1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15378:2011Primary packaging materialsfor medicinal products -Particular requirements for the applicationof ISO 9001:2008, with reference toGood Manufacturing Practice (
2、GMP) (ISO15378:2011)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO
3、15378:2011. It supersedes BS EN ISO 15378:2007 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained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 purport to include all
4、 the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68838 6ICS 03.120.10; 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Poli
5、cy and Strategy Committee on 30 November 2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPEN
6、NE EUROPISCHE NORM EN ISO 15378 November 2011 ICS 03.120.10; 11.040.01 Supersedes EN ISO 15378:2007English Version Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011) A
7、rticles de conditionnement primaire pour mdicaments - Exigences particulires pour lapplication de lISO 9001:2008 prenant en considration les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2011) Primrpackmittel fr Arzneimittel - Besondere Anforderungen fr die Anwendung von ISO 9001:2008 entsprechen
8、d der Guten Herstellungspraxis (GMP) (ISO 15378:2011) This European Standard was approved by CEN on 3 November 2011. 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 an
9、y 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 version in any other langua
10、ge 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, Czech Republic, Denmark,
11、 Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION
12、 EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15378:2011: ECopyright European Committee for Standardization Provided by IHS under licen
13、se with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011EN ISO 15378:2011 (E) 3 Foreword This document (EN ISO 15378:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment
14、 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 endorsement, at the latest by May 2012, and conflicting national standards shall be withdrawn at the latest by May 2012. Attention is drawn
15、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 any or all such patent rights. This document supersedes EN ISO 15378:2007. According to the CEN/CENELEC Internal Regulations, the nation
16、al standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, N
17、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15378:2011 has been approved by CEN as a EN ISO 15378:2011 without any modification. Copyright European Committee for Standardization Provided by IHS under lice
18、nse with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword . v Introduction vi 0.1 General vi 0.2 Process approach viii 0.3 Relationship with ISO 9004 x 0.4 Compatibility
19、with other management systems . x 1 Scope 1 1.1 General . 1 1.2 Application . 1 2 Normative references 2 3 Terms and definitions . 2 4 Quality management system 12 4.1 General requirements . 12 4.2 Documentation requirements 13 5 Management responsibility 16 5.1 Management commitment 16 5.2 Customer
20、 focus . 16 5.3 Quality policy . 17 5.4 Planning . 17 5.5 Responsibility, authority and communication . 18 5.6 Management review 19 6 Resource management . 20 6.1 Provision of resources 20 6.2 Human resources 20 6.3 Infrastructure . 22 6.4 Work environment . 22 6.5 Maintenance activities 23 7 Produc
21、t realization 24 7.1 Planning of product realization 24 7.2 Customer-related processes 25 7.3 Design and development 26 7.4 Purchasing . 29 7.5 Production and service provision . 31 7.6 Control of monitoring and measuring equipment . 36 8 Measurement, analysis and improvement 37 8.1 General . 37 8.2
22、 Monitoring and measurement 37 8.3 Control of nonconforming product . 40 8.4 Analysis of data . 41 8.5 Improvement 41 Annex A (normative) GMP requirements for printed primary packaging materials 43 Annex B (informative) Guidance on verification and validation requirements for primary packaging mater
23、ials 47 Annex C (informative) Guidance on risk management for primary packaging materials . 56 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(
24、E) iv ISO 2011 All rights reservedBibliography 63 Index .65 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) ISO 2011 All rights reserved vFo
25、reword ISO (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 tec
26、hnical 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 o
27、f electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated
28、to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 fo
29、r identifying any or all such patent rights. ISO 15378 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 15378:2006), which has undergo
30、ne a minor revision to adapt this International Standard to ISO 9001:2008 and update references. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:201
31、1(E) vi ISO 2011 All rights reservedIntroduction 0.1 General This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP princip
32、les in production and control of primary packaging materials within organizations is of great importance for the safety 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 m
33、eet the needs and requirements of the pharmaceutical industry. This International Standard is an application standard for primary packaging materials, which contains the normative text of ISO 9001:2008. The conventions for the layout of this International Standard are the following. Those clauses or
34、 subclauses that are quoted directly and unchanged from ISO 9001:2008 are in boxed text. Texts in italics contain additional relevant GMP information regarding primary packaging materials. GMP terms and definitions are included in Clause 3. If listed, the source is referred to in brackets. Copyright
35、 European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) ISO 2011 All rights reserved viiISO 9001:2008, Quality management systems Requirements 0.1 General Th
36、e adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by a) its organizational environment, changes in that environment, and the risks associated with that environment, b)
37、 its varying needs, c) its particular objectives, d) the products it provides, e) the processes 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 management systems or uniformity of documentation.
38、 The quality management system requirements specified in this International Standard are complementary 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 p
39、arties, including certification bodies, to assess the organizations ability to meet customer, statutory 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
40、during the development of this International Standard. A key objective of this International Standard 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
41、 production, control, etc. of medicinal products. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15378:2011ISO 15378:2011(E) viii ISO 2011 All rights reserved0.2 Proce
42、ss approach ISO 9001:2008, Quality management systems Requirements 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting cu
43、stomer 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. Often the output from
44、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”. An advantage of
45、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 of a) understandi
46、ng and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 il
47、lustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has
48、 met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirement
