Frameworks / PIC/S Guide to Good Manufacturing Practice for Medicinal Products / PICSGMP-7 PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Outsourced Activities
PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-7: Chapter 7: Outsourced Activities and Supplier Management Per PIC/S GMP Chapter 7: outsourced activities. Requirements include (a) implement Outsourced Activities controls including written agreement + Quality Agreement + (b) qualify contract acceptors including initial + ongoing assessment + audits + (c) maintain communication + change control between contract giver + acceptor + (d) maintain Material Management and Supplier Qualification for all categories of suppliers + (e) implement ongoing oversight including periodic audit + performance review + (f) maintain documentation of outsourcing arrangements + Quality Agreements + (g) ensure contract acceptor compliance with GMP.
Maintained by Gerard Blokdyk · Verified against the published standard 31 May 2026 · Control text last updated 21 May 2026 What else in your programme already covers this This control maps to 211 controls across 106 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
A.1 Point-of-Care Testing Additional Requirements ISO-15189-5.1 Legal entity ISO-15189-5.4 Structure and authority ISO-15189-6.7 Service agreements ISO-15189-6.8 Externally provided products and services ISO-20400-4.2 Principles of sustainable procurement ISO-20400-7.2 Integrating sustainability into specifications ISO-20400-7.3 Supplier selection ISO-20400-7.4 Contract management and review ISO-20400-7.5 Reviewing and learning NIST-CSF-DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria NIST-CSF-GV.SC-01 A cybersecurity supply chain risk management program, strategy, objectives, policies, and processes are established and agreed to by organizational stakeholders NIST-CSF-ID.AM-04 Inventories of services provided by suppliers are maintained NIST-CSF-ID.RA-10 Critical suppliers are assessed prior to acquisition NIST-CSF-PR.AA-05 Access permissions, entitlements, and authorizations are defined in a policy, managed, enforced, and reviewed, and incorporate the principles of least privilege and separation of duties ISO23894-1 Scope of AI Risk Management ISO23894-3 AI-Specific Terminology ISO23894-6.2 Scope, Context and Criteria ISO23894-A.6 AI System Security API1164-21 TSA Pipeline Security Directive Alignment API1164-22 Configuration management for OT systems API1164-23 Change management procedures AEO-2 Demonstrated Compliance with Customs Requirements AEO-4 Financial Viability P2-S1 Partnership ACQ.4 Supplier Monitoring MLE.1 Machine Learning Requirements Analysis MLE.3 Machine Learning Training IEC62304-5.2 Software Requirements Analysis IEC62304-5.3 Software Architectural Design IEC62304-7.2 Risk Control Measures IEC62443-21 Supply chain risk management for critical components IEC62443-22 Configuration management for OT systems IEC62443-23 Change management procedures ISO-19650-1-4 Information management concepts ISO-19650-1-7 Common Data Environment (CDE) concept ISO-19650-3-5.3 Trigger events for information exchange ISO-22320-5.1 General process requirements ISO-22320-5.3 Incident management structure (command) ISO-22320-5.4 Roles and responsibilities ISO28001-PC-03 Supply Chain Incident Reporting ISO28001-PC-04 Supply Chain Continuity Planning ISO28001-PI-01 Personnel Security Screening ISO-41001-4.1 Understanding the organization and its context ISO-41001-4.3 Determining the scope of the FM management system ISO-41001-8.4 Control of outsourced processes and services ISO27003-4.2 Understanding the needs and expectations of interested parties ISO27003-4.3 Determining the scope of the information security management system ISO27003-8.1 Operational planning and control 27004-3 Terms and definitions 27004-A.2 Patching and Vulnerability Measures 27004-B.1 Example measurement definitions 27011-1 Scope 27011-3 Terms and definitions 27011-5.6 Supplier relationships and telecom supply chain ISO27019-22 Configuration management for OT systems ISO27019-23 Change management procedures ISO27019-24 Vulnerability assessment for critical systems 27557-1 Scope 27557-3 Terms and definitions 27557-6.2 Scope, context, and criteria for privacy 29100-1 Scope 29100-3 Terms and definitions 29100-4.1 Actors and roles CFR211-A-3 Section 211.3 - Definitions CFR211-J-184 Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records 58.1 Scope 58.3 Definitions CPS230-27 Identification and Escalation of Incidents and Near Misses CPS230-49 Internal Audit Review of Proposed Critical Operation Outsourcing AL-DPA-1 Scope and Definitions AL-DPA-3 Lawful Basis for Processing AT-DSG-2 Section 2 - Scope and application AT-DSG-8 Section 22 - Functions and powers of the DPA CPG-6.A Vendor and Supplier Incident Reporting CPG-6.B Supply Chain Incident Reporting DA-1 Enterprise Data Architecture DIQ-2 Data Quality Management FEDRAMP-CM-6 Configuration Settings FEDRAMP-CP-9 System Backup FDBR-702 Definitions (§501.702) FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704) Sapin2-Pillar1-Code-of-Conduct Pillar 1 - Anti-Corruption Code of Conduct Sapin2-Pillar4-ThirdParty-DueDiligence Pillar 4 - Third-Party Due Diligence (Clients, Suppliers, Intermediaries, M&A) 60601-1.3 Terminology and definitions 60601-1.4.1 General requirements ISO-56002-4.3 Determining the scope of the innovation management system ISO-56002-8.3.4 Develop solutions ISO8000-DQM-02 Data Quality Dimensions ISO8000-MDG-03 Continuous Improvement ISO-17025-5.1 Legal entity ISO-17025-5.4 Personnel for the management system ISO-25012-5.2 Defining data quality measures ISO-25012-5.3 Planning and performing data quality evaluations 27014-1 Scope 27014-3 Terms and definitions 29147-3 Terms and definitions 29147-9.2 Contact mechanisms and scope 30111-3 Terms and definitions 30111-5.1 Organizational policy STANAG-1 STANAG 4774 Confidentiality Label Schema and XML Structure STANAG-2 STANAG 4778 Metadata Binding Mechanism and Cryptographic Binding NDPA-2 Consumer Rights - Access, Correct, Delete, Portability, Appeal NDPA-5 Privacy Notice, Data Minimisation, and Purpose Limitation PICERL-P2 Risk Assessment PICERL-P3 CSIRT Formation C1 Organizational Boundary C3 Scope 1 and 2 Coverage IM8-RES.2 Disaster Recovery IM8-TPM.4 Supply Chain Risk Management ISMSP-PI-03 Third-Party Provision and Outsourcing ISMSP-SYS-04 Vulnerability Management USMCADIGITAL-1 Cross-Border Data Flows and Localisation USMCADIGITAL-4 Government Data, Cybersecurity, Interoperability AS9100D-8.4 Control of Externally Provided Processes, Products, Services 4.4.1 Resources, Roles, Responsibility, and Authority AWWA-1.1 Security Policy and Governance AZ-DPA-2 Article 2 - Basic Concepts Mat 03 Responsible Sourcing of Materials COBIT-BAI02 Managed requirements definition CJIS-19 Supply Chain Risk Management FFIEC-05 Roles and responsibilities definition FTC-Safeguards-Scope-Defs Scope, Definitions and Financial Institution Applicability (16 CFR 314.1, 314.2) CA-9 Internal System Connections CA-9 Internal System Connections ICP-1 Objectives, Powers and Responsibilities of the Supervisor 62351-2 Glossary of terms ISO-14064-1-5.1 Organizational boundaries ISO22316-14 Supply chain continuity ISO-26000-6.6 Fair operating practices ISO-26262-3-5 Item definition ISO-50001-8.3 Procurement 27007-5.2 Audit Programme Objectives 27010-15.1 Incident Management ISO27043-04 Roles and responsibilities definition 27050-1.4 Terms and definitions 27400-3 Terms and definitions 29115-3 Terms and definitions 29134-3 Terms and definitions ISO21434-04 Roles and responsibilities definition ISO22317-14 Supply chain continuity ISO22318-14 Supply chain continuity BIPA-SEC5-1 Biometric Identifier Definition OWASPSAMM-1 Governance: Strategy, Policy, Compliance, Education, Champions 2.2.2 2.2.2 Vendor default accounts managed PCI-P2PE-05 Roles and responsibilities definition PCI-PIN-05 Roles and responsibilities definition PCI-SSF-05 Roles and responsibilities definition PHILCC-1 Computer Crime Offences (Illegal Access, Interference, Misuse of Devices) PSPF24-1 Security Culture, Governance, Risk Management EHDSREG-1 Mandatory Requirements for EHR Systems (Articles 14-29) SWIFTCSCF-1 Restrict Internet Access and Protect Critical Systems (Objective 1) PIPA-Data-Subject-Rights-Access-Correction-Erasure-Portability-Automated-Decisions-Articles-35-37-2 Korea PIPA Data Subject Rights + Access + Correction + Erasure + Portability + Article 35-37 GT-3 Supply Chain Compromise FADP-5 Definitions (Article 5) TEFCAREC-1 Common Agreement Conformance and Onboarding OB-OPS.2 Performance Standards 15 U.S.C. § 78dd-2(h) Definition of Domestic Concern VERMONTAICDA-4 Vermont AG Enforcement and Cure VIETNAMCYBER-2 Prohibited Acts (Access, Interception, Forgery, Content) W3CVCDM-1 Three-Party Ecosystem (Issuer, Holder, Verifier) Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected .
Query this from an agent The graph holds this control, the 211 it maps to, and the evidence behind each claim, over MCP and REST.