GMP Standard Operating Procedure

gmp-sop

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.

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SKILL.md

Full skill instructions

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.

Authority	Citation
FDA CGMP	21 CFR Parts 210/211
Electronic records	21 CFR Part 11
ICH	Q7 (API), Q9, Q10
WHO	TRS GMP guidance
PIC/S	GMP Guide
EU	EU GMP Guide + Annexes

4. Definitions

Provide GMP-aligned definitions consistent with site QMS. Minimum set: CPP, CQA, deviation, OOS, OOT, batch record, validation, qualification, calibration.

5. Responsibilities Matrix

Role	Duties	Decisions/Approvals	Records Owned
Production	Execute SOP steps	Stop work for deviations	Batch records
QA	Approve SOP, review deviations	Release/closure authority	QA review logs
QC	Testing, sampling	OOS disposition	Lab records
Engineering	Maintenance/calibration	Equipment readiness	PM/calibration logs
Management	Resource allocation	Final approval	Training matrix

6. Materials, Equipment, and Utilities

Item	ID/Spec	Qualification	Calibration/PM	Acceptance Criteria
Equipment	Asset ID	IQ/OQ/PQ status	Frequency	Tolerance
Materials	Grade/spec	Supplier status	Storage	COA required
Utilities	Water/HVAC/gases	Monitoring	Limits	Action levels

7. Procedure Steps

Each step must specify role, action, records, and acceptance criteria.

Step	Role	Action	CPP/CQA	Hold Point	Records
1	Production	[imperative action]	[range]	QA if required	[record]
2	QC	[sample/test]	[spec]	QA review	[record]
3	QA	[verification]	N/A	Release	[record]

Step rules:

Include decision points and stop-work criteria
Define acceptance ranges for all CPPs/CQAs
State required PPE/cleanroom behavior where applicable
Require documentation at time of action (concurrent recording)

8. In-Process Controls

Control	Frequency	Method	Acceptance	Action if OOR
[Control]	[per batch/time]	[method]	[spec]	[action]

9. Deviations, OOS/OOT, and CAPA

Document deviation within same shift or defined timeframe
Quarantine affected material/lots
Initiate root cause investigation
Assess impact on product quality and patient safety
Implement CAPA with effectiveness checks
Document QA disposition and release decision

10. Documentation and Records

Record	Owner	System	Review Timeline	Retention
Batch record	Production	Paper/eQMS	[timeframe]	Per 21 CFR 211.180 `[VERIFY]`
Calibration log	Engineering	Paper/eQMS	[timeframe]	[policy]
Training record	QA/HR	LMS/eQMS	[timeframe]	[policy]

If electronic: require validation, audit trails, access control, e-signatures per Part 11.

11. Training and Qualification

Initial training before first execution
Retraining on each revision
Qualification for roles with critical steps
Document training effectiveness

12. Change Control and Revision History

Version	Effective Date	Change Summary	Rationale	Approvers
1.0	[date]	Initial release	[reason]	[names]

13. References

List all cited standards with version/date. Mark uncertain items [VERIFY].

14. Appendices

Include controlled templates: SOP execution checklist, batch record template, deviation report template, in-process control log, equipment cleaning log.

Pitfalls and Checks

Language — use imperative, unambiguous phrasing; never advisory ("should consider")
Citations — verify all regulatory citations are current; mark uncertain ones [VERIFY]
Role segregation — maintain separation between production and QA/QC functions
Retention — apply the strictest applicable retention requirement across jurisdictions
Jurisdiction — add annexes for non-U.S. markets (EU, WHO, PIC/S requirements)
Part 11 — confirm electronic record controls whenever eQMS or e-signatures are used

Install skill

Copy and run in your terminal

npx -y skills add https://github.com/CaseMark/skills --skill gmp-sop

View on GitHub

skills/legal/gmp-sop/SKILL.md

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