are performed for the purpose of monitoring and/or adjusting the process.
8.36 生产操作中的正常监控过程和工艺调节过程中出现的超出标准的偏差（OOS），通常情况不需要调查。
8.4 Blending Batches of Intermediates or APIs 8.4 中间体或原料药的混批
8.40 For the purpose of this document, blending is defined as the process of combining materials within the same specification to produce a homogeneous intermediate or API. In-process mixing of fractions from single batches (e.g., collecting several centrifuge loads from a single crystallization batch) or combining fractions from several batches for further processing is considered to be part of the production process and is not considered to be blending. 8.40 根据本文件的目的，混合的定义是为了生产出均匀的中间体或原料药而将同一质量标准的物料混在一起的过程。同一批号几部分（例如，收集一个结晶批号出来的几次离心机装的料）的工艺间的混合，或者混合从几个批号来的部分作进一步加工，看作是生产工艺的一部分，而不是混合。
8.41 Out-of-specification batches should not be blended with other batches for the purpose of meeting specifications. Each batch incorporated into the blend should have been manufactured using an established process and should have been individually tested and found to meet appropriate specifications prior to blending.
8.41 不合格的批号不能与其他批号混合在一起来达到符合质量标准的目的。混合的每一个批号都应该是用规定的生产工艺生产的，混合前应当单独检测，并符合相应的质量标准。
8.43 Blending processes should be adequately controlled and documented, and the blended batch should be tested for conformance to established specifications, where appropriate. 混合过程应当充分控制并记录，混合后的批号应当根据情况进行测试，以确认是否达到质量标准。
8.44 The batch record of the blending process should allow traceability back to the individual batches that make up the blend.
8.44 混合过程的批记录应当允许追溯到参与混合的每个单独批号。
8.45 Where physical attributes of the API are critical (e.g., APIs intended for use in solid oral dosage forms or suspensions), blending operations should be validated to show homogeneity of the combined batch. Validation should include testing of critical attributes (e.g., particle size distribution, bulk density, and tap density) that may be affected by the blending process. 8.45 如果原料药的物理性质至关重要（例如，用于固体口服制剂或混悬剂的原料药），混合工艺应当验证，以显示混合后批号的均匀性。验证应当包括测试可能受混合过程影响的关键属性（例如，粒度分布，堆密度和振实密度）。
8.46 If the blending could adversely affect stability, stability testing of the final blended batches should be performed.
8.46 如果混合会对稳定性有不良影响，应当对最终混合批号进行稳定性测试。
8.47 The expiry or retest date of the blended batch should be based on the manufacturing date of
the oldest tailings or batch in the blend.
8.47 混合批号的有效期或复验期应当以混合中生产日期最早的尾料或批次的批号为基准。
8.5 Contamination Control 8.5 污染控制
8.50 Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control. Examples include residue adhering to the wall of a micronizer, residual layer of damp crystals remaining in a centrifuge bowl after discharge, and incomplete discharge of fluids or crystals from a processing vessel upon transfer of the material to the next step in the process. Such carryover should not result in the carryover of degradants or microbial contamination that may adversely alter the established API impurity profile.
8.50 在得到充分控制的前提下，上一批号的同一中间体或原料药的剩余物可以带入下几个连续批号。例如，黏附在微粉机壁上的残留，离心出料后残留在离心机筒体内的潮湿的结晶，将物料转至下一步工序时无法从反应器中彻底放尽的物料。此类带入不应当导致因带入降解物或微生物的污染而对已经建立的原料药杂质概况有不良影响。
8.51 Production operations should be conducted in a manner that prevents contamination of intermediates or APIs by other materials.
8.51 生产操作应当防止中间体或原料药被其它物料污染。
8.52 Precautions to avoid contamination should be taken when APIs are handled after purification. 8.52 处理精制后的原料药应当采取预防污染的措施。
9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES
原料药和中间体的包装和贴签 9.1 General 9.1 总则
9.10 There should be written procedures describing the receipt, identification, quarantine, sampling, examination, and/or testing, release, and handling of packaging and labeling materials. 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。
9.11 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 operations for which they are unsuitable.
9.11 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。
9.12 Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or rejected.
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。
9.2 Packaging Materials 9.2 包装材料
9.20 Containers should provide adequate protection against deterioration or contamination of the intermediate or API that may occur during transportation and recommended storage.
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。
9.21 Containers should be 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.
9.21 容器应当清洁，如果中间体或原料药有要求时，应当进行消毒，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。
9.22 If containers are reused, they should be cleaned in accordance with documented procedures, and all previous labels should be removed or defaced.
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。
9.3 Label Issuance and Control 9.3 标签发放与控制
9.30 Access to the label storage areas should be limited to authorized personnel.
9.30 只有获准人员才能进入标签贮存区。
9.31 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 labels issued. Such discrepancies should be investigated, and the investigation should be approved by the quality unit(s).
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 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 prevents mix-ups and provides proper identification.
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。
9.33 Obsolete and out-dated labels should be destroyed. 9.33 废弃的和过期的标签应当销毁。
9.34 Printing devices used to print labels for packaging operations should be controlled to ensure that all imprinting conforms to the print specified in the batch production record.
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。
9.35 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 examination should be documented.
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。
9.36 A printed label representative of those used should be included 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。
9.4 Packaging and Labeling Operations 9.4 包装和贴签操作
9.40 There should be documented procedures designed to ensure that correct packaging materials and labels are used.
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。
9.41 Labeling operations should be designed to prevent mix-ups. There should be physical or spatial separation from operations involving other intermediates or APIs.
9.41 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。
9.42 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 the quality of intermediate or API.
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 If the intermediate or API is intended to be transferred outside the control of the manufacturer’s material management system, the name and address of the manufacturer, quantity of contents, 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 indicated on the label and/or certificate of analysis.
9.43 如果中间体或原料药要向生产商的物料管理系统控制范围以外运输，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。
9.44 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. This examination should be documented in the batch production records, the facility log, or other documentation system.
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。
9.45 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 production or control records.
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。
9.46 Intermediate or API containers that are transported outside of the manufacturer’s control should be sealed in a manner such that, if the seal is breached or missing, the recipient will be alerted to the possibility that the contents may have been altered.
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。 10. STORAGE AND DISTRIBUTION 10.储存和分发 10.1 Warehousing Procedures 10.1 入库程序
10.10 Facilities should be available for the storage of all materials under appropriate conditions (e.g., controlled temperature and humidity when necessary). Records should be maintained of these conditions if they are critical for the maintenance of material characteristics.
10.10 应当提供在适当条件下（需要时控制温度和湿度）贮存所有物料的设施。应当记录对保持物料特性至关重要的贮存条件。
10.11 Unless there is an alternative system to prevent the unintentional or unauthorized use of quarantined, rejected, returned, or recalled materials, separate storage areas should be assigned for their temporary storage until the decision as to their future use has been made. 10.11 除非另有其它系统可以防止待验的、不合格的退回或召回的物料的误用或未经许可擅自使用，应当为其临时存放指定单独的存放区域，直至其今后用途确定为止。
10.2 Distribution Procedures 10.2 分发程序
10.20 APIs and intermediates should only be released for distribution to third parties after they have been released by the quality unit(s). APIs and intermediates can be transferred under quarantine to another unit under the company’s control when authorized by the quality unit(s) and if appropriate controls and documentation are in place.
10.20 原料药和中间体经质量部门放行后才能分发给第三方。经质量部门授权，而且如果有合适的控制并有文件证明，可允许待验的原料药和中间体在公司的控制范围下，转移到另一部门。
10.21 APIs and intermediates should be transported in a manner that does not adversely affect their quality.
10.21 原料药和中间体应当以对其质量不产生负面影响的方式运输。
10.22 Special transport or storage conditions for an API or intermediate should be stated on the label.
10.22 原料药或中间体的特殊运输或贮存条件应当在标签上注明。
10.23 The manufacturer should ensure that the contract acceptor (contractor) for transportation of the API or intermediate knows and follows the appropriate transport and storage conditions. 10.23 生产商应当确保运输原料药或中间体的合同接受方（订约人）了解并遵从相关的运输和贮存条件。
10.24 A system should be in place by which the distribution of each batch of intermediate and/or
美国FDA原料药生产质量管理规范（ 中英文）
