1、Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)BS EN ISO 15378:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewor
2、dThis British Standard is the UK implementation of EN ISO 15378:2017. It is identical to ISO 15378:2017. It supersedes BS EN ISO 15378:2015, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this commit
3、tee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 95555 6ICS 03.100.7
4、0; 11.040.01; 03.120.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH S
5、TANDARDBS EN ISO 15378:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15378October 2017ICS 03.100.70; 11.040.01 Supersedes EN ISO 15378:2015EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-
6、1000 Brussels 2017 CEN Ref. No. EN ISO 15378:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersPrimary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturi
7、ng practice (GMP) (ISO 15378:2017)Articles demballage primaire pour mdicaments - Exigences particulires pour lapplication de lISO 9001:2015 prenant en considration les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2017)Primrpackmittel fr Arzneimittel - Besondere Anforderungen fr die Anwendung von
8、 ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017)This European Standard was approved by CEN on 13 October 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nati
9、onal standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A vers
10、ion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Cz
11、ech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United K
12、ingdom.English VersionEN ISO 15378:2017 (E)European forewordThis document (EN ISO 15378:2017) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use”.This European Standard shall be given the status o
13、f a national standard, either by publication of an identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be withdrawn at the latest by April 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of p
14、atent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 15378:2015.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: A
15、ustria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, S
16、pain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 15378:2017 has been approved by CEN as EN ISO 15378:2017 without any modification.2BS EN ISO 15378:2017ISO 15378:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 23.
17、1 Terms related to organization 23.2 Terms related to activity . 33.3 Terms related to system 43.4 Terms related to requirement 53.5 Terms related to process 63.6 Terms related to results 73.7 Terms related to data, information and document 83.8 Terms related to action 93.9 Terms related to characte
18、ristic 103.10 Terms related to determination 103.11 Terms relating to risk management . 114 Context of the organization 124.1 Understanding the organization and its context 124.2 Understanding the needs and expectations of interested parties .124.3 Determining the scope of the quality management sys
19、tem 134.4 Quality management system and its processes . 135 Leadership .145.1 Leadership and commitment 145.1.1 General. 145.1.2 Customer focus .155.1.3 Customer audits.155.2 Policy 155.3 Organizational roles, responsibilities and authorities.166 Planning 176.1 Actions to address risks and opportuni
20、ties 176.2 Quality objectives and planning to achieve them .186.3 Planning of changes . 197 Support 197.1 Resources 197.1.1 General. 197.1.2 People . 197.1.3 Infrastructure 207.1.4 Environment for the operation of processes 217.1.5 Monitoring and measuring resources 237.1.6 Organizational knowledge
21、247.2 Competence 247.2.1 General. 247.2.2 GMP-training 247.3 Awareness 257.4 Communication . 257.5 Documented information 267.5.1 General. 267.5.2 Creating and updating 267.5.3 Control of documented information 277.5.4 Administration of IT systems and data288 Operation 29 ISO 2017 All rights reserve
22、d iiiContents PageBS EN ISO 15378:2017ISO 15378:2017(E)8.1 Operational planning and control . 298.2 Requirements for products and services 308.2.1 Customer communication . 308.2.2 Determining the requirements for products and services .318.2.3 Review of the requirements for products and services 318
23、.2.4 Changes to requirements for products and services .328.3 Design and development of products and services 328.3.1 General. 328.3.2 Design and development planning 328.3.3 Design and development inputs 338.3.4 Design and development controls .338.3.5 Design and development outputs 348.3.6 Design
24、and development changes 348.4 Control of externally provided processes, products and services .358.4.1 General. 358.4.2 Type and extent of control 368.4.3 Information for external providers . 378.5 Production and service provision 388.5.1 Control of production and service provision 388.5.2 Identific
25、ation and traceability . 418.5.3 Property belonging to customers or external providers 428.5.4 Preservation 428.5.5 Post-delivery activities 438.5.6 Control of changes .438.6 Release of products and services . 448.7 Control of nonconforming outputs . 449 Performance evaluation 459.1 Monitoring, meas
26、urement, analysis and evaluation 459.1.1 General. 459.1.2 Customer satisfaction .459.1.3 Analysis and evaluation 469.2 Internal audit . 489.3 Management review 489.3.1 General. 489.3.2 Management review inputs . 499.3.3 Management review outputs . 4910 Improvement .5010.1 General 5010.2 Nonconformit
27、y and corrective action 5010.3 Continual improvement . 51Annex A (informative) Clarification of new structure, terminology and concepts 52Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 .56Annex C (normative) GMP requir
28、ements for printed primary packaging materials 60Annex D (informative) Guidance on verification, qualification and validation requirements for primary packaging materials .64Bibliography .75Alphabetical index of defined terms used in this document 77iv ISO 2017 All rights reservedBS EN ISO 15378:201
29、7ISO 15378:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subj
30、ect for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IE
31、C) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be n
32、oted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifyin
33、g any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience o
34、f users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Ba
35、rriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This fourth edition cancels and replaces the third edition (ISO 15378:2015), whic
36、h has been technically revised. The main technical and editorial changes comprise: the integration of the sector-specific requirements on quality management systems for medicinal products into ISO 9001:2015; the deletion of the requirements on quality manual; the inclusion of all annexes of ISO 9001
37、:2015 into this document; adjustments to the terminology of ISO 9000:2015, where relevant; the inclusion of an alphabetical index of defined terms used in this document. ISO 2017 All rights reserved vBS EN ISO 15378:2017ISO 15378:2017(E)Introduction0.1 General This document identifies Good Manufactu
38、ring Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the s
39、afety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.This document is an application standard for primary
40、 packaging materials, which contains the text of ISO 9001:2015.The conventions for the layout of this document are the following. Those clauses, subclauses or annexes that are quoted directly and unchanged from ISO 9001:2015 and ISO 9000:2015 (under Clause 3) are in boxes. Additional GMP related req
41、uirements and recommendations as well as terms and definitions relevant to the manufacture of primary packaging materials are outside boxes.ISO 9001:2015, Quality management systems Requirements 0.1 General The adoption of a quality management system is a strategic decision for an organization that
42、can help to improve its overall performance and provide a sound basis for sustainable development initiatives.The potential benefits to an organization of implementing a quality management system based on this International Standard are:a) the ability to consistently provide products and services th
43、at meet customer and applicable statutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;c) addressing risks and opportunities associated with its context and objectives;d) the ability to demonstrate conformity to specified quality management system requir
44、ements.This International Standard can be used by internal and external parties.It is not the intent of this International Standard to imply the need for: uniformity in the structure of different quality management systems; alignment of documentation to the clause structure of this International Sta
45、ndard; the use of the specific terminology of this International Standard within the organization.The quality management system requirements specified in this International Standard are complementary to requirements for products and services.This International Standard employs the process approach,
46、which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.vi ISO 2017 All rights reservedBS EN ISO 15378:2017ISO 15378:2017(E)The process approach enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its proces
47、ses are adequately resourced and managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place prev
48、entive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this
49、objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.In this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability.Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.A key objective of this doc
