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1、 Reference number ISO 15378:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 15378 First edition 2006-03-01 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) Matriaux demballage primaire pou
2、r mdicaments Exigences particulires pour lapplication de lISO 9001:2000 prenant en considration les Bonnes Pratiques de Fabrication (BPF) ISO 15378:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but
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7、rg Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved ISO 15378:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv 0 Introduction. v 0.1 General. v 0.2 Process approach vi 0.3 Relationship with ISO 9004 vii 0.4 Compatibility with other management systems. viii 1
8、 Scope . 1 1.1 General. 1 1.2 Application 1 2 Normative references. 2 3 Terms and definitions. 2 4 Quality management system. 11 4.1 General requirements. 11 4.2 Documentation requirements 12 5 Management responsibility . 14 5.1 Management commitment . 14 5.2 Customer focus. 14 5.3 Quality policy 15
9、 5.4 Planning. 15 5.5 Responsibility, authority and communication. 15 5.6 Management review 16 6 Resource management 17 6.1 Provision of resources. 17 6.2 Human resources 18 6.3 Infrastructure. 19 6.4 Work environment 19 6.5 Maintenance activities 20 7 Product realization 20 7.1 Planning of product
10、realization. 20 7.2 Customer-related processes . 21 7.3 Design and development . 22 7.4 Purchasing 25 7.5 Production and service provision. 26 7.6 Control of monitoring and measuring devices 30 8 Measurement, analysis and improvement . 31 8.1 General. 31 8.2 Monitoring and measurement . 31 8.3 Contr
11、ol of nonconforming product. 33 8.4 Analysis of data 34 8.5 Improvement . 34 Annex A (normative) GMP requirements for printed primary packaging materials 36 Annex B (informative) Guidance on verification and validation requirements for primary packaging materials . 40 Annex C (informative) Guidance
12、on risk management for primary packaging materials. 49 Bibliography. 56 Index 58 ISO 15378:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inter
13、national Standards is normally carried out through ISO technical committees. Each member body interested in a subject 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 wit
14、h ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technica
15、l committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated 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
16、 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 patent rights. ISO 15378 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pha
17、rmaceutical use. ISO 15378:2006(E) ISO 2006 All rights reserved v 0 Introduction 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
18、. 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 medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials sho
19、uld ensure that these materials meet the needs and requirements of the pharmaceutical industry. This International Standard is an application standard for primary packaging materials which contains the requirements text of ISO 9001:2000. The conventions for the layout of this International Standard
20、are the following. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001:2000 are in boxed text. Texts in italics contain additionally relevant GMP requirements for primary packaging materials. GMP terms and definitions are included in Clause 3. If listed, the source is re
21、ferred to in brackets. ISO 9001:2000, Quality management systems Requirements 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 Manufact
22、uring Practices for the production, control, etc. of medicinal products. -,-,- ISO 15378:2006(E) vi ISO 2006 All rights reserved 0.2 Process approach ISO 9001:2000, Quality management systems Requirements ISO 15378:2006(E) ISO 2006 All rights reserved vii 0.3 Relationship with ISO 9004 ISO 9001:2000
23、, Quality management systems Requirements ISO 15378:2006(E) viii ISO 2006 All rights reserved 0.4 Compatibility with other management systems This International Standard incorporates the requirements of ISO 9001:2000 and additionally particular requirements for primary packaging materials, which are
24、 derived and adapted, as appropriate, from Good Manufacturing Practices for the production and control of medicinal products. ISO 9001:2000, Quality management systems Requirements -,-,- INTERNATIONAL STANDARD ISO 15378:2006(E) ISO 2006 All rights reserved 1 Primary packaging materials for medicinal
25、 products Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary
26、 packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. In this International Standard the term “if appropriate” is used several times. When a requirement is q
27、ualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise. ISO 9001:2000, Quality management systems Requirements 1.2 Application This International Standard is an application standard for the design, manufacture and supply of primary pa
28、ckaging materials for medicinal products. It is also applicable for certification purposes. ISO 9001:2000, Quality management systems Requirements ISO 15378:2006(E) 2 ISO 2006 All rights reserved 2 Normative references The following referenced documents are indispensable for the application of this
29、document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9001:2000, Quality management systems Requirements ISO 9001:2000, Quality management systems Requirements ISO 14644-1:1999, Cl
30、eanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 14644-2:2000, Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 ISO 14644-3, Cleanrooms and associated contro
31、lled environments Part 3: Test methods ISO 14644-4:2001, Cleanrooms and associated controlled environments Part 4: Design, construction and start-up ISO 14644-5, Cleanrooms and associated controlled environments Part 5: Operations 3 Terms and definitions For the purposes of this document, the terms
32、and definitions given in ISO 9000 and the following apply. ISO 9001:2000, Quality management systems Requirements NOTE 1 In addition, the terminology subcontractor (see 3.61) and outsourcing (see 3.34) is used for this International Standard. NOTE 2 The term “subcontractor” is still predominantly us
33、ed in the pharmaceutical packaging industry over that of “supplier”. ISO 15378:2006(E) ISO 2006 All rights reserved 3 Additional terms and definitions used in this International Standard are specific to Good Manufacturing Practices applicable to the manufacture of primary packaging materials for med
34、icinal products. 3.1 air-lock enclosed space to control air-flow NOTE The space typically has at least two interlocked doors between two or more rooms, used by either people or for goods, to control for different conditions, e.g. cleanliness, air-flow upon entering. 3.2 approved confirmed conformity
35、 status NOTE Conformity can be confirmed for any stage of the process (starting materials, process aids, packaging material or finished product). 3.3 assembly fitting together of primary packaging materials (3.35.1) and/or components NOTE Examples may include pipette assemblies for filling, prepared
36、 components of injection systems or positioning of needle shields on prefillable syringes. 3.4 automated inspection conformity evaluation performed by inspection equipment without manual intervention NOTE The inspection equipment can include optoelectronics (cameras), laser systems, ultrasonics and
37、their associated data processing functions or others. 3.5 batch lot defined quantity of primary packaging material (3.35.1) manufactured in one process or series of processes intended to have uniform characteristics with consistent, homogeneous quality NOTE 1 To meet production requirements or custo
38、mer needs, a batch can be divided up into a number of sub-batches that are later combined to form a single, consistent batch. NOTE 2 In the case of continuous production, the batch is a fraction of the production defined either as a fixed quantity or as the amount produced in a fixed time interval.
39、3.6 batch document batch record documents and records that provide a history of the batch (3.5), including information relating to its production and control, and which facilitate its traceability (3.63) 3.7 batch number lot number unique identifier to identify a batch or lot (3.5) NOTE A batch numb
40、er can be a combination of numbers, letters and/or symbols which identifies a batch (or lot) and from which the production and distribution history can be determined. ISO 15378:2006(E) 4 ISO 2006 All rights reserved 3.8 batch release decision to release the batch (3.5) for sale or supply, following
41、a formal review of the batch document (3.6) performed by the quality unit (3.41) or a person authorized by the quality unit(s) 3.9 calibration process of checking or adjusting (by comparison with a reference standard) the accuracy of a measuring instrument NOTE Calibration can also be described as t
42、he set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or values represented by a material measure, and the corresponding known values of a reference standard. 3.10 change control documented control of changes NOTE Change
43、s may include, e.g. changes in raw materials, specifications, facilities, equipment, production processes and test methods. 3.11 cleanroom room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and
44、retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary ISO 14644-1:1999, 2.1.1 3.12 clean zone dedicated space in which the concentration of airborne particles is controlled, and which is constructed and u
45、sed in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary ISO 14644-1:1999, 2.1.2 NOTE This zone may be open or enclosed and may or may not be loc
46、ated within a clean room. 3.13 contamination introduction of any unwanted material into the primary packaging material (3.35.1) NOTE 1 A finished product can be contaminated by physical (particulate), chemical or biological (bio- and endotoxin burden) action. NOTE 2 Contamination can occur during pr
47、oduction, packaging, storage and/or distribution from contaminated air systems, personnel, sampling equipment, materials, premises or containers. 3.14 controlled area controlled environment area or environment constructed and operated to control the possible introduction of potential contaminants NO
48、TE 1 The area is typically constructed and operated to control the introduction of potential contamination and the consequences of accidental release of living organisms. NOTE 2 An appropriate pressure differential allows for the efficient removal of airborne contaminants, potential contamination an
49、d the consequences of accidental release. ISO 15378:2006(E) ISO 2006 All rights reserved 5 3.15 cross-contamination mix-up contamination (3.13) of a material or of a product with another material or product EC Guide to GMP NOTE Cross-contamination may also be referred to as admixture. 3.16 customer complaint customer information about deficiencies and/or nonconformities NOTE 1 The information may