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PIC/S Guide to Good Manufacturing Practice for Medicinal Products

Self-Assess
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.

Verified

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 that map to 126 other frameworks. The largest domains are Complaints and Recall (1 controls), Documentation (1 controls), Outsourced Activities (1 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (9)

Complaints and Recall

1 controls
Controls in the Complaints and Recall domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-8Chapter 8: Complaints, Quality Defects, Product Recall

Documentation

1 controls
Controls in the Documentation domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity

Outsourced Activities

1 controls
Controls in the Outsourced Activities domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management

Personnel

1 controls
Controls in the Personnel domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training

Pharmaceutical Quality System

1 controls
Controls in the Pharmaceutical Quality System domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management

Premises and Equipment

1 controls
Controls in the Premises and Equipment domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration

Production

1 controls
Controls in the Production domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-5Chapter 5: Production Operations and Material Management

Quality Control

1 controls
Controls in the Quality Control domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-6Chapter 6: Quality Control, Testing, Batch Release

Self Inspection

1 controls
Controls in the Self Inspection domain of PIC/S Guide to Good Manufacturing Practice for Medicinal Products — 1 controls
CodeTitle
PICSGMP-9Chapter 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:

SWIFT CSCF

67%

6 controls mapped

Compare →

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration

67%

6 controls mapped

Compare →

IEC 62304:2015 Medical Device Software Lifecycle Processes

67%

6 controls mapped

Compare →

+ 123 more: ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (67%), Florida Digital Bill of Rights (FDBR) (56%)

See all 126 mapped frameworks ↓

Maps to 126 other frameworks

9 total controls
SWIFT CSCF
6 source controls mapped|4 target controls covered
67%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
6 source controls mapped|5 target controls covered
67%
IEC 62304:2015 Medical Device Software Lifecycle Processes
6 source controls mapped|7 target controls covered
67%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
6 source controls mapped|11 target controls covered
67%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|5 target controls covered
56%
SQF Code Edition 9 - Safe Quality Food
5 source controls mapped|4 target controls covered
56%
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|5 target controls covered
56%
South Korea ISMS-P
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%
PCI DSS 4.0
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%
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 2026
4 source controls mapped|1 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%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|2 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|4 target controls covered
44%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|6 target controls covered
44%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
44%
ISO/IEC 27043:2015
4 source controls mapped|2 target controls covered
44%
ISO 41001:2018 - Facility Management Systems
4 source controls mapped|4 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|3 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%
ISO/IEC 27003:2017
4 source controls mapped|6 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%
Kuwait National Cybersecurity Framework
4 source controls mapped|2 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 56002
4 source controls mapped|3 target controls covered
44%
NIST SP 800-190
4 source controls mapped|2 target controls covered
44%
ISO/SAE 21434
4 source controls mapped|2 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%
AS9100D - Aerospace Quality Management System
3 source controls mapped|5 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. 116/2025/QH15)
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%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
3 source controls mapped|2 target controls covered
33%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
33%
ISO/IEC 29115:2013 - Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
33%
FedRAMP Rev 5
3 source controls mapped|2 target controls covered
33%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
33%
Automotive SPICE (ASPICE) v4.1 - Process Assessment Model
3 source controls mapped|3 target controls covered
33%
COBIT 2019
3 source controls mapped|1 target controls covered
33%
Connecticut Data Privacy Act (CTDPA)
3 source controls mapped|1 target controls covered
33%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 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|2 target controls covered
33%
NIST SP 800-53 Rev 5
3 source controls mapped|6 target controls covered
33%
ISO/IEC 29134:2023
3 source controls mapped|1 target controls covered
33%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
33%
ISO/IEC 27400:2022
3 source controls mapped|1 target controls covered
33%
FedRAMP High
3 source controls mapped|1 target controls covered
33%
FedRAMP Moderate
3 source controls mapped|1 target controls covered
33%
21 CFR Part 211 - Current Good Manufacturing Practice
3 source controls mapped|4 target controls covered
33%
ISO/IEC 23837:2023
3 source controls mapped|1 target controls covered
33%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 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 No. 124/2024 on Personal Data Protection
3 source controls mapped|2 target controls covered
33%
ISO/IEC 30111:2019
3 source controls mapped|2 target controls covered
33%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
33%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
33%
DFARS 252.204-7012 - Safeguarding Covered Defense Information
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 27050-1:2019
3 source controls mapped|1 target controls covered
33%
Singapore AI Governance Framework
3 source controls mapped|2 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/IEC 27019:2024
2 source controls mapped|4 target controls covered
22%
FBI CJIS Security Policy
2 source controls mapped|1 target controls covered
22%
GAMP 5 - Good Automated Manufacturing Practice
2 source controls mapped|3 target controls covered
22%
21 CFR Part 58 - Good Laboratory Practice (GLP)
2 source controls mapped|1 target controls covered
22%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
22%
US Consumer Product Safety Act (CPSC) Manufacturer and Importer Duties
1 source controls mapped|2 target controls covered
11%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|1 target controls covered
11%
Vermont Data Privacy and Online Surveillance Act
1 source controls mapped|1 target controls covered
11%
ISO/TS 22317:2021
1 source controls mapped|1 target controls covered
11%
ISO/TS 22318:2021
1 source controls mapped|1 target controls covered
11%
ISO 50001:2018 - Energy Management Systems
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%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
11%
ISO 27799:2025
1 source controls mapped|1 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%
APRA CPS 234
1 source controls mapped|2 target controls covered
11%
BS 65000:2014 - Guidance on Organizational Resilience
1 source controls mapped|2 target controls covered
11%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|1 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 2019 (repealed edition)
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 30401
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 39001:2012 - Road Traffic Safety Management
1 source controls mapped|1 target controls covered
11%
ISO 45001:2018
1 source controls mapped|1 target controls covered
11%
Compare PIC/S Guide to Good Manufacturing Practice for Medicinal Products with SWIFT CSCF

Coverage is not the same as your position

This page shows what PIC/S Guide to Good Manufacturing Practice for Medicinal Products overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.

The Compliance Position Diagnostic, $5,000 fixed, ten business days

What is PIC/S Guide to Good Manufacturing Practice for Medicinal Products and who does it apply to?

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.

What does PIC/S Guide to Good Manufacturing Practice for Medicinal Products actually require?

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.

If I already comply with another framework, how much of PIC/S Guide to Good Manufacturing Practice for Medicinal Products do I already cover?

PIC/S Guide to Good Manufacturing Practice for Medicinal Products maps to 126 other compliance frameworks. The top mapping partners are SWIFT CSCF (67% coverage), ISO/IEC 17025:2017 - General Requirements for Testing and Calibration (67% coverage), IEC 62304:2015 Medical Device Software Lifecycle Processes (67% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

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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