Batch Record Review & Release

1. What this module does

You enter the results with their specifications, the review checklist and the deviations. The tool checks each result and each checklist item and decides whether the batch is ready for release.

For the EU it adds the QP checks: compliance with the marketing authorisation, import testing for batches made outside the EU and deviations assessed under Annex 16 section 3.

What you get

• A Word or PDF report: Batch record review and release (or QP certification).

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The certificate of analysis results and specifications.
• The completed batch record review checklist.
• Deviations, OOS results and changes affecting the batch.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/batch-release.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the batch

   Enter the product, batch, manufacturing and expiry dates, and the market.

   

2. Enter results, checklist and deviations

   One row per test, per checklist item (OK, NOK or NA) and per deviation.

3. Read the result

   The headline gives the decision: "Batch B2611: ready for release (US) and QP certification (EU)".

   

4. Resolve alerts and download

   A result out of specification, a NOK item or an open critical or major deviation is critical. Then preview and download the release record for signature.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Batch

2 · Certificate of analysis

3 · Review

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• Each result against the specification.
• Review checklist complete.
• Deviations closed or assessed; EU import testing and MA compliance.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Release statement. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US: the quality unit releases under 21 CFR 211.22 and 211.192. EU: a QP certifies under Directive 2001/83/EC Article 51 and EU GMP Annex 16.

8. Working with other modules

• Out-of-specification results are investigated in Investigation Studio (OOS, deviation, CAPA); release data feed the Annual Product Review.

9. Common pitfalls

• Releasing with a deviation still open and not assessed.
• Forgetting EU import testing for a batch made outside the EU.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Put a result out of specification

   Change the assay result from 99.7 to 94.6.

   Expected resultThe headline shows the batch is not ready for release.