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PIC/S Guide to Good Manufacturing Practice for Medicinal Products
International (PIC/S — 54 member authorities)
v2024 (regularly updated)
9 domains
9 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.
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Framework Domains (9)
Complaints and Recall
1 controls
| Code | Title |
|---|---|
| PICSGMP-8 | Chapter 8: Complaints, Quality Defects, Product Recall |
Documentation
1 controls
| Code | Title |
|---|---|
| PICSGMP-4 | Chapter 4: Documentation - System, Record-Keeping, Data Integrity |
Outsourced Activities
1 controls
| Code | Title |
|---|---|
| PICSGMP-7 | Chapter 7: Outsourced Activities and Supplier Management |
Personnel
1 controls
| Code | Title |
|---|---|
| PICSGMP-2 | Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training |
Pharmaceutical Quality System
1 controls
| Code | Title |
|---|---|
| PICSGMP-1 | Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management |
Premises and Equipment
1 controls
| Code | Title |
|---|---|
| PICSGMP-3 | Chapter 3: Premises and Equipment - Design, Qualification, Calibration |
Production
1 controls
| Code | Title |
|---|---|
| PICSGMP-5 | Chapter 5: Production Operations and Material Management |
Quality Control
1 controls
| Code | Title |
|---|---|
| PICSGMP-6 | Chapter 6: Quality Control, Testing, Batch Release |
Self Inspection
1 controls
| Code | Title |
|---|---|
| PICSGMP-9 | Chapter 9: Self Inspection and Continuous Improvement |
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
78%
7 controls mapped
Compare →ISO/IEC 27003:2017
78%
7 controls mapped
Compare →SWIFT CSCF
67%
6 controls mapped
Compare →+ 137 more: ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (67%), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (67%)
See all 140 mapped frameworks ↓Maps to 140 other frameworks
9 total controls
AS9100D - Aerospace Quality Management System
7 source controls mapped|14 target controls covered
78%
ISO/IEC 27003:2017
7 source controls mapped|14 target controls covered
78%
SWIFT CSCF
6 source controls mapped|4 target controls covered
67%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
6 source controls mapped|17 target controls covered
67%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
6 source controls mapped|10 target controls covered
67%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
6 source controls mapped|12 target controls covered
67%
IEC 62304:2015 Medical Device Software Lifecycle Processes
6 source controls mapped|7 target controls covered
67%
BRCGS Global Standard for Food Safety Issue 9
6 source controls mapped|8 target controls covered
67%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
5 source controls mapped|8 target controls covered
56%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|2 target controls covered
56%
ISO/IEC 27006:2024
5 source controls mapped|7 target controls covered
56%
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|5 target controls covered
56%
21 CFR Part 58 - Good Laboratory Practice (GLP)
5 source controls mapped|3 target controls covered
56%
21 CFR Part 211 - Current Good Manufacturing Practice
5 source controls mapped|5 target controls covered
56%
ISO/IEC 25012:2008 - Data Quality Model
5 source controls mapped|3 target controls covered
56%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|3 target controls covered
44%
ISO 27005
4 source controls mapped|6 target controls covered
44%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|2 target controls covered
44%
Regulation on the European Health Data Space (EHDS)
4 source controls mapped|3 target controls covered
44%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|1 target controls covered
44%
ISO 37000:2021 - Governance of Organizations
4 source controls mapped|4 target controls covered
44%
ISO 19011
4 source controls mapped|3 target controls covered
44%
ISO 22320:2018
4 source controls mapped|4 target controls covered
44%
NIST Cybersecurity Framework 2.0
4 source controls mapped|7 target controls covered
44%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|4 target controls covered
44%
NIST AI Risk Management Framework (AI RMF 1.0)
4 source controls mapped|4 target controls covered
44%
ISO 20400:2017 - Sustainable Procurement
4 source controls mapped|7 target controls covered
44%
IEC 60601-1 - Medical Electrical Equipment Safety
4 source controls mapped|5 target controls covered
44%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|2 target controls covered
44%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|2 target controls covered
44%
ISO/IEC 27011:2024
4 source controls mapped|5 target controls covered
44%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|7 target controls covered
44%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
44%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
44%
ISO 27043
4 source controls mapped|2 target controls covered
44%
ISO 56002
4 source controls mapped|7 target controls covered
44%
ISO 41001:2018 - Facility Management Systems
4 source controls mapped|8 target controls covered
44%
ISO 39001:2012 - Road Traffic Safety Management
4 source controls mapped|8 target controls covered
44%
ISO 37002:2021 - Whistleblowing Management Systems
4 source controls mapped|6 target controls covered
44%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
4 source controls mapped|8 target controls covered
44%
ISO/IEC 23894:2023
4 source controls mapped|7 target controls covered
44%
ISO/IEC 27014:2020
4 source controls mapped|4 target controls covered
44%
IEC 62351 - Power Systems Communication Security
4 source controls mapped|2 target controls covered
44%
FFIEC IT Examination Handbook
4 source controls mapped|4 target controls covered
44%
AWS Well-Architected Security Pillar
4 source controls mapped|2 target controls covered
44%
PCI SSF
4 source controls mapped|4 target controls covered
44%
PCI PIN Security
4 source controls mapped|4 target controls covered
44%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
4 source controls mapped|2 target controls covered
44%
PCI P2PE
4 source controls mapped|4 target controls covered
44%
ISO 27017
4 source controls mapped|2 target controls covered
44%
NIST SP 800-190
4 source controls mapped|2 target controls covered
44%
Azure Security Benchmark
4 source controls mapped|2 target controls covered
44%
ISO/SAE 21434
4 source controls mapped|2 target controls covered
44%
ISO/IEC 38500:2024 - Governance of IT
4 source controls mapped|4 target controls covered
44%
ISO 27018
4 source controls mapped|2 target controls covered
44%
APRA CPS 234
4 source controls mapped|4 target controls covered
44%
OWASP SAMM
4 source controls mapped|2 target controls covered
44%
ICH Q10 - Pharmaceutical Quality System
4 source controls mapped|5 target controls covered
44%
FTC GLBA Safeguards Rule (16 CFR Part 314)
4 source controls mapped|2 target controls covered
44%
ISO 13485
3 source controls mapped|3 target controls covered
33%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
33%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|1 target controls covered
33%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|1 target controls covered
33%
ISO 31000:2018
3 source controls mapped|1 target controls covered
33%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
33%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
33%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
33%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|4 target controls covered
33%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
33%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
33%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
33%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
33%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
33%
ISO/IEC 27400:2022
3 source controls mapped|3 target controls covered
33%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
3 source controls mapped|3 target controls covered
33%
COBIT 2019
3 source controls mapped|1 target controls covered
33%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|3 target controls covered
33%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
33%
ISO/IEC 29134:2023
3 source controls mapped|3 target controls covered
33%
ISO 8000 - Data Quality
3 source controls mapped|2 target controls covered
33%
ISO/IEC 29147:2018
3 source controls mapped|3 target controls covered
33%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
33%
NIST SP 800-53 Rev 5
3 source controls mapped|6 target controls covered
33%
FedRAMP High
3 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Revision 5.1 HIGH
3 source controls mapped|1 target controls covered
33%
FedRAMP Moderate
3 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Rev 5 MODERATE
3 source controls mapped|1 target controls covered
33%
NIST SP 800-53 Rev 5 LOW
3 source controls mapped|1 target controls covered
33%
ISO/IEC 30111:2019
3 source controls mapped|3 target controls covered
33%
Nebraska Data Privacy Act
3 source controls mapped|2 target controls covered
33%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|2 target controls covered
33%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|2 target controls covered
33%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
33%
ASIS SPC.1-2009 - Organizational Resilience Standard
3 source controls mapped|1 target controls covered
33%
ISO 26262:2018 - Functional Safety for Road Vehicles
3 source controls mapped|1 target controls covered
33%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
33%
South Korea PIPA
3 source controls mapped|1 target controls covered
33%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|2 target controls covered
33%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
33%
ISO 26000:2010
2 source controls mapped|2 target controls covered
22%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
2 source controls mapped|1 target controls covered
22%
IEC 62443
2 source controls mapped|3 target controls covered
22%
Authorised Economic Operator (AEO) Programmes - Global Standards
2 source controls mapped|4 target controls covered
22%
NIST SP 1800-32
2 source controls mapped|3 target controls covered
22%
API 1164
2 source controls mapped|3 target controls covered
22%
APRA CPS 230 Operational Risk Management
2 source controls mapped|5 target controls covered
22%
ISO 27019
2 source controls mapped|4 target controls covered
22%
FBI CJIS Security Policy
2 source controls mapped|1 target controls covered
22%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
22%
Tennessee Information Protection Act (TIPA)
1 source controls mapped|1 target controls covered
11%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|1 target controls covered
11%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
11%
ISO 22317
1 source controls mapped|1 target controls covered
11%
ISO 22318
1 source controls mapped|1 target controls covered
11%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
11%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
11%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
11%
ISO 22316
1 source controls mapped|1 target controls covered
11%
NIST SP 800-171
1 source controls mapped|1 target controls covered
11%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
11%
ISO 27799
1 source controls mapped|1 target controls covered
11%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
1 source controls mapped|1 target controls covered
11%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
1 source controls mapped|3 target controls covered
11%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
11%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|4 target controls covered
11%
ISO 31000
1 source controls mapped|4 target controls covered
11%
BS 65000:2014 - Guidance on Organizational Resilience
1 source controls mapped|2 target controls covered
11%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
11%
ICAO Annex 17 - Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
11%
Aged Care Quality Standards (Australia)
1 source controls mapped|4 target controls covered
11%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
11%
ISO 9001
1 source controls mapped|3 target controls covered
11%
ISO 30401
1 source controls mapped|1 target controls covered
11%
ISO 55001
1 source controls mapped|1 target controls covered
11%
ISO 22000
1 source controls mapped|1 target controls covered
11%
ISO 37001
1 source controls mapped|1 target controls covered
11%
FDA Quality Management System Regulation (QMSR)
1 source controls mapped|1 target controls covered
11%
COSO Internal Control - Integrated Framework (2013)
1 source controls mapped|2 target controls covered
11%
ISO 45001
1 source controls mapped|1 target controls covered
11%
ISO 37301
1 source controls mapped|1 target controls covered
11%
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 9 domains and 9 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 9 controls organised across 9 domains. The largest domains are Complaints and Recall (1 controls), Documentation (1 controls), Outsourced Activities (1 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 140 other compliance frameworks. The top mapping partners are AS9100D - Aerospace Quality Management System (78% coverage), ISO/IEC 27003:2017 (78% coverage), SWIFT CSCF (67% 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 9 controls and track your progress.
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