Section 13, Change Control.
7.14 关键原料的供应商的变更应当参照第13章“变更控制”进行。
7.2 Receipt and Quarantine 7.2接收和待验
7.20 Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labeling (including correlation between the name used by the supplier and the in-house name, if these are different), container damage, broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined, or tested, as appropriate, and released for use.
7.20 一旦收到物料而尚未验收，应当目测检查物料每个或每组包装容器的标签是否正确（包括如果供应商所用名称与内部使用的名称不一致，应当检查其相互关系）、容器是否损坏、密封处和开启证据有无破裂或污染。物料应当存放的待验区，直至它们被取样、检查或酌情测试，并放行使用。
7.21 Before incoming materials are mixed with existing stocks (e.g., solvents or stocks in silos), they should be identified as correct, tested, if appropriate, and released. Procedures should be available to prevent discharging incoming materials wrongly into the existing stock.
7.21 在进厂的物料与现有的库存（如储仓中的溶剂或货物）混合之前，应当确认货是否对、必要时进行测试并放行。应当有程序来防止把来料错放到现有的库存中。
7.22 If bulk deliveries are made in nondedicated tankers, there should be assurance of no cross-contamination from the tanker. Means of providing this assurance could include one or more of the following:
对于非专用槽车运送的大宗物料，应当确保没有来自槽车的交叉污染。可用以下的一种或几种方法来提供这种保证：
7.23 Large storage containers and their attendant manifolds, filling, and discharge lines should be appropriately identified.
7.23 大的储存容器及其随附的管路、填充和排放管都应当适当标明。
7.24 Each container or grouping of containers (batches) of materials should be assigned and identified with a distinctive code, batch, or receipt number. This number should be used in recording the disposition of each batch. A system should be in place to identify the status of each batch.
7.24 每个或每组物料容器（几批）的物料都应当指定并标上编号、批号或接收号。此号码应当用于记录每批的处置情况。应当有一个识别每批状态的系统。
7.3 Sampling and Testing of Incoming Production Materials 7.3 进厂物料的取样与测试
7.30 At least one test to verify the identity of each batch of material should be conducted, with the exception of the materials described below. A supplier’s certificate of analysis can be used in place of performing other tests, provided that the manufacturer has a system in place to evaluate suppliers.
7.30 除了7.32中指出的物料，对于每批物料至少要做一个鉴别试验。在生产商对供应商有一套审计体系的前提下，供应商的分析报告可以用来替代其他项目的测试。
7.31 Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications. Complete analyses should be conducted on at least three batches before reducing in-house testing. However, as a minimum, a complete analysis should be performed at appropriate intervals and compared with the certificates of analysis. Reliability of certificates of analysis should be checked at regular intervals.
7.31 对供应商的核准应当包括一次评估，提供足够的证据（如过去的质量记录）证明该生产商始终都能提供符合质量标准的物料。在减少内部测试之前至少应当对三批物料作全检。然而，最低限度每隔一定时间应当进行一次全检，并与分析报告进行比较。分析报告的可靠性应当定期进行检查。
7.32 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer’s certificate of analysis is obtained, showing that these raw materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers should help in establishing the identity of these materials. The lack of on-site testing for these materials should be justified and documented.
7.32 工艺助剂、有害或剧毒的原料、其它特殊物料、或转移到公司控制范围内的另一个部门的物料不用测试，前提是能取得生产商的分析报告，证明这些原料符合规定的质量标准。对容器、标签和批号记录进行目测检查应当有助于鉴别这些原料。对这些物料不作现场测试应当说明理由，并用文件证明。
7.33 Samples should be representative of the batch of material from which they are taken. Sampling methods should specify the number of containers to be sampled, which part of the container to sample, and the amount of material to be taken from each container. The number of containers to sample and the sample size should be based on a sampling plan that takes into consideration the criticality of the material, material variability, past quality history of the supplier, and the quality needed for analysis.
7.33 取样应当能代表被取的那批物料。取样方法应当规定：取样的容器数，取样部位，每个容器的取样量。取样容器数和取样量应当根据取样方案来决定。取样方案的制定要综合考虑物料的重要程度、变异性、供应商过去的质量情况，以及分析需用量。
7.34 Sampling should be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials.
7.34 应当在规定的地点，用规定的方法取样，以避免取样的物料被污染，或污染其它物料。
7.35 Containers from which samples are withdrawn should be opened carefully and subsequently reclosed. They should be marked to indicate that a sample has been taken.
7.35 被取样的容器应当小心开启，随后重新密封。这些容器应当做标记表明样品已抽取。
7.4 Storage 7.4储存
7.40 Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
7.40 物料的搬运和贮存应当防止降解、污染和交叉污染。
7.41 Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate, suitably spaced to permit cleaning and inspection.
7.41 纤维板桶、袋子或盒装物料应当离地贮存，并根据情况留出适当空间便于清洁和检查。
7.42 Materials should be stored under conditions and for a period that have no adverse effect on their quality, and should normally be controlled so that the oldest stock is used first.
7.42 物料应当在对其质量没有不良影响的条件下和时限内贮存，而且通常应当加以控制，做到先进先出。
7.43 Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use.
7.43 某些装在适当容器中的物料可以存放在室外，只要识别标签保持清晰，而且容器在开启和使用前进行适当清洁。
7.44 Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorized use in manufacturing.
7.44 不合格物料应当做标识，并用隔离系统控制，已防止未经许可而用于生产。
7.5 Re-evaluation 7.5重新评估
7.50 Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after prolonged storage or exposure to heat or humidity).
7.50 应当根据情况对物料进行重新评估以便确定其使用的适合性（例如长期存放或暴露于热或潮湿的环境中）。
8. PRODUCTION AND IN-PROCESS CONTROLS 8. 生产和过程控制 8.1 Production Operations 8.1 生产操作
8.10 Raw materials for intermediate and API manufacturing should be weighed or measured under appropriate conditions that do not affect their suitability for use. Weighing and measuring devices should be of suitable accuracy for the intended use.
8.10 用于生产中间体和原料药的原料应当在适宜的条件下称重或测量，以便不影响其使用的适合性。称重和测量装置应当有适合于其用途的精度。
8.11 If a material is subdivided for later use in production operations, the container receiving the material should be suitable and should be so identified that the following information is available:
8.11 如果某物料分出一部分留待以后的生产操作中使用，应当用适合的容器来盛装该物料，并应当标明下列信息：
8.12 Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.
8.12 关键的称重、测量或分装操作应当有人作证或接受相应的控制。使用前，生产人员应当确认该物料是要生产的中间体或原料药的批记录中指定的。
8.13 Other critical activities should be witnessed or subjected to an equivalent control.
8.13 其它关键活动应当有人作证或接受相应的控制。
8.14 Actual yields should be compared with expected yields at designated steps in the production process. Expected yields with appropriate ranges should be established based on previous laboratory, pilot scale, or manufacturing data. Deviations in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.
8.14 在生产过程中的指定步骤，实际收率应当与预计的收率作比较。具有合适范围的预计收率应当根据以前的实验室、中试规模或生产的数据来确定。应当调查与关键工艺步骤有关的收率偏差，以确定其对相关批号最终质量的影响或潜在影响。
8.15 Any deviation should be documented and explained. Any critical deviation should be investigated.
8.15 任何偏差都应当记录，并作解释。任何关键的偏差应当作调查。
8.16 The processing status of major units of equipment should be indicated either on the individual units of equipment or by appropriate documentation, computer control systems, or alternative means.
8.16 应当标明主要设备的生产状态，可以标在每个设备上，或者用文件、计算机控制系统或其它替代的方法。
8.17 Materials to be reprocessed or reworked should be appropriately controlled to prevent unauthorized use.
8.17 对需要进行返工或重新加工的物料应当适当地加以控制，防止未经许可就使用。
8.2 Time Limits 8.2 时限
8.20 If time limits are specified in the master production instruction (see 6.40), these time limits should be met to ensure the quality of intermediates or APIs. Deviations should be documented and evaluated. Time limits may be inappropriate when processing to a target value (e.g., pH adjustment, hydrogenation, drying to predetermined specification) because completion of reactions or processing steps are determined by in-process sampling and testing.
8.20 如果生产工艺规程（见6.40）中规定了时限，应当遵守这些时限，以保证中间体和原料药的质量。所有偏差都要有记录并解释原因。在加工到一个目标值时（例如，调节pH、氢化、干燥到预定标准），时限可能就不合适了，因为反应或加工步骤的完成是取决于过程中的取样和测试的。
8.21 Intermediates held for further processing should be stored under appropriate conditions to ensure their suitability for use.
8.21 留作进一步加工的中间体应当在适宜的条件下储存，以保证其适宜于使用。
8.3 In-process Sampling and Controls 8.3 工序间的取样和控制
8.30 Written procedures should be established to monitor the progress and control the performance of processing steps that cause variability in the quality characteristics of intermediates and APIs. In-process controls and their acceptance criteria should be defined based on the information gained during the developmental stage or from historical data.
8.30 应当制定书面程序来监测会造成中间体和原料药质量特性变异的工艺步骤的进程，并控制其生产情况。工序间控制及其接受标准应当根据项目开发阶段或者以往的生产数据来确定。
8.31 The acceptance criteria and type and extent of testing can depend on the nature of the intermediate or API being manufactured, the reaction or process step being conducted, and the degree to which the process introduces variability in the product’s quality. Less stringent in-process controls may be appropriate in early processing steps, whereas tighter controls may be appropriate for later processing steps (e.g., isolation and purification steps).
8.31 综合考虑所生产中间体和原料药的特性，反应类型，该工序对产品质量影响的程度大小等因素来确定可接受的标准，检测类型和范围。前期生产的中间体控制标准可以松一些，越接近成品，中间控制的标准越严（如分离，纯化）。
8.32 Critical in-process controls (and critical process monitoring), including control points and methods, should be stated in writing and approved by the quality unit(s).
8.32 关键的中间控制（和工艺监测），包括控制点和方法，应当书面规定，并经质量部门批准。
8.33 In-process controls can be performed by qualified production department personnel and the process adjusted without prior quality unit(s) approval if the adjustments are made within pre-established limits approved by the quality unit(s). All test and results should be fully documented as part of the batch record.
8.33 中间控制可以由合格的生产部门的人员来进行，而调节的工艺可以事先未经质量部门批准，只要该调节在由质量部门批准的预先规定的限度以内。所有测试及结果都应当作为批记录的一部分全部归档。
8.34 Written procedures should describe the sampling methods for in-process materials, intermediates, and APIs. Sampling plans and procedures should be based on scientifically sound sampling practices.
8.34 应当制定书面程序，说明中间物料、中间体和原料药的取样方法。取样方案和程序应当基于科学合理的取样实践。
8.35 In-process sampling should be conducted using procedures designed to prevent contamination of the sampled material and other intermediates or APIs. Procedures should be established to ensure the integrity of samples after collection.
8.35 工序间取样应当按能防止污染所取的样品、其它中间体或原料药的程序进行。应当制定保证样品收集后的完整性的程序。
8.36 Out-of-specification (OOS) investigations are not normally needed for in-process tests that
美国FDA原料药生产质量管理规范（ 中英文）
