Development Studio

1. What this module does

The module turns your development data into the story a reviewer expects under ICH Q8(R2), Q9 and Q10: the quality target product profile, which attributes are critical and why, the risk assessment, the studies that set ranges, and how each critical attribute is controlled.

It scores the FMEA (risk priority number = severity × occurrence × detectability), ranks the risks, links each critical attribute to its control, and flags gaps a reviewer would ask about.

What you get

• Word or PDF files for 3.2.P.2.1, 2.2, 2.3, 2.5 and 2.6 (or 3.2.S.2.6).
• A summary file for the QOS Composer & Dossier Assembler.

2. Before you start

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

• The QTPP: dosage form, route, strength, release profile, stability and so on, with the target and justification of each.
• The quality attributes, which are critical, why, and what controls them.
• The FMEA: factor, failure mode, severity, occurrence and detectability scored 1 to 10, and the mitigation.
• DoE or other studies with the range studied, the effect and the proven acceptable range.
• Excipient compatibility results, clinical formulations and how they bridge to the commercial one, and summaries of formulation, dissolution method and process development.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/development-studio.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. Set the scope

   Choose Section: drug product (3.2.P.2) or drug substance process development (3.2.S.2.6). For a drug product choose the dosage form type and the BCS class, and tick Multi-dose or preserved product if it applies. Tick Design space claimed only if you claim one.

   

2. Enter the QTPP and CQAs

   Enter the QTPP and the quality attributes. For each critical attribute give the control (for example "Specification (assay)" or "Blend uniformity IPC").

3. Enter the risk assessment and studies

   Enter the FMEA rows and the DoE results. The headline shows 5 critical quality attributes and 2 high risks, the highest being granulation water amount on dissolution (RPN 160).

   

4. Read the ranked risks

   The risk table is sorted by RPN, and the CQA table shows each critical attribute with its control. High risks without mitigation are flagged.

   

5. Resolve alerts

   The example has two major alerts (a critical attribute with no control, and a high RPN with no mitigation) and two minor ones. Fix them in the tables or justify them.

   

6. Preview and download

   Preview each 3.2.P.2 section, check the review, and download Word or PDF.

   

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

2 · QTPP and critical quality attributes

3 · Risk assessment and studies

4 · Formulation and process development (3.2.P.2.1–2.3) shown when it applies

5 · Microbiological attributes and compatibility (3.2.P.2.5, 2.6) shown when it applies

6 · Drug substance process history (3.2.S.2.6) shown when it applies

5. Checks and alerts

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

• At least one attribute is critical; every critical attribute has a control and appears in the risk assessment.
• FMEA scores are 1 to 10; risks with a high RPN, or a severity of 9 or 10, need a mitigation.
• If a design space is claimed, studies are listed; each study gives a proven acceptable range.
• Drug substance and excipient compatibility data; any change seen in compatibility is flagged.
• Clinical formulations listed, with bridging for any that differ from the commercial formulation; formulation, dissolution method and process development summaries present.
• Multi-dose products need preservative effectiveness data; microbiological attributes are discussed.
• Drug substance (3.2.S.2.6): process versions listed with a comparability discussion when there are several.

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: 3.2.P.2.1 Components of the drug product; 3.2.P.2.2 Drug product (formulation development); 3.2.P.2.3 Manufacturing process development; 3.2.P.2.5 Microbiological attributes; 3.2.P.2.6 Compatibility; 3.2.S.2.6 Manufacturing process development. 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

The development sections follow ICH Q8(R2) in both regions. In EU mode, references are cited as EMA and Ph. Eur. (for example Ph. Eur. 5.1.3 for efficacy of antimicrobial preservation instead of USP <51>). 3.2.P.2.4 (container closure suitability) is written by the Container Closure & E&L.

8. Working with other modules

• Add the Specification Builder summary to cross-check controls.
• Critical steps and parameters should match the Process & Controls Writer.
• The QOS Composer & Dossier Assembler summarises the control strategy in 2.3.P.2.

9. Common pitfalls

• Scoring every risk the same. The ranking only helps when severity, occurrence and detectability are scored honestly.
• Listing an attribute as critical but naming no control, or controlling it by "testing" without saying which test.
• Claiming a design space without the studies that define it.
• Forgetting to bridge an early clinical formulation (for example a capsule) to the commercial tablet.

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. Flag a multi-dose product

   Tick Multi-dose or preserved product.

   Expected resultA major alert says a multi-dose product needs preservative effectiveness data.

2. Claim a design space without studies

   Tick Design space claimed, then clear the Design of experiments and other studies table.

   Expected resultA major alert says a design space is claimed but no studies are listed.