Reference Standard Qualification

1. What this module does

You enter the test results with their criteria. For a primary standard the tool assigns the content by mass balance (100 minus organic impurities, corrected for water, solvents and residue on ignition) and compares it with qNMR. For a secondary standard it assigns the mean assay against the primary standard.

It checks identity by at least two orthogonal techniques, every result against its criterion, the storage and the requalification date.

What you get

• A Word or PDF report: Reference standard qualification report.

2. Before you start

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

• The candidate lot and, for a secondary standard, the primary standard.
• Identity, purity, water, solvents, residue on ignition and qNMR or assay results.
• Storage conditions and requalification interval.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/reference-standard.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 standard

   Choose primary or secondary, and enter the lot and, for a secondary standard, the primary standard it is traced to.

   

2. Enter the results

   One row per test with the result and criterion. A criterion can be a range, a limit or a statement. For a secondary standard, enter the assay results against the primary standard.

3. Read the result

   The headline gives the lot and the assigned content: "RS-CMX-101-002 qualified · assigned 99.6%". The note gives the mass balance and qNMR values and the requalification date.

   

4. Resolve alerts and download

   A failing result is critical. Too few identity tests, missing mass balance inputs, a qNMR difference above the limit and missing storage or requalification 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 · Standard

2 · Tests

One row per test. The criterion can be a range (99.0–101.0), a limit (≤ 0.5, NLT 99.5) or a statement (concordant with the structure).

3 · Storage and requalification

5. Checks and alerts

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

• Each result against its criterion.
• Two or more identity tests.
• Primary: organic impurities, water, solvents and residue for the mass balance; qNMR agreement. Secondary: traceability, number of preparations, %RSD and assay range.
• Storage and requalification date.

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: Discussion and conclusion. 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 follows USP <11> and section VII of the FDA analytical procedures guidance. EU follows Ph. Eur. 5.12. Both follow ICH Q7 11.17–11.19.

8. Working with other modules

• The standard is listed in 3.2.S.5 and 3.2.P.6; assemble them in the QOS Composer & Dossier Assembler.

9. Common pitfalls

• Assigning 100% to a primary standard without a mass balance.
• Using a secondary standard that is not traceable to a primary.

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. Enter a high water result

   Change the water result from 0.21 to 0.8.

   Expected resultThe headline shows one test outside criteria.

2. Qualify a working standard

   Set the type to secondary and enter the assays 99.2;99.4;99.1;99.6;99.3;99.5.

   Expected resultThe headline shows the lot qualified with an assigned content of 99.4%.