EUGMPChapter6质量控制.docVIP

欧盟GMP第6章 EU GMP Chapter 6 Quality Control Chapter 6 Quality Control 第6章 质量控制 Table of Contents Principle General Good Quality Control Laboratory Practice Documentation Sampling Testing On-going Stability Programme 表格内容 原则 通则 GCP 文件 取样 检测 持续稳定性考察 Principle Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from Production is considered fundamental to the satisfactory operation of Quality Control. (see also Chapter 1). 原则 质量 控制涉及取样、质量标准和检验，以及组织机构、文件系统和发放程序，以确保进行了必要的相关检验，在判定质量合格之前，物料不得放行使用，或产品不得放行销售或供应。质量控制不仅限于实验室操作，还必须参与所有与产品质量有关的决定。质量控制独立于生产是获得满意质量控制的基础（参见第一章 质量管理）。 General 6.1 Each holder of a manufacturing authorisation should have a Quality Control Department. This department should be independent from other departments, and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his disposal. Adequate resources must be available to ensure that all the Quality Control arrangements are effectively and reliably carried out. 6.2 The principal duties of the head of Quality Control are summarised in Chapter 2. The Quality Control Department as a whole will also have other duties, such as to establish, validate and implement all quality control procedures, keep the reference samples of materials and products, ensure the correct labelling of containers of materials and products, ensure the monitoring of the stability of the products, participate in the investigation of complaints related to the quality of the product, etc. All thes