PIC/S Guide to Good Manufacturing Practice for Medicinal Products
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) provides internationally harmonised GMP guidelines for medicinal product manufacturing. PIC/S has 54 participating authorities worldwide. The guide covers quality management, personnel, premises, equipment, documentation, production, quality control, outsourced activities, complaints, self-inspection, and computerised systems. The PIC/S GMP guide is largely harmonised with the EU GMP guide and WHO GMP guidelines. Annexes cover specific product types and activities.
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Framework Domains (26)
Batch Release
| Code | Title |
|---|---|
| PICS-AUTHORISED-PERSON | Authorised Person Certification |
Change Management
| Code | Title |
|---|---|
| PICS-CHANGE-CONTROL | Change Control |
Chapter 1 - Pharmaceutical Quality System
| Code | Title |
|---|---|
| PICS-GMP-1.1 | Quality Management System |
| PICS-GMP-1.2 | Good Manufacturing Practice |
| PICS-GMP-1.3 | Quality Risk Management |
| PICS-GMP-1.4 | Product Quality Review |
Chapter 2 - Personnel
| Code | Title |
|---|---|
| PICS-GMP-2.1 | Qualified Personnel |
| PICS-GMP-2.2 | Key Personnel Responsibilities |
| PICS-GMP-2.3 | Training |
Chapter 3 - Premises and Equipment
| Code | Title |
|---|---|
| PICS-GMP-3.1 | Premises Design |
| PICS-GMP-3.2 | Equipment Qualification |
Chapter 4 - Documentation
| Code | Title |
|---|---|
| PICS-GMP-4.1 | Documentation System |
| PICS-GMP-4.2 | Record Keeping |
Chapters 5-6 - Production and Quality Control
| Code | Title |
|---|---|
| PICS-GMP-5.1 | Production Operations |
| PICS-GMP-6.1 | Quality Control Testing |
| PICS-GMP-6.2 | Batch Release |
Chapters 7-9 - Outsourcing, Complaints, Self-Inspection
| Code | Title |
|---|---|
| PICS-GMP-7.1 | Outsourced Activities |
| PICS-GMP-8.1 | Complaints and Product Recall |
| PICS-GMP-9.1 | Self Inspection |
Computerised Systems
| Code | Title |
|---|---|
| PICS-ANNEX-11 | Computerised Systems |
Continuous Improvement
| Code | Title |
|---|---|
| PICS-PQR | Product Quality Review |
Data Integrity
| Code | Title |
|---|---|
| PICS-DATA-INTEGRITY | Data Integrity |
Distribution
| Code | Title |
|---|---|
| PICS-WAREHOUSING-DISTRIBUTION | Storage, Handling, and Distribution |
Documentation
| Code | Title |
|---|---|
| PICS-DOCUMENTATION | Documentation System |
Facilities
| Code | Title |
|---|---|
| PICS-PREMISES-EQUIPMENT | Premises and Equipment Design |
Governance
| Code | Title |
|---|---|
| PICS-SELF-INSPECTION | Self Inspection Programme |
Incident Response
| Code | Title |
|---|---|
| PICS-COMPLAINTS-RECALL | Complaints, Quality Defects, and Recalls |
Manufacturing
| Code | Title |
|---|---|
| PICS-PRODUCTION | Production Controls |
Personnel
| Code | Title |
|---|---|
| PICS-PERSONNEL | Personnel Responsibilities and Training |
Quality Control
| Code | Title |
|---|---|
| PICS-QC | Quality Control and Sampling |
Quality Events
| Code | Title |
|---|---|
| PICS-DEVIATION-CAPA | Deviation and CAPA Management |
Quality Management
| Code | Title |
|---|---|
| PICS-PQS | Pharmaceutical Quality System |
Risk Management
| Code | Title |
|---|---|
| PICS-QRM | Quality Risk Management |
Sterile Manufacturing
| Code | Title |
|---|---|
| PICS-ANNEX-1 | Manufacture of Sterile Products |
Supply Chain
| Code | Title |
|---|---|
| PICS-MATERIAL-MANAGEMENT | Material Management and Supplier Qualification |
Third Party
| Code | Title |
|---|---|
| PICS-OUTSOURCED | Outsourced Activities |
Validation
| Code | Title |
|---|---|
| PICS-EQUIPMENT-QUALIFICATION | Equipment Qualification and Calibration |
| PICS-PROCESS-VALIDATION | Process Validation |
Your Compliance Coverage
If you comply with PIC/S Guide to Good Manufacturing Practice for Medicinal Products, you already cover:
AS9100D — Aerospace Quality Management System
26%
10 controls mapped
Compare →ISO/IEC 27003:2017
26%
10 controls mapped
Compare →AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
26%
10 controls mapped
Compare →+ 561 more: SQF Code Edition 9 — Safe Quality Food (24%), ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (24%)
See all 564 mapped frameworks ↓Maps to 564 other frameworks
Frequently Asked Questions
What is PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
PIC/S Guide to Good Manufacturing Practice for Medicinal Products is a compliance framework from International (PIC/S — 54 member authorities) with 26 domains and 38 controls. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) provides internationally harmonised GMP guidelines for medicinal product manufacturing. PIC/S has 54 participating authorities worldwide. The guide covers quality management, personnel, premises, equipment, documentation, production, quality control, outsourced activities, complaints, self-inspection, and computerised systems. The PIC/S GMP guide is largely harmonised with the EU GMP guide and WHO GMP guidelines. Annexes cover specific product types and activities. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does PIC/S Guide to Good Manufacturing Practice for Medicinal Products have?
PIC/S Guide to Good Manufacturing Practice for Medicinal Products has 38 controls organised across 26 domains. The largest domains are Chapter 1 - Pharmaceutical Quality System (4 controls), Chapter 2 - Personnel (3 controls), Chapters 5-6 - Production and Quality Control (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does PIC/S Guide to Good Manufacturing Practice for Medicinal Products map to?
PIC/S Guide to Good Manufacturing Practice for Medicinal Products maps to 564 other compliance frameworks. The top mapping partners are AS9100D — Aerospace Quality Management System (26% coverage), ISO/IEC 27003:2017 (26% coverage), AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence (26% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with PIC/S Guide to Good Manufacturing Practice for Medicinal Products compliance?
Start your PIC/S Guide to Good Manufacturing Practice for Medicinal Products compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about PIC/S Guide to Good Manufacturing Practice for Medicinal Products requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 38 controls and track your progress.
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