# GMP SOP & Validation Author

> Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.



Tags: GMP, Pharmaceutical, FDA, Validation, Compliance


## Example Prompts

- Draft a GMP SOP for cleaning validation
- Complete IQ/OQ/PQ protocol with acceptance criteria
- Check that SOP and validation protocol have required elements

URL: https://rakenne.app/skills/gmp-sop-validation-author/index.md

Try this skill: https://rakenne.app/a/?skill=gmp-sop-validation-author



## Overview

Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.

## Getting Started

Add your source materials to the project workspace, then activate the *GMP SOP & Validation Author* skill. The agent will guide you through the process step by step.

## Example Conversation

> **You:** We need a cleaning validation SOP and an IQ/OQ protocol for our new filler.
>
> **Agent:** I'll draft the SOP (purpose, scope, procedure, records, references) and the validation protocol with acceptance criteria and traceability to the equipment.
>
> **You:** Run the validator. **Agent:** I ran `check_gmp_sop_validation_completeness`. SOP sections and validation acceptance criteria present. No warnings.

## Sample Output Excerpt

**SOP — Cleaning Validation.** Purpose: Define cleaning validation approach. Scope: Manufacturing equipment. Procedure: [steps]. Records: Validation report. **IQ Protocol — Filler XYZ.** Acceptance criteria: [list]. Traceability: Equipment ID, system boundaries.

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## Built-in Validation Tools

**check_gmp_sop_validation_completeness** checks for SOP sections (purpose, scope, procedure, records) and validation acceptance criteria and traceability. Run on SOP or validation document after drafting.


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