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