Annual Product Review

1. What this module does

You enter the batches of the period, the critical attribute results in batch order, the quality events (OOS, deviations, CAPAs, complaints, returns, recalls, changes and variations) and the review items. The tool calculates Ppk per attribute and applies trend rules: 7 or more results on one side of the mean, or 6 rising or falling in a row.

It checks that rejected batches and OOS results have investigations, that every required review item is covered for the region, and writes the review with the summary, tables, conclusion and actions.

What you get

• A Word or PDF report: Annual product review, Product quality review, or both combined.
• A summary file with the period, batch counts and trends.

2. Before you start

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

• The review period (no more than about 12 months) and the marketing authorisations.
• Every batch made in the period with its status and yield, including rejected and pending ones.
• Critical in-process and release results in batch order.
• The quality events with their references, status and outcome, and text for each review item: materials, stability, qualification status, technical agreements, previous actions and post-marketing commitments.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/annual-product-review.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. Set the scope

   Enter the product, choose US APR, EU PQR or combined, and give the report number, period and marketing authorisations.

   

2. Enter batches, results and events

   One row per batch; one row per attribute and batch for results; one row per quality event. Tables can be loaded from Excel, CSV, Word, PDF or scans.

3. Read the trends

   The headline gives batches, rejections and adverse trends: "12 batches · 1 rejected · 1 adverse trend". The table shows Ppk and any trend for each attribute; in the example, dissolution is falling batch after batch while still within specification.

   

4. Resolve alerts and download

   Rejected batches without investigations, OOS results without records, adverse trends, low Ppk, open CAPAs and missing review items are flagged. Then preview and download.

   

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 · Review scope

2 · Batches

3 · Critical attribute results

One row per batch and attribute, in batch order.

4 · Quality events

Type: OOS, OOT, deviation, CAPA, complaint, return, recall, change, variation, reprocessing.

5 · Review items

5. Checks and alerts

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

• Period set and not longer than about 12 months.
• Rejected batches linked to an investigation; yields below the alert limit; reprocessed batches.
• Results outside specification without an OOS record; Ppk below 1.0 (major) or 1.33 (minor); trend rules (7 on one side of the mean, 6 rising or falling).
• Events without root cause or outcome; open CAPAs and investigations; recalls; complaints and returns stated (US).
• EU PQR items: starting and packaging materials, qualification status, technical agreements and post-marketing commitments; both: stability, variations and previous actions.

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: Summary of the review; Conclusion and actions. 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 mode follows 21 CFR 211.180(e): a review of a representative number of batches, complaints, recalls, returned or salvaged products and investigations. EU mode follows EU GMP Part I 1.10 and its twelve review items, including starting materials from new sources, qualification status of equipment and utilities, and technical agreements. Combined mode covers both.

8. Working with other modules

• Trends that need action are investigated in the Investigation Studio (OOS, deviation, CAPA) and changes go through Change Control.
• The PPQ data from the Process Validation Report are the baseline for the first review.
• Stability results come from the Stability Studio or Biologics Stability Studio module.

9. Common pitfalls

• Leaving rejected batches out of the batch list.
• Entering results out of batch order, which hides trends.
• Writing "no trends" without looking at results that are in specification but drifting.

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. Release the rejected batch

   In the batches table, change B26005 from rejected to released.

   Expected resultThe headline shows 0 rejected.

2. Leave out the previous actions

   Clear Actions from the previous review.

   Expected resultAn alert says the previous review actions were not reviewed.