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1、巴西卫生部原料药与中间品 GMP巴西 GMP简介 1、巴西GMP是在Q7A的基础上建立起来的。 Q7A是ICH对原料药生产的指导性文件。ICH（人用药品注册技术要求国际协调会议）由三个地区的代表组成，即欧盟、美国和日本。ICH指导文件是三方公认的国际标准，同时ICH指导文件也日益成为国际上公认的药品注册技术标准。巴西GMP沿用了Q7A的基本原则与框架，大致内容也与其相同，但是，巴西GMP也融入了巴西卫生部对GMP的理解与要求，使之比Q7A更具体、更严格。 2、巴西GMP与中国GMP的比较 中国没有单独针对原料药生产的GMP要求，现行98年修订版 GMP，内容过于简单，版本过于陈旧，两者差距非常
2、大，不可同日而语。 3、巴西GMP基本框架 第一部分：说明GMP是质量管理体系的一种；指明质量管理的基本原则与职责。（第一章至第二章）。 第二部分：对影响产品质量的6要素（5M1E）提出具体要求；对贯穿于所有方面的文件管理提出具体要求。（第三章至第八章）第三部分：对药品生产质量管理的其它几个重要方面提出具体要求。（第九章至第十七章）第一章 一般考虑 1.1 企业资质文件齐全，经常受到药监部门的检查。 （要准备：药监部门的检查记录与报告） 1.2 原料药生产应遵循该法规。 1.3 生产企业应保证产品符合既定质量。 1.4 质量保证、质量控制、GMP是密切相关的三个概念。 1.5 生产企业对产品质
3、量负责。 1.6 要有齐全的证据标明：企业在影响产品质量的各个方面实行了GMP管理。 1.7 生物制品应从工作种子库的维护工序就开始要求GMP管理。2. 质量管理QUALITY MANAGEMENT质量管理决定和执行公司的质量方针,即与质量有关的总体方向和目标,其管理职能由公司的高级管理层正式宣布并授权。quality Management is the aspect of management function that determines and implements the “Quality Policy”, i.e., the overall intentions and direc
4、tions related to quality, formally expressed and authorized by the firm high management.2.1原则Principles2.1.1公司的所有人员对质量负有责任。The quality should be responsibility of all the companys collaborators.2.1.2生产厂家应该建立执行和保持有效的文件化的质量管理体系，并使管理层和所有与生产有关的人员积极参与。Each manufacturer should establish, document, impleme
5、nt and keep an effective system of quality management, which involves active participation of the management and all personnel involved in manufacturing.2.1.3质量管理体系包括公司的组织结构、程序、过程、资源和必要的活动,确保中间品和药物活性成分符合规定的质量和纯度要求。所有相关的活动都应该在文件中规定。The system for quality management should comprise the organizational
6、structure, procedures, processes, resources and necessary activities to assure that the intermediate and the pharmaceutical input are in conformity with the intended specifications of quality and purity. All related activities should be defined and documented.2.1.4必须有一个质量部门负责保证中间品和药物活性成分满足规定的质量标准，并达
7、到使用要求。There must be a quality unit responsible for assuring that intermediates and active pharmaceutical inputs are within the demanded quality standards and that can be used for the proposed purposes.2.1.5质量部门必须独立于生产部门，其职能包括质量保证和质量控制。质量部门可以有一个人或一个小组和部门组成，这取决于公司的大小和结构。There must be an independent Qu
8、ality Unit of production, which comprises responsibilities of both Quality Assurance (QA) and Quality Control (QC), that completes the production responsibilities. The Quality Unit can be represented by a single person or by a group or department, depending on the size and structure of the organizat
9、ion.2.1.6授权放行中间品和药物活性成分的人员应该确定好。The employees authorized to release intermediates and active pharmaceutical inputs should be defined.2.1.7所有与质量相关的活动在完成后应予记录。All activities related to quality should be recorded after their performance.2.1.8所有的偏差应该由文件证明和说明。对关键偏差应进行调查，调查过程和调查结论应该形成文件。All deviations sho
10、uld be documented and explained. Critical deviations should be investigated, and this investigation and its conclusions should be documented2.1.9在质量部门对于物料质量作出满意的结论之前，不得放行和使用这些物料。除非有一套合理的系统允许这样操作。但中间品和药物活性成分没有例外。No material should be released or used before a satisfactory conclusion of the evaluation
11、 by the Quality Unit, except when There must be implemented appropriate systems allowing such a practice, with the exception of intermediates for selling and active pharmaceutical inputs.2.1.10对于发生的质量偏差，必须有通知质量部门的程序，包括采取相关的行动。There must be procedures to notify the Quality Unit whenever quality devia
12、tions occur, including related actions.2.2职责Responsibilities2.2.1介绍Introduction2.2.1.1生产和质量部门的主要岗位应该有全职人员担任。必要时可以代理行使某些职能,但责任不能代理。The main posts of Production and Quality Unit should be occupied by personnel working full time at the firm. There may be necessary to delegate some functions, however, r
13、esponsibility cant be delegated.2.2.1.2根据有关的规定为中间品和药物活性成分的生产和质量控制负责人授予称号，并在教育、经验和培训方面有任职资格。The responsible persons for Production, quality control and quality unit of intermediates and active pharmaceutical inputs should be entitled according to the actual legislation of the respective representativ
14、e class board and qualified with proper education, experience and/or training.2.2.1.3生产和质量部门的负责人应联合进行下列质量活动：The responsible persons for Production and quality unit should exert together certain activities related to quality, such as:a)程序和文件的制定和复核包括对其进行更新。elaboration and review of procedures and docu
15、ments, including its updating;b) 监督和控制生产环境monitoring and control of manufacturing environment;c)卫生 hygiene;d)工艺验证 validation of the process;e)包括GMP原则应用方面的培训training, including application of GMP principles;f)供应商资格确认 supplier qualification;g)合同供应商的批准和监督 approval and monitoring of contract suppliers;h)规定物料和产品的存储条件specifications of storage conditions of materials and products;i)对文件和记录归档document files and records;j)监督是否符合然GMP monitoring of compliance with the GMP;k)检查和调查可能影响中间品和药物活性成分质量的因素。inspection and investigation of factors that may affect the quality of intermediate
