Preservative Efficacy Test Report

1. What this module does

You enter the inoculum and the counts at each time point for each organism. The tool calculates the log reductions and checks them against the criteria for the product category in each region you choose.

It also checks the organisms tested, the inoculum level, that the test was done at the lowest preservative level in the specification, and method suitability.

What you get

• A Word or PDF report: Preservative efficacy test report (3.2.P.2.5).

2. Before you start

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

• The product category, preservative system and level tested.
• Inoculum and counts for each organism at each time point.
• Method suitability and in-use or end-of-shelf-life results.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/preservative-efficacy.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 test

   Choose the regions and product category, and enter the preservative level tested and the specification lower limit.

   

2. Enter the counts

   One row per organism with the inoculum and the counts at 6 h, 24 h, 2, 7, 14 and 28 days. Write counts below the detection limit as "<10".

3. Read the result

   The headline gives the outcome: "Meets USP <51> and Ph. Eur. criterion A".

   

4. Resolve alerts and download

   A failed criterion is critical. Missing organisms or time points, inoculum outside 10⁵–10⁶, testing above the lowest level and missing method suitability 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 · Study

2 · Counts

One row per organism. Inoculum and counts in cfu/mL (or per g). Write a count below the detection limit as "<10". Leave a time point empty if not tested.

5. Checks and alerts

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

• USP <51> category criteria and Ph. Eur. 5.1.3 criterion A or B.
• S. aureus, P. aeruginosa, C. albicans and A. brasiliensis (and E. coli where required).
• Inoculum level, lowest preservative level, method suitability, in-use testing.

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 <51>: "no increase" allows 0.5 log10. EU follows Ph. Eur. 5.1.3: criterion A is expected, B only where justified.

8. Working with other modules

• Preservative content is in the specification (Specification Builder) and its development in the Development Studio.

9. Common pitfalls

• Testing at the label claim rather than the lowest specified level.
• Missing the 6 h and 24 h counts needed for Ph. Eur. parenteral products.

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. Let C. albicans grow back

   Change the 28-day count of C. albicans from 9.0E3 to 9.0E4.

   Expected resultThe headline says Ph. Eur. criterion A is not met.