Process Validation Report

1. What this module does

You enter the PPQ batches, the quality attribute results (several results per batch where the protocol samples more than once, for example blend uniformity locations) and the recorded range of each critical process parameter. The tool checks each result and parameter against its limit and calculates the mean, standard deviation and Ppk of each attribute across all PPQ results, and the spread within each batch.

It writes the PPQ report with a chart of the attribute you choose, tables of results and parameters, the discussion, the continued process verification plan and the conclusion. A failure or excursion blocks the report until you record the investigation.

What you get

• A Word or PDF report: Process performance qualification report, with sign-off lines.
• A summary file for the QOS Composer & Dossier Assembler with each attribute's Ppk.

2. Before you start

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

• The approved PPQ protocol (number, number of batches, acceptance criteria and any capability criterion).
• Each batch: date, size, scale, yield, deviations and disposition.
• Results for each attribute and batch, and the lowest and highest value recorded for each critical process parameter.
• Deviation summaries, hold times and the continued process verification plan.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/process-validation-report.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 study

   Enter the product, the regulations (US, EU or both), the product type, the report and protocol numbers, the process and scale, and the number of batches the protocol requires. In EU mode choose the validation approach.

   

2. Enter batches, results and parameters

   One row per batch. Results go one row per attribute and batch, with several results in one cell separated by ";". Process parameters go one row per parameter and batch, with the range and the lowest and highest value recorded. Excel, CSV, Word, PDF and scanned tables can be loaded.

3. Read the result

   The headline says whether every result met its criterion: "3 PPQ batches · all 66 results within criteria". The capability table gives Ppk per attribute; values from fewer than 10 results are marked with an asterisk, because they are an indication only.

   

4. Resolve alerts and download

   A result outside its criterion is critical: record the investigation reference and outcome. Excursions, missing batches, low Ppk, blend uniformity RSD above 5% and a missing CPV plan are flagged. 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 · Study

2 · PPQ batches

3 · Quality attribute results

One row per batch and attribute. Put several results for the same batch in one cell separated by ";" (for example blend uniformity locations). Leave a limit empty if there is none.

4 · Process parameters

5 · Deviations, hold times and continued verification

5. Checks and alerts

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

• Every result against its lower and upper limit; a failure is critical and must be recorded with its investigation.
• Mean, standard deviation and Ppk per attribute across all PPQ results; Ppk below 1.0 (major) or below the protocol criterion (minor); fewer than 10 results noted.
• Within-batch spread per batch; blend uniformity RSD above 5% flagged (ASTM E2709 / E2810 practice).
• Each critical process parameter against its range in every batch.
• Number of batches against the protocol (three consecutive for EU traditional validation), commercial scale, yield criterion, disposition, deviations with references and a discussion.
• Continued process verification plan and hold times present; HCP and DNA results for biologics; sterility assurance referenced for sterile products.

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 discussion; 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 mode follows the FDA Process Validation guidance (2011): stage 2 process qualification and stage 3 continued process verification. EU mode follows EU GMP Annex 15 and the EMA process validation guideline: traditional validation on at least three consecutive batches, continuous process verification, or a hybrid, followed by ongoing process verification.

8. Working with other modules

• Write the protocol first in the Protocol Builder (Process validation (PPQ)); the approved protocol is compared with this report in the preview.
• The summary of validation for 3.2.P.3.5 or 3.2.S.2.5 is written in the Process & Controls Writer or the Biologics Process Writer module.
• A failure is investigated in the Investigation Studio (OOS, deviation, CAPA).
• The PPQ data feed the trends in the Annual Product Review.

9. Common pitfalls

• Entering only the batch mean for attributes sampled at many locations: Ppk then rests on three numbers.
• Leaving the limit empty for an attribute that has one.
• Treating Ppk from three results as proof of capability; continue to assess it in CPV.

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. Introduce a failing result

   In the results table, change the assay of PPQ-02 from 100.4 to 94.5.

   Expected resultThe headline shows one result outside criteria.

2. Raise the capability criterion

   Set Ppk criterion in the protocol to 3.5.

   Expected resultThe result note says Ppk for tablet hardness and dissolution is below 3.5.