critical component of the system. These records should demonstrate that the system is maintained in a validated state.
5.47 对计算机化系统所作的变更应当按照变更程序进行，并应当经过正式批准、记录成文并作测试。所有变更记录都应当保存，包括对系统的硬件、软件和任何其它关键组件的修改和升级。这些记录应当证明该系统维持在验证过的状态。
5.48 If system breakdowns or failures would result in the permanent loss of records, a back-up system should be provided. A means of ensuring data protection should be established for all computerized system.
5.48 如果计算机的故障或失效会导致记录的永久丢失，则应当提供备份系统。所有计算机化的系统都应当有数据保护措施。
5.49 Data can be recorded by a second means in addition to the computer system. 5.49 除计算机系统之外，数据可以用第二种方式记录。
6. DOCUMENTATION AND RECORDS 6. 文件和记录
6.1 Documentation System and Specifications 6.1 文件系统和质量标准
6.10 All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures. Such documents can be in paper or electronic form.
6.10 与中间体或原料药生产有关的所有文件都应当按照书面程序进行拟定、审核、批准和分发。这些文件可以是纸张或电子形式。
6.11 The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories.
6.11 所有文件的发放、修订、替换和收回应当通过保存修订历史来控制。
6.12 A procedure should be established for retaining all appropriate documents (e.g., development history reports, scale-up reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records). The retention periods for these documents should be specified.
6.12 应当制订一个保存所有适用文件（如开发历程报告、扩产报告、技术转移报告、工艺验证报告、培训记录、生产记录、控制记录和分发记录）的程序。应当规定这些文件的保存期。
6.13 All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.
6.13 所有生产、控制、销售记录都应保留至该批的有效期后至少一年。对于有复验期的原料药，记录应当保留至该批全部发出后三年。
6.14 When entries are made in records, these should be made indelibly in spaces provided for such entries, directly after performing the activities, and should identify the person making the
entry. Corrections to entries should be dated and signed and leave the original entry still legible. 6.14 做记录时，应当在刚做操作活动后就在所提供的空白处以不易擦掉的方式填写，并标明填写者。修改记录时应当注明日期、签名并保持原来的记录仍可识读。
6.15 During the retention period, originals or copies of records should be readily available at the establishment where the activities described in such records occurred. Records that can be promptly retrieved from another location by electronic or other means are acceptable.
6.15 在保存期间，记录的原件或副本都应保留在记录中描述的活动发生的地方。能以电子或其它方式从另一地点即时恢复的记录也可以接受。
6.16 Specifications, instructions, procedures, and records can be retained either as originals or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques such as microfilming or electronic records are used, suitable retrieval equipment and a means to produce a hard copy should be readily available. 6.16 质量标准、指令、规程和记录保存方式可以是原件，或者真实的副本如影印本、缩微胶卷、缩微平片，或其它原始记录的准确复制件。在使用压缩技术如缩微胶卷或电子记录时，应当有适当的制备纸张副本的恢复设备和方法。
6.17 Specifications should be established and documented for raw materials, intermediates where necessary, APIs, and labeling and packaging materials. In addition, specifications may be appropriate for certain other materials, such as process aids, gaskets, or other materials used during the production of intermediates or APIs that could critically affect quality. Acceptance criteria should be established and documented for in-process controls. 6.17 应当制订原料、中间体（必要时）、原料药和标签及包装材料的质量标准。此外，应当为工艺助剂、垫圈，或中间体或原料药生产中使用的能决定性地影响质量的物料制订质量标准。中间控制应当制定可接受的标准，并成文备查。
6.18 If electronic signatures are used on documents, they should be authenticated and secure.6.18 如果文件采用电子签名，它们应当经过证实，并且确保其安全可靠。
6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录
6.20 Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment and the person who performed the cleaning and maintenance.
6.20 主要设备的使用、清洁、消毒和/或灭菌和保养记录应当记有日期、时间（如有必要的话）、产品、设备中加工的每批批号以及进行清洁和保养的人。
6.21 If equipment is dedicated to manufacturing one intermediate or API, individual equipment records are not necessary if batches of intermediate or API follow in traceable sequence. In case where dedicated equipment is employed, the records of cleaning, maintenance, and use can be part of the batch record or maintained separately.
6.21 如果设备专门用于一种中间体或原料药的生产，而且该中间体或原料药的批号有可追溯性的顺序，那就不需要有单独的设备记录。专门设备的清洁、保养及使用记录可以作为批记录的一部分或单独保存。
6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.3 原料、中间体、原料药的标签和包装材料的记录
6.30 Records should be maintained including:The name of the manufacturer, identity, and quantity of each shipment of each batch of raw materials, intermediates, or labeling and packaging materials for API’s; the name of the supplier; the supplier’s control number(s), if known, or other identification number; the number allocated on receipt; and the date of receipt 6.30 需保存的记录应当包括： 每次到货的每批原料、中间体、原料药标签和包装材料的生产商的名称，标识和数量；供应商的名称、供应商的管理编号，或其它识别号码；物料接收编号和接收日期；
6.31 Master (approved) labels should be maintained for comparison to issued labels. 6.31 标准标签（已批准的）应当保留，用来与发放的标签作比较。
6.4 Master Production Instructions (Master Production and Control Records)
6.4 生产工艺规程（主生产和控制记录）
6.40 To ensure uniformity from batch to batch, master production instructions for each intermediate and API should be prepared, dated, and signed by one person and independently checked, dated, and signed by a person in the quality unit(s).
6.40 为确保批与批的一致性，每种中间体和原料药的生产工艺规程应当由一人拟定、注明日期并签名，并由质量部门的另一人独立进行检查、填写日期和签名。
6.5 Batch Production Records (Batch Production and Control Records)
6.5 批生产记录（批生产和控制记录）
6.50 Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch production record should be checked before issuance to ensure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction. If the batch production record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used.
6.50 应当为每种中间体和原料药准备批生产记录，内容应当包括与各批生产和控制有关的完整资料。批记录发放之前，应当检查版本是否正确，是否是相应生产规程的准确明了的再现。如果批生产记录是按主文件的另一独立部分制定的，该文件应当包括对现行的生产工艺规程的参考。
6.51 These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the production code together with the date and time can serve as the unique identifier until the final number is allocated.
6.51 批记录在发放时应当有一个唯一的批号或标识号，有日期和签名。连续生产时，在最终批号确定前，可以将产品代码、日期和时间结合起来作为唯一的识别符。
6.53 Written procedures should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet specifications. The investigation should extend to other batches that may have been associated with the specific failure or deviation. 6.53 应当建立并执行一种书面程序，对在符合规格上有重大偏差或不合格的一批中间体或原料药进行调查。调查还应当延伸到与这批失误或偏差有关的其它批号。
6.6 Laboratory Control Records 6.6 实验室控制记录
6.60 Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays, as follows:
A description of samples received for testing, including the material name or source, batch number or other distinctive code, date sample was taken, and, where appropriate, the quantity and date the sample was received for testing
A statement of or reference to each test method used
A statement of the weight or measure of sample used for each test as described by the method; data on or cross-reference to the preparation and testing of reference standards, reagents and standard solutions
A complete record of all raw data generated during each test, in addition to graphs, charts and spectra from laboratory instrumentation, properly identified to show the specific material and batch tested
A record of all calculations performed in connection with the test, including, for example, units of measure, conversion factors, and equivalency factors
A statement of the test results and how they compare with established acceptance criteria The signature of the person who performed each test and the date(s) the tests were performed
The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards 6.60 实验室控制记录应当包括从为了确保符合规定的规格和标准所做的所有测试中得到的下列完整的数据，包括下列检验和测定：
所收到检测样品的描述，包括物料名称和来源、批号或其它编号、取样日期，某些情况下记录收到样品的量和时间；
每个所用检测方法的陈述或参引；
按方法描述的所用样品重量或计量；标准品、试剂和标准溶液的配制和测试的数据或相互参考；
除了正确地标明所测试的特定物料和批号的实验室仪器的图谱、图表和光谱外，还有一套从每次测试得到的所有原始数据的完整记录；
与测试有关的所有计算记录，包括测量单位、转换因子以及等量因子等； 检测结果的陈述以及与规定的认可标准的比较； 每项测试的操作者的签名以及测试的日期；
日期和第二个人的签名，表明对原记录的准确性、完整性和规定的标准的符合性已复核过。
6.7 Batch Production Record Review 6.7批生产记录审核
6.70 Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labeling, to determine
compliance of the intermediate or API with established specifications before a batch is released or distributed.
6.70 应当制定并执行审核和批准批生产记录和实验室控制记录，包括包装和贴签的书面程序，以便放行或分发前确定中间体或原料药是否符合规定标准。
6.71 Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. Production and laboratory control records of noncritical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
6.71 在一批原料药放行或分发之前，关键工序的批生产记录和实验室控制记录应当由质量部门审核和批准。非关键性工序的生产和实验室控制记录可按照经质量部门批准的程序，由有资格的生产人员或其它部门审核。
6.72 All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released.
6.72 在批放行前，所有偏差，调查和不合格报告都应当作为批记录的一部分进行审核。
6.73 The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company.
6.73 质量部门可将发放中间体的职责和权力委派给生产部门，运往生产商控制范围以外的中间体除外。
7. MATERIALS MANAGEMENT 7. 物料管理 7.1 General Controls 7.1 控制通则
7.10 There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of materials.
7.10 应当有书面程序阐明物料的接收、鉴别、待验、贮存、搬运、取样、测试和批准或拒收。
7.11 Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
7.11 原料药和/或中间体生产商应当有对关键原料供应商的评估系统。
7.12 Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the quality unit(s).
7.12 应当根据已确定的规格从经过质量部门核准的一个或多个供应商处购买物料。
7.13 If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer.7.13 如果关键物料的供应商不是该物料的生产商，原料药或中间体的生产商应当获知该物料生产商的名称和地址。
7.14 Changing the source of supply of critical raw materials should be treated according to
美国FDA原料药生产质量管理规范( 中英文)
