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BS EN ISO 15378:2017+A1:2024 - TC Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP), 2024
- 30347648_new.pdf [Go to Page]
- National foreword
- European foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions [Go to Page]
- 3.1 Terms related to organization
- 3.2 Terms related to activity
- 3.3 Terms related to system
- 3.4 Terms related to requirement
- 3.5 Terms related to process
- 3.6 Terms related to results
- 3.7 Terms related to data, information and document
- 3.8 Terms related to action
- 3.9 Terms related to characteristic
- 3.10 Terms related to determination
- 3.11 Terms relating to risk management
- 4 Context of the organization [Go to Page]
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
- 5 Leadership [Go to Page]
- 5.1 Leadership and commitment [Go to Page]
- 5.1.1 General
- 5.1.2 Customer focus
- 5.1.3 Customer audits
- 5.2 Policy
- 5.3 Organizational roles, responsibilities and authorities
- 6 Planning [Go to Page]
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
- 7 Support [Go to Page]
- 7.1 Resources [Go to Page]
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the operation of processes
- 7.1.5 Monitoring and measuring resources
- 7.1.6 Organizational knowledge
- 7.2 Competence [Go to Page]
- 7.2.1 General
- 7.2.2 GMP-training
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information [Go to Page]
- 7.5.1 General
- 7.5.2 Creating and updating
- 7.5.3 Control of documented information
- 7.5.4 Administration of IT systems and data
- 8 Operation [Go to Page]
- 8.1 Operational planning and control
- 8.2 Requirements for products and services [Go to Page]
- 8.2.1 Customer communication
- 8.2.2 Determining the requirements for products and services
- 8.2.3 Review of the requirements for products and services
- 8.2.4 Changes to requirements for products and services
- 8.3 Design and development of products and services [Go to Page]
- 8.3.1 General
- 8.3.2 Design and development planning
- 8.3.3 Design and development inputs
- 8.3.4 Design and development controls
- 8.3.5 Design and development outputs
- 8.3.6 Design and development changes
- 8.4 Control of externally provided processes, products and services [Go to Page]
- 8.4.1 General
- 8.4.2 Type and extent of control
- 8.4.3 Information for external providers
- 8.5 Production and service provision [Go to Page]
- 8.5.1 Control of production and service provision
- 8.5.2 Identification and traceability
- 8.5.3 Property belonging to customers or external providers
- 8.5.4 Preservation
- 8.5.5 Post-delivery activities
- 8.5.6 Control of changes
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
- 9 Performance evaluation [Go to Page]
- 9.1 Monitoring, measurement, analysis and evaluation [Go to Page]
- 9.1.1 General
- 9.1.2 Customer satisfaction
- 9.1.3 Analysis and evaluation
- 9.2 Internal audit
- 9.3 Management review [Go to Page]
- 9.3.1 General
- 9.3.2 Management review inputs
- 9.3.3 Management review outputs
- 10 Improvement [Go to Page]
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
- Annex A (informative) Clarification of new structure, terminology and concepts
- Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176
- Annex C (normative) GMP requirements for printed primary packaging materials
- Annex D (informative) Guidance on verification, qualification and validation requirements for primary packaging materials
- Bibliography
- Alphabetical index of defined terms used in this document
- 30487909-WEB.pdf [Go to Page]
- undefined [Go to Page]
- European foreword
- Blank Page
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 3.1 Terms related to organization
- 3.2 Terms related to activity
- 3.3 Terms related to system
- 3.4 Terms related to requirement
- 3.5 Terms related to process
- 3.6 Terms related to results
- 3.7 Terms related to data, information and document
- 3.8 Terms related to action
- 3.9 Terms related to characteristic
- 3.10 Terms related to determination
- 3.11 Terms relating to risk management
- 4 Context of the organization
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
- 5 Leadership
- 5.1 Leadership and commitment
- 5.1.1 General
- 5.1.2 Customer focus
- 5.1.3 Customer audits
- 5.2 Policy
- 5.3 Organizational roles, responsibilities and authorities
- 6 Planning
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
- 7 Support
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the operation of processes
- 7.1.5 Monitoring and measuring resources
- 7.1.6 Organizational knowledge
- 7.2 Competence
- 7.2.1 General
- 7.2.2 GMP-training
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
- 7.5.1 General
- 7.5.2 Creating and updating
- 7.5.3 Control of documented information
- 7.5.4 Administration of IT systems and data
- 8 Operation
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.2.1 Customer communication
- 8.2.2 Determining the requirements for products and services
- 8.2.3 Review of the requirements for products and services
- 8.2.4 Changes to requirements for products and services
- 8.3 Design and development of products and services
- 8.3.1 General
- 8.3.2 Design and development planning
- 8.3.3 Design and development inputs
- 8.3.4 Design and development controls
- 8.3.5 Design and development outputs
- 8.3.6 Design and development changes
- 8.4 Control of externally provided processes, products and services
- 8.4.1 General
- 8.4.2 Type and extent of control
- 8.4.3 Information for external providers
- 8.5 Production and service provision
- 8.5.1 Control of production and service provision
- 8.5.2 Identification and traceability
- 8.5.3 Property belonging to customers or external providers
- 8.5.4 Preservation
- 8.5.5 Post-delivery activities
- 8.5.6 Control of changes
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
- 9 Performance evaluation
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.1.1 General
- 9.1.2 Customer satisfaction
- 9.1.3 Analysis and evaluation
- 9.2 Internal audit
- 9.3 Management review
- 9.3.1 General
- 9.3.2 Management review inputs
- 9.3.3 Management review outputs
- 10 Improvement
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
- Annex A
(informative)
Clarification of new structure, terminology and concepts
- Annex B
(informative)
Other International Standards on quality management and quality management systems developed by ISO/TC 176
- Annex C
(normative)
GMP requirements for printed primary packaging materials
- Annex D
(informative)
Guidance on verification, qualification and validation requirements for primary packaging materials
- Bibliography
- Alphabetical index of defined terms used in this document [Go to Page]
