EU-GMP-指南附件8：起始物料和包装材料的取样(中英文)

EU GMP 指南附件8：起始物料和包装材料的取样（中英文）EU GMP 指南附件8：起始物料和包装材料的取样（中英文） Annex 8 附件8SAMPLING OF STARTING AND PACKAGING MATERIALS起始物料和包装材料的取样Principle 原则Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on nonrepresentative samples. Correct sampling is thus an essential part of a system of Quality Assurance.取样是一个重要的操作，取样中，每批仅有小部分被取出。如果对不具有代表性的样品进行检测，则不能得出有效结论。因而正确的取样方法是质量保证体系的必要因素。Note 注Sampling is dealt with in Chapter 6 of the Guide, items 6.11. to 6.14. This annex gives additional guidance on the sampling of starting and packaging materials.取样在指南第6章第6.11至6.14项。本附件针对起始物料和包装物料给出一些额外的指南。Personnel 人员1. Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include:取样人员应接受与正确取样操作相关的初始培训和周期性继续再培训，该培训应包括： sampling plans, 取样计划 written sampling procedures, 书面取样程序 the techniques and equipment for sampling, 取样技术和取样工具 the risks of cross-contamination, 交叉污染风险 the precautions to be taken with regard to unstable and/or sterile substances, 对不稳定和/或无菌物料采取的预防措施 the importance of considering the visual appearance of materials, containers and labels, 考察物料、包材和标签的外观的重要性 the importance of recording any unexpected or unusual circumstances. 记录非预期或异常情况的重要性Starting materials 起始物料2. The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled. 为保证起始物料一个完整批准的鉴别，一般需要对每个包装进行单独取样，独立检测鉴别项。如果建立有经过验证的程序，保证不会有单个包装标签错误情况发生，则允许对部分包装进行取样。3. This validation should take account of at least the following aspects: 本验证需要考虑至少以下方面 the nature and status of the manufacturer and of the supplier and their understanding of the GMP requirements of the Pharmaceutical Industry; 生产商和供应商的具体情况和状态，及其对制药行业GMP要求的理解 the Quality Assurance system of the manufacturer of the starting material; 起始物料生产商的质量保证体系 the manufacturing conditions under which the starting material is produced and controlled; 起始物料的生产受到控制 the nature of the starting material and the medicinal products in which it will be used. 起始物料的属性和使用该起始物料的药品的属性Under such a system, it is possible that a validated procedure exempting identity testing of each incoming container of starting material could be accepted for: 在这种体系下，可能需要一个验证过的程序，以免除对以下起始物料每个进厂包装的鉴别实验 starting materials coming from a single product manufacturer or plant; 起始物料来自于一个仅生产一个产品的生产商或工厂 starting materials coming directly from a manufacturer or in the manufacturers sealed container where there is a history of reliability and regular audits of the manufacturers Quality Assurance system are conducted by the purchaser (the manufacturer of the medicinal product) or by an officially accredited body. 起始物料从生产商处直接送来，或采用生产商的封装容器，有历史数据证明其可靠性，或由采购方（药品生产商）或官方授信主体对生产商的质量保证体系进行常规审计It is improbable that a procedure could be satisfactorily validated for: 对以下情况，则不可能得到一个满意的验证结果 starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited; 由中间商供应的起始物料，如贸易商，该物料的生产商为未知或未经审计 starting materials for use in parenteral products. 用于注射用药生产的起始物料4. The quality of a batch of starting materials may be assessed by taking and testing a representative sample. The samples taken for identity testing could be used for this purpose. The number of samples taken for the preparation of a representative sample should be determined statistically and specified in a sampling plan. The number of individual samples which may be blended to form a composite sample should also be defined, taking into account the nature of the material, knowledge of the supplier and the homogeneity of the composite sample. 通过采取具有代表性的样品进行检测，可以对起始物料的批质量进行评估。鉴别用样品可以用于此目的。用于具有代表性的样品制备的样品数量可以基于统计学数据，并在取样计划中列明。可以用于制备混合样的单个样品数量也应该指定，指定时应考虑物料的特性、对供应商的了解和混合样的均一性。Packaging material 包装材料5. The sampling plan for packaging materials should take account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality Assurance system of the packaging materials manuf