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.

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.