GMP quality reports · Training guide
Media Fill (APS) Report
Write the aseptic process simulation report: units filled, incubated and contaminated in each run, the interventions simulated and the outcome against EU Annex 1 and the FDA aseptic processing guidance.
Open the tool at https://app.cmcfy.com/app/media-fill.html. This guide is also online at https://cmcfy.com/guides/media-fill.html
1. What this module does
You enter each run with the units filled, removed and incubated, contaminated units, duration and operators, and the interventions performed. The tool applies the criteria for the regions you choose.
EU: any contaminated unit fails the run. FDA: under 5,000 units no contaminated unit is allowed; above that, one unit means investigation and two mean revalidation. It also checks duration, interventions, incubation and growth promotion.
What you get
- A Word or PDF report: Aseptic process simulation report.
2. Before you start
Have these ready. You can still start with the example data and replace it piece by piece.
- Run data: units filled, removed with justification, incubated and contaminated.
- Interventions required and performed in each run.
- Incubation conditions, growth promotion and EM results during the runs.
3. Step by step with the example
Open the tool at app.cmcfy.com/app/media-fill.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.
Describe the line
Enter the line, the container and fill, the medium, and whether these runs are initial qualification or periodic requalification.
Enter runs and interventions
One row per run. One row per intervention with the number required and the number performed in each run, separated by ";".
Read the result
The headline gives the outcome: "2 runs · 20,615 units · no contaminated units".
Runs and interventions. Resolve alerts and download
A contaminated unit is critical. Runs shorter than the longest batch, interventions not performed, short incubation and too few runs for initial qualification 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 · Line and design
| Field | What to enter |
|---|---|
| Filling line and process | Type it in. |
| Regulations | Choose one: US: FDA aseptic guidance (2004); EU: EU GMP Annex 1 (2022); Both US and EU. |
| Report number | Type it in. |
| Type of runs | Choose one: Initial qualification (three consecutive runs); Periodic requalification. |
| Longest commercial batch duration (h) | Type a number. |
| Largest commercial batch (units) | Type a number. |
| Medium and growth promotion | Type it in. |
| Incubation | Type it in. |
2 · Runs
One row per run. Units removed must be justified (for example non-integral units) in the protocol.
| Field | What to enter |
|---|---|
| Runs | A table. Columns: Run | Date | Shift | Units filled | Units removed (justified) | Units incubated | Contaminated units | Duration (h) | Operators. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
| Interventions | List the count for each run in the same order as the runs table. A table. Columns: Intervention | Type (inherent/corrective) | Required per run | Performed in each run (";"). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
| Identification of any contaminants and investigation | Type or paste text. |
3 · Personnel and environment
| Field | What to enter |
|---|---|
| All operators authorised for aseptic work took part in an APS in the last 12 months | Tick the box if it applies. |
| Environmental and personnel monitoring during the runs | Type or paste text. |
| Inspection of incubated units by trained staff, with defect and positive controls | Tick the box if it applies. |
5. Checks and alerts
Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:
- Contaminated units against EU and FDA criteria.
- Run duration against the longest commercial batch; interventions at routine frequency.
- Incubation, growth promotion, inspection and operator participation.
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: Results 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
- 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.
- 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).
- Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
- 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.
- 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
| Section | Document |
|---|---|
| Report | Aseptic process simulation report |
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
EU follows EU GMP Annex 1 (2022) 9.32–9.49: the target is zero and any contaminated unit fails. US follows the FDA aseptic processing guidance (2004) section IX.
8. Working with other modules
- Environmental monitoring during the runs is trended in the Environmental Monitoring Trend Report report.
9. Common pitfalls
- Simulating fewer interventions than happen in routine production.
- Runs shorter than the longest commercial batch.
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.
Find a contaminated unit
Change the contaminated units in run APS-2026-03 from 0 to 1.
Expected resultThe headline shows one run failed.