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1、现代资源公司 - 1 -治疗用产品委员会澳大利亚医用产品良好生产规范2002 年 8 月 16 日Chapter 1QUALITY MANAGEMENT 质量管理PRINCIPLE 原理The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do no
2、t place patients at risk due to inadequate safety, quality or efficacy. 制造权所有者必须生产医用产品以保证符合预期用途，与市场认可保持一致，并且不会由于不良的安全，质量及效果给患者带来风险。The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments
3、and at all levels within the company, by the companys suppliers and by the distributors.这些质量目标的达到不仅是高级管理人员的职责，而且需要公司很多不同的部门，各个层次的职员，以及供应商，销售商来参与并做出承诺。To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating
4、 Good Manufacturing Practice and thus Quality Control.确保质量目标的达到必须有一个全面的策划及正确执行的质量保证体系，它由生产管理规范及质量控制结合而成。It should be fully documented and its effectiveness monitored.它应该充分的文件化并且监测它的效果。All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and
5、 sufficient premises, equipment and facilities. 质量保证体系的各个部分应该具备充分的资源，包括适当的人员，适宜的和充分的基础设施，设备和工具。There are additional legal responsibilities for the holder of the manufacturing authorization and for the authorised person(s).生产权所有人以及授权人具有附加的法律责任。1.1. The basic concepts of Quality Assurance, Good Manufa
6、cturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.质量保证，生产规范，质量控制的基本理论是相互联系的，这里的描述是要强调它们对医用产品的生产的控制的联系及重要性。现代资源公司 - 2 -QUALITY ASSURANCE 质量保证1.2
7、. Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. 1.2质量保证是一个具有广泛含义的概念，覆盖所有单一的或共同的影响产品质量的事宜It is the sum total of the organised arrangements made with the object of ensuring that medicinal products are of the
8、quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Code.它是组织根据目标制定的措施的总和，以确保医用产品的质量符合预期使用的要求，质量保证因此结合了生产质量管理规范和其它不在本标准范围内的影响因素。The system of Quality Assurance appropriate for the manufacture of me
9、dicinal products should ensure that:适用于医用产品的质量保证体系应该确保：i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice;医用产品的设计和开发应该考虑生产质量管理规范及实验室管理规范。ii. production and control operations are clearly specifi
10、ed and Good Manufacturing Practice adopted;生产和控制的操作规程清楚，符合生产管理规范要求。iii. managerial responsibilities are clearly specified;管理职责说明清楚。iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;生产，供应和正确的原料和包装材料的使用要制定措施。v. all necessary controls on inter
11、mediate products, and any other inprocess controls and validations are carried out;所有必需的对中间产品，过程的控制及验证被执行。vi. the finished product is correctly processed and checked, according to the defined procedures;通过规定的程序，正确的处理，检查最终产品。vii. medicinal products are not sold or supplied before an authorised person
12、 has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal products;现代资源公司 - 3 -在授权人证实，每批产品都在规定的要求下生产出来，包括市场许可和其它医用产品的相关生产、控制、销售法规
13、等，医用产品不能销售或供应。viii. Satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;存在符合要求的措施确保质量在保存期内保持不变，尽可能的直至医用产品储存，销售及随后搬运过程。ix. there is a procedure for self-in
14、spection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.有自我检查和/或质量审核的程序，周期性的评价质量保证体系的有效性与效率。GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP)1.3. Good Manufacturing Practice is that part of Quality Assurance which ensures tha
15、t products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification.生产管理规范是质量保证部的一部分，它将保证产品生产，控件制标准的一致性，适应于产品的使用目的和市场授权及产品说明的需要。Good Manufacturing Practice is concerned with both produc
16、tion and quality control. The basic requirements of GMP are that:生产管理规范与产品生产和质量控制有关，GMP的基本要求是：i. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications
