Q7a
These records should demonstrate that the system is maintained in a validated state.
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.
5.49 Data can be recorded by a second means in addition to the computer system.
6. DOCUMENTATION AND RECORDS 6.1 Documentation System and Specifications
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.
6.11 The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories.
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.
6.13 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.
6.14 When entries are made in records, these should be made indelibly in spaces provided for
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 除计算机系统之外，数据可以用第二种方式记录。
6. 文件和记录
6.1 文件系统和质量标准
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 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 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 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 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
26
Q7a
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.
6.15 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.
6.16 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.
6.17 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.
6.18 If electronic signatures are used on documents, they should be authenticated and secure.
6.2 Equipment cleaning and Use Record
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
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 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 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 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 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 设备的清洁和使用记录
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。
27
Q7a
performed the cleaning and maintenance.
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. 6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials
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 ● The results of any test or examination
preformed and the conclusions derived from this ● Records tracing the use of materials
● Documentation of the examination and
review of API labeling and packaging materials for conformity with established specifications ● The final decision regarding rejected raw
materials, intermediates, or API labeling and packaging materials
6.31 Master (approved) labels should be maintained for comparison to issued labels.
6.4 Master Production Instructions (Master Production and Control Records)
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
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 原料、中间体、原料药的标签和包装材料的记录
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；
● 所进行的任何测试或检查结果，以及由此
得出的结论；
● 跟踪物料使用的记录；
● 检查和审核原料药的标签和包装材料与
规定标准符合度的证明文件；
● 拒收原料、中间体或原料药的标签和包装
材料的最终决定。 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 生产工艺规程（主生产和控制记录） 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。
28
Q7a
person in the quality unit(s).
6.41 Master production instructions should 6.41 生产工艺规程应当包括： include:
如有可● The name of the intermediate or API being ● 要生产的中间体或原料药的名称，
manufactured and an identifying document 能，写明文件编号； reference code, if applicable
● A complete list of raw materials and ● 完整地列出原料和中间体的足以区分任
intermediates designated by names or 何质量特性的名称或代码； codes sufficiently specific to identify any special quality characteristics
● An accurate statement of the quantity or ● 准确说明所用的每种原料或中间体的投
ratio of each raw material or intermediate 料量或投料比，包括计量单位。如果投料to be used, including the unit of measure. 量不是固定的，应当写明每批的批量或产Where the quantity is not fixed, the 率的计算方法。还应当包括经证明是合理calculation for each batch size or rate of 的量的偏差； production should be included. Variations to quantities should be included where they are justified
● The production location and major ● 生产地点及使用的主要设备；
production equipment to be used
● Detailed production instructions, including ● 详细的生产规程，包括：
the: - sequences to be followed - 操作顺序， - ranges of process parameters to be - 工艺参数的范围，
used - sampling instructions and in-process - 取样方法，过程控制及其认可标准，
controls with their acceptance criteria, where appropriate - time limits for completion of - 某些情况下，要说明完成某一工序和
individual processing steps and/or the /或整个工艺过程的时间， total process, where appropriate - expected yield ranges at appropriate - 在某一工艺阶段或时间的预期产率。
phases of processing or time
写明注意事项、要遵循的预防● Where appropriate, special notations and ● 根据情况，
precautions to be followed, or 措施，或它们的相互参照； cross-references to these
包括标● The instructions for storage of the ● 中间体或原料药的适宜贮存规定，
intermediate or API to ensure its suitability 签、包装材料，某些情况下写明特殊的贮for use, including the labeling and 存条件、时间限制，以确保其使用。 packaging materials and special storage conditions with time limits, where appropriate.
29
Q7a
6.5 Batch Production Records (Batch Production and Control Records)
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.
6.51 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.
6.52 Documentation of completion of each significant step in the batch production records (batch production and control records) should include:
● Dates, and when appropriate, times
● Identify of major equipment (e.g., reactors,
driers, mills, etc.) used ● Specific identification of each batch,
including weights, measures, and batch numbers of raw materials, intermediates, or any reprocessed materials used during manufacturing ● Actual results recorded for critical process
parameters ● Any sampling performed
● Signatures of the persons performing and
directly supervising or checking each critical step in the operation ● In-process and laboratory test results
● Actual yield at appropriate phases or times ● Description of packaging and label for
6.5 批生产记录（批生产和控制记录） 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 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。
6.52 在批生产记录（批生产记录和控制记录）中提供每一重要步骤完成的证明，应当包括：
● 日期，某些情况下还有时间； ● 主要设备（如反应釜，干燥器，磨粉机等）
的标识；
● 每一批的识别特征，包括原料、中间体或
任何用于生产的返工物料的重量、计量单位、批号；
● 记录关键工艺参数的实际值；
● 取样；
● 每个关键步骤的操作者和直接指导者或
检查者的签名；
● 过程控制和实验室的测试结果； ● 适当阶段或时间的实际产率；
● 中间体或原料药的包装材料和标签的描
30