiers uploaded.
On screen: “typically under a minute · by hand 2–4 hours”.
Four gates clear, one blocked, one to review. DEV-26-1187 is a major deviation: after a stopper-bowl jam the formulated bulk was held 26 h 40 min against the 24 h batch-record limit. Hold-time study VR-114 supports 36 h at 2–8 °C and the impact assessment concludes negligible impact, but QA approval is pending — Omar Haddad, due 12:00. Changes & markets is clear for the EU only: the second-source stopper is approved in the EU and still pending in Canada.
The deviation and change tracer never marks a deviation closed — it cites the approval record, not the summary.
One click on “Ask Omar to approve” sends him the deviation with its cited records. He approves the impact assessment — negligible impact, batch added to the ongoing stability programme — and closes the deviation. The release coordinator re-checks only the deviations gate, which turns clear: 3 of 3 checks met, each with its record.
“Omar Haddad approved the impact assessment — the deviations gate is clear.”
Environmental monitoring is to review. On Sep 18, the fill day, settle plate B-07 in room F-214 read 6 CFU / 4 h against the Grade B action limit of 5; the organism was Micrococcus luteus. Every Grade A sample read 0 CFU, and EM-26-0311 was closed on Oct 3 with no impact on the batch. The monitoring summary opens beside it with the cited passage highlighted.
An open action-level investigation is always a blocker; a closed one comes to the QP as an item to read.
Lena reads the investigation and clicks “Accept — no impact on the batch”. The item is marked accepted by Lena Ortiz, the gate turns clear, and the seventh tile changes to unlocked: every gate clear, sign now.
“EM-26-0311 accepted — Environmental monitoring is clear · certification unlocked.”
The certification statement cites Directive 2001/83/EC Art. 51 and Annex 16, with all six gates ticked. Markets: DE · FR · NL · ES · IT, with Canada excluded under CC-26-0233. Cleared today: DEV-26-1187 approved by Omar Haddad, EM-26-0311 accepted by her. She signs with the meaning “Certified for release (Annex 16)” and her password.
The drafted certificate becomes QPC-2026-1043, electronically signed by Lena Ortiz with the meaning and the time, listing the markets covered and the item she accepted. The release steps run on their own: the register entry is written, the signed PDF issued, ERP stock moves from Quarantine to Unrestricted for the five markets, and the warehouse and Priya Raman are told.
The certificate drafter drafts only — the QP signs.
QPC-2026-1043 sits at the top of the certification register beside every certification, US approval and rejection — batch, markets, decision, signer, time and ERP stock status. The register is immutable, holds its e-signed entries for at least five years and is open to inspectors: 341 entries this year.
The same batch, seen by the five people who carry it — what their week looked like, and what it looks like now.
A release coordinator and six specialist agents set the six release gates of every batch, each from cited records; the Qualified Person certifies when all six are clear.
Opens the six release gates when the batch record review is complete or the last QC result is released — 18 checks over Annex 16 — sends each check to the right specialist, collects the evidence and sets each gate: clear, to review, or blocked with an owner and a due date. Re-checks only the affected lines when a source record changes.
Reads the electronic batch record review: steps signed, exceptions and how each was dispositioned, in-process controls, inspection rejects and yield, against the master batch record limits.
Compares every release result with the registered specification for the destination market, checks sterility and endotoxin, the age of ongoing stability data and the OOS / OOT register.
Finds every deviation, investigation, complaint and change that touches the batch, its materials or its equipment, and tests each against Annex 16 section 3 and the market approvals.
Pulls viable and non-viable monitoring for the batch's rooms and sessions, personnel monitoring, water and clean utilities, and every excursion with its organism, investigation and status.
Checks material release and supplier approval in ERP, audit currency for every party in the supply chain, technical agreements and QP confirmations from other sites.
Checks each destination market against the marketing authorisation and the status of every change, the qualified cold-chain lane and the serial-number upload; drops a market whose approval is missing and says why.
Drafts the certificate and the register entry from the six gates, listing the markets covered and the items the QP accepted, and leaves the signature block for the QP.
Certifies, holds or rejects. The agents propose; a named person decides.
Ask in plain words — every answer cites the record behind it.
What is blocking VL26-0418?
Two gates are not clear. Deviations is blocked: DEV-26-1187 is not closed — the formulated bulk was held 26 h 40 min against the 24 h limit; the hold-time study supports 36 h and the impact assessment says negligible, but QA approval is pending, Omar Haddad, due 12:00. Environmental monitoring is to review: a Grade B settle plate at 6 CFU on the Sep 18 fill, closed with no impact. The batch is needed on Oct 9; if Omar approves today you can certify this afternoon.
Why is Canada excluded?
VL26-0418 is the first batch with stoppers from the second-source supplier, lot WE-7731. The EU type IB variation was approved on Sep 2, but Canada is still pending. Under Annex 16 §1.7.5 and 1.7.15 you can certify it only for markets whose licence covers the change — the certificate lists DE, FR, NL, ES and IT.
Which batch is at risk of missing its supply date?
CR26-1102 (Corventa 20 mg, DE · PL · CZ). It is needed on Oct 9, but the forecast release is Oct 11 because the dissolution OOS is in Phase II — Phase I found no lab error. Priya Raman has the alert. Every other batch is forecast before its need date.
Let minor deviations close after certification when the impact assessment is approved
Done — new release rule: a minor deviation may stay open at certification when its impact assessment is approved and the registered specification is met (Annex 16, section 3). Major and critical deviations still block. The rule is live in Settings as version 7 and recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
What counts as a blocker or a note, who signs for each market and where the evidence comes from are settings. The rules are versioned, and every change is on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Any open deviation | Blocks certification | Always on — required by Annex 16; a rule below can allow an exception |
| An open action-level EM investigation | Blocks certification; closed excursions show as a note for the QP | On · Off |
| A change not approved for a market | Restricts the certificate to approved markets | On · Off |
| Supplier status “conditional” | Shows as a note; lapsed audits of critical materials stay blockers | On · Off |
| Ongoing stability data no older than | 120 days | 30 to 365 days, in steps of 30 |
| Supplier audits valid for | 36 months | 12 to 60 months, in steps of 6 |
| EU certification | Lena Ortiz | Lena Ortiz · Dr. Maya Chen |
| Second signature on a rejection | Dr. Maya Chen, Head of Quality | Dr. Maya Chen · Omar Haddad |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample batch data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (published review-by-exception programmes — 1–3 days off release lead time; SAP, “Turbocharging batch release processes” — a team of quality-control professionals takes around 40 hours to reach a release decision). Regulatory context: EU GMP Annex 16, Directive 2001/83/EC Art. 51, 21 CFR 211.22. People, companies, products, batches and records named on this page are fictional — characters and sample data in the working solution.
Software that takes a finished batch from its last QC result to a signed certification and the stock release. Batch Disposition & QP Release sets six release gates over the 18 checks of EU GMP Annex 16 §1.7, each from cited records, names every blocker with its owner, and keeps the Qualified Person's signature locked until all six gates are clear.
Each gate is set by a specialist agent from the source records. A gate is blocked when the evidence shows a requirement is not yet met — an open deviation, an open OOS, a lapsed audit of a critical material — and the blocker names the person who can clear it and the due date. It is to review when the requirement is met but the QP should read why, such as a closed EM excursion, and it clears when the QP accepts it.
The market and serialisation checker compares each destination market with the regulatory status of every change the batch uses. A change not approved for a market restricts the certificate to the approved markets — in the demo, the second-source stopper was approved in the EU and pending in Canada, so the certificate covers DE, FR, NL, ES and IT only.
Yes. In the US the quality unit approves or rejects each lot under 21 CFR 211.22. The release gate uses the same six gates and 18 checks, swaps the market lines for the BLA and US serialisation, and routes the signature to the quality unit with the meaning “Approved for distribution”.
When an owner closes or updates a record, the release coordinator re-runs only the checks that record touches. In the demo, Omar Haddad's approval of the deviation re-checked the deviations gate, which turned clear without re-reading the rest of the batch.
Yes. The agents never certify, hold or reject a batch. Only the Qualified Person — or the US quality unit — disposes, with an electronic signature that records its meaning, name and time; accepted items carry the QP's name; and a rejection needs the Head of Quality's second signature.
Yes. What blocks and what shows as a note, the maximum age of stability data, how long supplier audits stay valid, who signs for the EU, the UK and the US, and who co-signs a rejection are all settings. A QP can also describe a new rule in a sentence; it is added to Settings as a new rules version and recorded on the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your release SOPs, specifications and a sample of past batch records — and it goes live once every quality gate has passed. We will walk you through it on your own batches first.
Any batch-record question answered in seconds, cited to the page and step.
1-min demoValidation Document AutomationProtocols drafted in minutes, every value traced to its source.
1-min demoManufacturing Batch AnalyticsBatch analysis that took three months now takes hours, with the query behind every answer.
1-min demoWe'll run Batch Disposition & QP Release on a sample of your own past batch records.