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1、【精品文档】如有侵权，请联系网站删除，仅供学习与交流0123 ISO15378 药品原始包装材料-良好生产规范.精品文档.4 Introduction0.1 GeneralThis 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 r
2、ealization 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 should ens
3、ure 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 are the f
4、ollowing. Those clauses or subclasses that are quoted directly and unchanged from ISO 9001:2000are in coxed 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 referred to
5、in brackets.ISO 9001:2000, Quality management systems Requirements0.1 GeneralThe 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 varying needs, particular objective
6、s, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified
7、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 parties, including certification bodies, to assess the o
8、rganizations ability to meet customer, regulatory 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 Standard is to def
9、ine 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.0.2 Process approachISO 9001:2000, Quality management systems
10、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 satisfaction by meeting customer requirements.For an organization to function effe
11、ctively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.The application of a system
12、 of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processe
13、s 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 p
14、rocess performance and effectiveness, andd) continual improvement of processes based on objective measurement.The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significa
15、nt 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 met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Stand
16、ard, 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 r
17、equirements and the organizations policies.Do: implement the processes.Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.Act: take actions to continually improve process performance.Figure 1 Model of a process-based
18、quality management system0.3 Relationship with ISO 9004ISO 9001:2000, Quality management systems Requirements0.3 Relationship with ISO 9004The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complem
19、ent each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.ISO 9001 specifies requirements for a quality management system that can be used for internal app
20、lication by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for t
21、he continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it
22、 is not intended for certification or for contractual purposes.0.4 Compatibility with other management systemsThis International Standard incorporates the requirements of ISO9001:2000 and additionally particular requirements for primary packaging materials, which are derived and adapted, as appropri
23、ate, from Good manufacturing Practice for the production and control of medicinal products.ISO 9001:2000, Quality management systems Requirements0.4 Compatibility with other management systemsThis International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of th
24、e two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, thi
25、s International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the
26、 requirements of this International Standard.Primary packaging materials for medicinal products Particular requirements for the application for ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)5 Scope1.1 GeneralThis International Standard specifies requirements for a quality managem
27、ent system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.In this Internationa
28、l Standard the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.ISO 9001:2000, Quality management systems Requirements1.1 GeneralThis International Standard spe
29、cifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, includ
30、ing processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.1.2 ApplicationThis International Stan
31、dard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.ISO 9001:2000, Quality management systems Requirements1.2 ApplicationAll requirements of this International Standard are gene
32、ric and are intended to be applicable to all organizations, regardless of type, size and product provided.Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, cl
33、aims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.2 No
34、rmative referenceThe following referenced documents are indispensable for the application of this 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
35、 systems Requirements2 Normative referenceThe following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However
36、, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC m
37、aintain registers of currently valid International Standards.ISO 9000:2000, Quality management systems Fundamentals and vocabulary.ISO 9001:2000, Quality management systems RequirementsISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanlinessISO146
38、44-2:2000, Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1ISO14644-3, Cleanrooms and associated controlled environments Part 3: Test methodsISO14644-4:2001, Cleanrooms and associated controlled environ
39、ments Part 4: Design, construction and start-upISO14644-5, Cleanrooms and associated controlled environments Part 5: Operations3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.ISO 9001:2000, Quality management systems Requi
40、rements3 Terms and definitionsFor the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:The term “organization” repl
41、aces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.NOTE
42、1 In addition, the terminology subcontractor (see 3.61) and outsourcing (see 3.34) is used for this International StandardNOTE2 The term “subcontractor” is still predominantly used in the pharmaceutical packaging industry over that of “supplier”.Additional terms and definitions used in this Internat
43、ional Standard are specific to Good Manufacturing Practices applicable to the manufacture of primary packaging materials for medicinal products.air-lockenclosed space to control air-flowNote The space typically has at least two interlocked doors between two or more rooms, used by either people or fo
44、r goods, to control for different conditions, e.g. cleanliness, air-flow upon entering.Approvedconfirmed conformity statusNote Conformity can be confirmed for any stage of the process (starting materials, process aids, packaging material or finished product).3.1 assemblyfitting together of primary p
45、ackaging materials (3.35.1) and/or componentsNote Examples may include pipette assemblies for filling, prepared components of injection systems positioning of needle shields on prefillable syringes.3.2 automated inspectionconformity evaluation performed by inspection equipment without manual interve
46、ntionNote The inspection equipment can include optoelectronics (cameras), laser systems, ultrasonics and their associated data processing functions or others.3.3 batchlotdefined quantity of primary packaging material (3.35.1) manufactured in one process or series of processes intended to have unifor
47、m characteristics with consistent, homogeneous qualityNote1 To meet production requirements or customer needs, a batch can be divided up into a number of sub-batches that are later combined to from a single, consistent batch.Note2 In the case of continuous production, the batch is a fraction of the
48、production defined either as a fixed quantity or as the amount produced in a fixed time interval.3.4 batch documentbatch recorddocuments 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). 3.5 batch numberlot numberunique identifier to identify a batch or lot (3.5).NOTE A batch number 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 b