9 原料药和中间体的包装和贴签

1、9. 原料药和中间体的包装和贴签9.1 总则9.10 应当有书面程序描述包装和贴签用物 料的接收、鉴别、待验、取样、检查和/或测 试、放行和搬运。9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATESGeneral9.11 包装和贴签用物料应当符合规定的质 量标准。不合格者要拒收，不得用于不适合 于其的操作中。There should be written procedures describing the receipt, identification, quarantine, sampling, examinat

2、ion, and/or testing, release, and handling of packaging and labeling materials.9.12 每次运来的标签和包装材料应当有接 收、检查或测试、以及合格还是拒收的记录。Packaging and labeling materials should conform to established specifications. Those that do not comply with such specifications should be rejected to prevent their use in operati

3、ons for which they are unsuitable.Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or rejected.9.2 包装材料9.20 容器应当能够对中间体和原料药提供 足够的保护，使其在运输和建议的贮存条件 下不会变质或受到污染。Packaging Materials9.21 容器应当清洁，如果中间体或原料药有 要求时，应当进

4、行消毒，以确保适合于其预 期的用途。这些容器应无反应活性、加和性 或吸附性，一面改变中间体或原料药的质量 使其超出质量标准的限度。Containers should provide adequate protection against deterioration or contamination of the intermediate or API that may occur during transportation and recommended storage.9.22 容器被重新使用时，应当按照规定程序 进行清洁，并出去或涂毁以前的所有标签。Containers should be

5、 clean and, where indicated by the nature of the intermediate or API, sanitized to ensure that they are suitable for their intended use. These containers should not be reactive, additive, or absorptive so as to alter the quality of the intermediate or API beyond the specified limits.If containers ar

6、e reused, they should be cleaned in accordance with documented procedures, and all previous labels should be removed or defaced.9.3 标签发放与控制9.30 只有获准人员才能进入标签贮存区。Label Issuance and ControlAccess to the label storage areas should be limited to authorized personnel.9.31 应当建立规程来平衡发出的、使用的和 退回的标签的数量，并评估已贴签

7、的容器数 和发出的标签数之间的偏差值。此种差异应 当加以调查，调查应当由质量保证部门批准。9.32 所有剩余的印有批号或与批有关内容 的标签都应当销毁。收回的标签应当以防止 混淆并提供适当标识的方式加以保留和贮 存。Procedures should be established to reconcile the quantities of labels issued, used, and returned and to evaluate discrepancies found between the number of containers labeled and the number of

8、 labels issued. Such discrepancies should be investigated, and the investigation should be approved by the quality unit(s).9.33 废弃的和过期的标签应当销毁。All excess labels bearing batch numbers or other batch-related printing should be destroyed. Returned labels should be maintained and stored in a manner that

9、prevents mix-ups and provides proper identification.9.34 包装操作中用于印刷标签的印刷设备 应当加以监控，以确保所有印刷内容符合批 生产记录中的内容。Obsolete and out-dated labels should be destroyed.9.35 应当仔细检查发放给某批的打印好的 标签，其标识是否正确，并符合主生产记录 的内容。检查结果应当记录在批生产记录中。Printing devices used to print labels for packaging operations should be controlled t

10、o ensure that all imprinting conforms to the print specified in the batch production record.9.36 批生产记录中应当附一张代表那些所 用标签的印制好的标签。Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record. The results of this examin

11、ation should be documented.A printed label representative of those used should be included in the batch production record.9.4 包装和贴签操作9.40 应当有文件化的规程确保使用正确的 包装材料和标签。Packaging and Labeling Operations9.41 帖签操作应当防止混淆。应当与涉及其 它中间体或原料药的操作有物理的或空间的 隔离。There should be documented procedures designed to ensure t

12、hat correct packaging materials and labels are used.Labeling operations should be designed to prevent mix-ups. There should be physical or spatial separation from operations involving other intermediates or APIs.9.42 用于中间体或原料药容器的标签应当 注明：确保中间体或原料药质量的关键信息 如名称、识别代码、产品批号和储存条件。9.43 如果中间体或原料药要向生产商的物 料管理系统

13、控制范围以外运输，标签上还应 当包括生产商的名称、地址，装量，特殊的 运输要求，和其它特殊的法定要求。对于有 失效期的中间体或原料药，标签和分析报告 单上应当注明失效期。对于有复验期的中间 体或原料药，标签和/或分析报告单上应当注 明复验期。Labels used on containers of intermediates or APIs should indicate the name or identifying code, batch number, and storage conditions when such information is critical to ensure t

14、he quality of intermediate or API.9.44 包装和帖签设施应当在使用前进行检 查，以确定下一次包装操作不需要的所有物 料都已清除。该检查应当记录在批生产记录 设备使用记录或其它文件系统中。If the intermediate or API is intended to be transferred outside the control of the manufacturers material management system, the name and address of the manufacturer, quantity of contents,

15、 special transport conditions, and any special legal requirements should also be included on the label. For intermediates or APIs with an expiry date, the expiry date should be indicated on the label and certificate of analysis. For intermediates or APIs with a retest date, the retest date should be

16、 indicated on the label and/or certificate of analysis.9.45 应当检查已包装和帖签的中间体或原 料药，以确保该批的容器和包装的标签正确 该检查应当作为包装操作的一部分。检查结 果应当记录在批生产或控制记录中。Packaging and labeling facilities should be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed

17、. This examination should be documented in the batch production records, the facility log, or other documentation system.9.46 需向生产商的物料管理系统控制范围以 外运输的中间体或原料药的容器应当用一种 密封形式，以至于一旦密封破损或遗失，收 货者会留意到其内容物有可能被动过。Packaged and labeled intermediates or APIs should be examined to ensure that containers and packages in the batch have the correct label. This examination should be part of the packaging operation. Results of these examinations should be recorded in the batch product