Frameworks / PIC/S Guide to Good Manufacturing Practice for Medicinal Products / PICSGMP-2 PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Personnel
PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-2: Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training Per PIC/S GMP Chapter 2: personnel + training. Requirements include (a) ensure adequate Qualified Personnel with appropriate qualifications + experience + (b) define Key Personnel Responsibilities including Head of Production + Head of Quality Control + Qualified Person (QP) per applicable jurisdiction + (c) implement initial + continuing Training including GMP + role-specific + hygiene + (d) maintain training records + competency assessment + (e) implement health monitoring + hygiene practices + clean clothing + (f) implement conflict of interest + personal hygiene policies + (g) maintain organisational chart + reporting lines.
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 146 controls across 86 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
IEC62304-5.2 Software Requirements Analysis IEC62304-5.3 Software Architectural Design IEC62304-7.2 Risk Control Measures ISO-15189-5.1 Legal entity ISO-15189-5.4 Structure and authority ISO-15189-6.7 Service agreements 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 ISO23894-1 Scope of AI Risk Management ISO23894-3 AI-Specific Terminology ISO23894-6.2 Scope, Context and Criteria 27004-3 Terms and definitions 27004-A.2 Patching and Vulnerability Measures 27004-B.1 Example measurement definitions 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 58.1 Scope 58.3 Definitions 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 MLE.1 Machine Learning Requirements Analysis MLE.3 Machine Learning Training 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) 60601-1.3 Terminology and definitions 60601-1.4.1 General requirements ISO-20400-4.2 Principles of sustainable procurement ISO-20400-7.2 Integrating sustainability into specifications ISO-41001-4.1 Understanding the organization and its context ISO-41001-4.3 Determining the scope of the FM management system 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 27011-1 Scope 27011-3 Terms and definitions 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 NIST-CSF-DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria 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 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 CFR211-A-3 Section 211.3 - Definitions 4.4.1 Resources, Roles, Responsibility, and Authority AWWA-1.1 Security Policy and Governance AZ-DPA-2 Article 2 - Basic Concepts CPG-6.B Supply Chain Incident Reporting COBIT-BAI02 Managed requirements definition 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 Sapin2-Pillar1-Code-of-Conduct Pillar 1 - Anti-Corruption Code of Conduct ICP-1 Objectives, Powers and Responsibilities of the Supervisor 62351-2 Glossary of terms ISO-14064-1-5.1 Organizational boundaries ISO-26262-3-5 Item definition ISO28001-PI-01 Personnel Security Screening ISO27003-4.3 Determining the scope of the information security management system 27007-5.2 Audit Programme Objectives 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 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) IM8-RES.2 Disaster Recovery ISMSP-SYS-04 Vulnerability Management 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 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 USMCADIGITAL-1 Cross-Border Data Flows and Localisation 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 .
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