| name | gmp-sop |
| title | GMP Standard Operating Procedure |
| description | Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. Covers document control, role accountability, process controls, deviation/CAPA handling, and records management aligned to FDA CGMP (21 CFR 210/211), Part 11, ICH Q7/Q9/Q10, WHO GMP, PIC/S, and EU GMP. Use when creating or overhauling a GMP SOP, preparing for audits or inspections, or building compliance-ready procedures. Trigger: GMP, SOP, CGMP, 21 CFR 210, 21 CFR 211, Part 11, ICH Q7, ICH Q9, ICH Q10, WHO GMP, PIC/S, EU GMP. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/gmp-sop |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
GMP Standard Operating Procedure
Produces a GMP-compliant SOP that is inspection-ready and operationally executable.
Quick Start
- Gather inputs: process scope, applicable regulations, QMS context, equipment list, record systems.
- Walk through each SOP section below, filling tables and templates.
- Mark any unverified citations with
[VERIFY].
- Route for QA review and approval before release.
Prerequisites
Collect before drafting:
- Process scope — product type, dosage form, facility class, target markets
- Applicable regs — FDA CGMP, ICH, WHO, PIC/S, EU GMP, local requirements
- QMS context — document numbering, approval matrix, related SOPs
- Equipment — asset IDs, calibration/maintenance/qualification status
- Record systems — paper vs electronic, Part 11 status
- Inspection history — FDA 483s, warning letters, open CAPAs
- SME/approver list — production, QA, QC, engineering, management
SOP Sections
1. Document Control Page
| Field | Content |
|---|
| SOP Title | Precise scope (process/area) |
| SOP ID | Site numbering convention |
| Version | Numeric or semantic |
| Effective Date | Approved use date |
| Supersedes | Prior SOP ID/version |
| Prepared By | Name, role, date |
| Reviewed By | QA, SMEs |
| Approved By | QA/Management |
| Distribution | Controlled locations |
| Related SOPs | IDs and titles |
| Electronic Signatures | Part 11 status |
2. Purpose and Scope
Purpose:
This SOP establishes controlled steps for [process] to ensure GMP compliance under [reg citations].
Scope:
Applies to [areas, equipment, product types, personnel]. Excludes [exclusions with rationale].
Interfaces: [related SOP IDs].
3. Regulatory Basis
List only applicable regulations. Use [VERIFY] for unconfirmed citations.
