eu-gmp-指南附件8：起始物料和包装材料的取样(中英文).docx

------------- 精选文档 ----------------- 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 8 SAMPLING 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 Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include: 可编辑 ------------- 精选文档 ----------------- 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 可编辑 ------------- 精选文档 ----------------- 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 valid