Post-approval Change Classifier

1. What this module does

For each change you give a short description, a type code, its impact, and whether it is covered by an approved protocol (PACMP) or is an established condition. The tool suggests the US category (annual report, CBE-0, CBE-30 or prior approval supplement under 21 CFR 314.70 or 601.12) and the EU variation type (IA, IA_IN, IB or II, with the classification code from the Variations Guidelines).

It lists the CTD sections to update and the supporting data each change needs, and writes the summary of changes for the cover letter.

What you get

• A Word or PDF report: Post-approval change classification, with the cover letter text.

2. Before you start

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

• The approved application type (NDA or ANDA, or BLA) and product class.
• Each planned change with its type, impact (minor, moderate, major), PACMP status, established condition status and, for batch size changes, the factor.
• A note of the data you have: comparability, comparative dissolution, stability.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/lifecycle-changes.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 product and application

   Enter the product, choose the region, the US application type and the product class (non-sterile solid, liquid or semi-solid, sterile, biological).

   

2. List the changes

   One row per change. The Type is a code such as site_dp, batch, process, spec_tighten or method; the panel note lists them all. Say whether a PACMP covers the change and whether it is an established condition.

3. Read the classification

   The headline gives the highest filing: "6 changes · highest: CBE-30 supplement. No change needs prior approval." The table shows each change with its US category, EU type, the sections to update and the data needed.

   

4. Resolve alerts and download

   Alerts flag missing batch size factors, changes marked as not an established condition despite a major impact, and missing comparability, dissolution or stability data. Then preview and download the report.

   

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 · Product and application

2 · Planned changes

Type is one of: site_dp, site_ds, site_test, site_pack, batch, process, equipment, formulation, spec_tighten, spec_add, spec_widen, spec_delete, method, method_less, shelf_ext, shelf_red, ccs, supplier_exc, supplier_sm. A plain description also works.

5. Checks and alerts

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

• Each change is read into a type; anything uncertain is noted ("read as").
• Batch size factor given for batch size changes.
• A change marked as not an established condition but with a moderate or major impact is flagged; established conditions not defined are noted.
• Comparability data, comparative dissolution and stability data mentioned where the change needs them.
• Changes that need prior approval are flagged; several changes can be grouped (EU worksharing or grouping, US combined supplements).

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 changes (cover letter text). 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 applies 21 CFR 314.70 (NDA and ANDA) or 601.12 (BLA) and FDA guidance on changes to an approved application. EU mode applies the Variations Regulation and the classification guidelines (2013/C 223/01), giving the type and the condition code. ICH Q12 established conditions and PACMPs can lower the category in both. These are suggestions: confirm the category with your regulatory team or the agency when in doubt.

8. Working with other modules

• Write the updated sections with the module that covers them, for example the Process & Controls Writer for a new site or the Specification Builder for a tightened limit.
• Stability support for the change comes from the Stability Studio.

9. Common pitfalls

• Describing a change too vaguely for the type to be read.
• Marking everything as minor impact: the category depends on the impact you state.
• Forgetting that a PACMP must be approved before it lowers the category.
• Not listing the data you have, so every data alert stays open.

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. Widen a specification instead of tightening it

   In the changes table, change the type of the dissolution change from spec_tighten to spec_widen.

   Expected resultThe headline says the highest filing is now a prior approval supplement.

2. Classify for the EU

   Set Submission region to EU.

   Expected resultThe facts now show the EU variation types for the changes.