1、BSI Standards PublicationBS EN ISO 15378:2015Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)BS EN ISO 15378:2015 BRITISH STANDARDNational forewordThis British Standard is the UK imple
2、mentation of EN ISO15378:2015. It supersedes BS EN ISO 15378:2011 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not pur
3、port to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 83779 1ICS 03.120.10; 11.040.01Compliance with a British Standard cannot confer immunity fromlegal
4、 obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15378 November 2015 ICS 11.040.01;
5、 03.120.10 Supersedes EN ISO 15378:2011English Version Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) Articles de conditionnement primaire pour mdicaments - Exigen
6、ces particulires pour lapplication de lISO 9001:2008 prenant en considration les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2015) Primrpackmittel fr Arzneimittel - Besondere Anforderungen fr die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2015) This E
7、uropean Standard was approved by CEN on 3 October 2015. 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 national standard without any alteration. Up-to-date lists and bibliographical references
8、 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 version in any other language made by translation under the responsibility of a CEN memb
9、er 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fra
10、nce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KO
11、MITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15378:2015 EBS EN ISO 15378:2015EN ISO 15378:2015 (E) 3 European foreword This document (EN
12、ISO 15378:2015) 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 of a national standard, either by publication of an identical text or by endor
13、sement, at the latest by May 2016, and conflicting national standards shall be withdrawn at the latest by May 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying a
14、ny or all such patent rights. This document supersedes EN ISO 15378:2011. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Den
15、mark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement n
16、otice The text of ISO 15378:2015 has been approved by CEN as EN ISO 15378:2015 without any modification. BS EN ISO 15378:2015ISO 15378:2015(E)Foreword vIntroduction vi1 Scope . 11.1 General . 11.2 Application 22 Normative references 23 Terms and definitions . 23.1 Terms relating to quality 33.2 Term
17、s relating to management 33.3 Terms relating to organization 33.4 Terms relating to processes and product . 43.5 Terms relating to characteristics . 73.6 Terms relating to conformity 83.7 Terms relating to documentation. 93.8 Terms relating to examination . 93.9 Terms relating to risk management .11
18、4 Quality management system .124.1 General requirements 124.1.1 Risk management 134.2 Documentation requirements. 144.2.1 General. 144.2.2 Quality manual .154.2.3 Control of documents .154.2.4 Control of records 165 Management responsibility .175.1 Management commitment . 175.2 Customer focus 175.2.
19、1 Customer audits 175.3 Quality policy . 175.4 Planning . 185.4.1 Quality objectives .185.4.2 Quality management system planning 185.5 Responsibility, authority and communication 185.5.1 Responsibility and authority 185.5.2 Management representative . 195.5.3 Internal communication . 195.6 Managemen
20、t review 195.6.1 General. 195.6.2 Review input .205.6.3 Review output .206 Resource management 206.1 Provision of resources . 206.2 Human resources . 216.2.1 General. 216.2.2 Competence, training and awareness .216.3 Infrastructure 226.4 Work environment 226.4.1 Work environment requirements .226.4.
21、2 Classification of clean zones/cleanrooms 236.4.3 Risk control of contamination .236.4.4 Pest control 236.4.5 Materials and utilities (ancillary services) 23 ISO 2015 All rights reserved iiiContents PageBS EN ISO 15378:2015ISO 15378:2015(E)6.5 Maintenance and cleaning activities247 Product realizat
22、ion .257.1 Planning of product realization . 257.2 Customer-related processes . 257.2.1 Determination of requirements related to the product 257.2.2 Review of requirements related to the product .267.2.3 Customer communication . 267.3 Design and development . 277.3.1 Design and development planning
23、277.3.2 Design and development inputs 287.3.3 Design and development outputs 287.3.4 Design and development review . 287.3.5 Design and development verification .297.3.6 Design and development validation .297.3.7 Control of design and development changes 297.4 Purchasing . 307.4.1 Purchasing process
24、 .307.4.2 Purchasing information 317.4.3 Verification of purchased product .317.5 Production and service provision 327.5.1 Control of production and service provision 327.5.2 Validation of processes for production and service provision 347.5.3 Identification and traceability . 357.5.4 Customer prope
25、rty 367.5.5 Preservation of product 367.6 Control of monitoring and measuring equipment 378 Measurement, analysis and improvement .378.1 General 378.2 Monitoring and measurement 388.2.1 Customer satisfaction .388.2.2 Internal audit .388.2.3 Monitoring and measurement of processes 398.2.4 Monitoring
26、and measurement of product .398.3 Control of nonconforming product 408.4 Analysis of data 418.5 Improvement . 418.5.1 Continual improvement 418.5.2 Corrective action .428.5.3 Preventive action 42Annex A (normative) GMP requirements for printed primary packaging materials .43Annex B (informative) Gui
27、dance on verification, qualification and validation requirements for primary packaging materials .47Annex C (informative) Relationship between clauses of this International Standard and the high level structure .59Bibliography .62iv ISO 2015 All rights reservedBS EN ISO 15378:2015ISO 15378:2015(E)Fo
28、rewordISO (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 subject for which a tech
29、nical 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 (IEC) on all matters of
30、 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 noted. This document
31、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 identifying any or all such p
32、atent 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 of users and does n
33、ot constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informatio
34、nThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 15378:2011), which has been technically revised to include requirements on
35、 risk management and replace the former guidance on risk management by references to relevant standards and guidelines, extensively revise the guidance on verification, qualification and validation requirements for primary packaging materials, and amend the requirements on infrastructure, work envir
36、onment, maintenance and cleaning activities, customer communication, control of production and service provision and batch release. ISO 2015 All rights reserved vBS EN ISO 15378:2015ISO 15378:2015(E)IntroductionGeneralThis International Standard identifies Good Manufacturing Practice (GMP) principle
37、s 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 safety of a patient using the
38、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 International Standard is an application standard for primary packaging mate
39、rials, which contains the normative text of ISO 9001:2008.The following are the conventions for the layout of this International Standard. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001:2008 are in boxed text. Texts in italics contain additional relevant GMP informa
40、tion regarding primary packaging materials.GMP terms and definitions are included in Clause 3. If listed, the source is referred to in brackets.ISO 9001:2008, Quality management systems Requirements0.1 GeneralThe adoption of a quality management system should be a strategic decision of an organizati
41、on. The design and implementation of an organizations quality management system is influenced bya) its organizational environment, changes in that environment, and the risks associated with that environment,b) its varying needs,c) its particular objectives,d) the products it provides,e) the processe
42、s it employs,f) its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality man-agement systems or uniformity of documentation.The quality management system requirements specified in this International Standard are comple-
43、mentary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, st
44、atutory and regulatory requirements applicable to the product, and the organizations own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.A key objective of this International Stand
45、ard is to define harmonized primary packaging material requirements. It includes some particular requirements for primary packaging materials, which are derived from Good Manufacturing Practices for the production, control, etc. of medicinal products.vi ISO 2015 All rights reservedBS EN ISO 15378:20
46、15ISO 15378:2015(E)Process approachISO 9001:2008, Quality management systems Requirements0.2 Process approachThis International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satis
47、faction by meeting customer requirements.For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered a process. Of
48、ten the output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach
49、”.An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.When used within a quality management system, such an approach emphasizes the importance ofa) understanding and meeting requirements,b) the need to consider processes in terms of added value,c) obtaining results of process performance and effectiveness, andd) continual improvement of processes based on objective measurement.The
