ISO INTERNATIONAL STANDARD 15378 Fourth edition 2017-09 Primary packaging materials for medicinal products Particular requirements for the application of IS0 9001:2015, with reference to good manufacturing practice (GMP) Articlesd'emballageprimairepourmedicamentsExigences particulieres pour I'application de I'is0 9001:2015 prenant en considération les bonnes pratiques de fabrication (BPF) Reference number IS0 15378:2017(E) os1 @IS0 2017 IS0 15378:2017(E) Contents Page Foreword V Introduction.. 1 Scope. 1 2 Normative references. .1 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 9 3.9 Terms related to characteristic. 10 3.10 Terms related to determination. 10 3.11 Terms relating to risk management. 11 4 Context of the organization .. .12 4.1 Understanding the organization and its context. 12 4.2 Understanding the needs and expectations of interested parties. 12 4.3 Determining the scope of the quality management system.. 13 4.4 Quality management system and its processes... 13 5 Leadership 5.1 Leadership and commitment. .14 5.1.1 General.... 5.1,2 Customer focus. .15 5.1.3 Customer audits. 15 5.2 Policy.. 15 5.3 Organizational roles, responsibilities and authorities. 16 6 Planning. .17 6.1 Actions to address risks and opportunitie 17 6.2 Quality objectives and planning to achieve them. 18 6.3 Planning of changes. .19 7 Support. .19 7.1 Resources .19 7.1.1 General 19 7.1.2 People. 19 7.1.3 Infrastructure 20 7.1.4 Environment for the operation of processes. 21 7.1.5 Monitoring and measuring resources . 23 7.1.6 Organizational knowledge. 24 7.2 Competence. 24 7.2.1 General. 24 7.2.2 GMP-training. 24 7.3 Awareness. 7.4 Communication 25 7.5 Documented information. 26 7.5.1 General. 26 7.5.2 Creating and updating.. 26 7.5.3 Control of documented information 27 7.5.4 Administration of IT systems and data. 28 8 Operation. 29 @ IS0 2017 - All rights reserved ili IS0 15378:2017(E) 8.1 Operational planning and control . 29 8.2 Requirements for products and services.. .30 8.2.1 Customer communication.. .30 8.2.2 Determining the requirements for products and services. 8.2.3 Review of the requirements forproducts and services ... 31 8.2.4 Changes to requirements for products and services. 32 8.3 Design and development of products and services. ..32 8.3.1 General. .32 8.3,2 Design and development planning. .32 8.3.3 Design and development inputs... 33 8.3.4 Design and development controls. 33 8.3,5 Design and development outputs.. .34 8.3.6 Design and development changes... 8.4 Control of externally provided processes, products and services 35 8.4.1 8.4.2 Type and extent of control. ..36 8.4.3 Informationforexternalproviders. .37 8.5 Production and service provision. .38 8.5.1 Control of production and service provision. .38 8.5,2 Identification and traceability.. 41 8.5.3 Property belonging to customers or external providers. .42 8.5.4 Preservation... 42 8.5.5 Post-delivery activities. 43 8.5.6 Control of changes.. ..43 8.6 Release of products and services. 44 8.7 Control of nonconforming outputs.. .44 9 Performance evaluation s 9.1 Monitoring, measurement, analysis and evaluation. 9.1.1 General..... ..45 9.1.2 Customer satisfaction. 45 9.1.3 Analysis and evaluation. .46 9.2 Internal audit. .*.48 9.3 Management review. .48 9.3.1 General. ..48 9.3.2 Management review inputs.. .49 9.3.3 Management review outputs. .49 10 Improvement. 10.1 General. .50 10.2 Nonconformity and corrective action. .50 10.3 Continual improvement .51 Annex A (informative) Clarification of new structure, terminology and concepts.. 52 Annex B (informative) Other International Standards on quality management and quality management systems developed by IS0/TC 176 ..56 Annex C (normative) GMP requirements for printed prima