哪些文件根据FDA的CGMP指南必须保存？

julia朱玉姣

Which Records must be kept according to FDA´s cGMP Guide?

哪些文件根据FDA的CGMP指南必须保存？

Some time ago we published a GMP News about the SOPs which are required according to the GMP regulations. This time we will list the records which are demanded by US law. The FDA will demand these records either by paper or by electronic means.

之前我们公布过一个GMP新闻，题为“根据GMP法规要求哪些SOP”。这次，我们要列出美国法律所要求的记录。FDA要求这些记录以电子或纸质的方式保存。

The general requirements for recordkeeping is defined in § 211.180.  The records must be retained for at least 1 year after the expiration date of the batch and, for certain over-the-counter (OTC) drugs, 3 years after distribution of the batch (§ 211.180(a)).  All records mentioned in 21 CFR 211 must be readily available for authorized inspections during the retention period (§ 211.180(c)), and such records may be retained either as original records or as true copies (§ 211.180(d)). In addition, companies may use electronic records. For this the computer system needs to be validated and the special requirements defined in 21 CFR Part 11 on Electronic Records and Signature need to be met.

通用的记录保留要求是在第211.180章中规定的：记录必须保留期最短为该批次有效期加一年，对于非处方药品，为该批次销售完毕后3年（§ 211.180(a)）。所有在21CFR211中提到的记录在其规定的保存时期内（§ 211.180(c)）在官方检查时必须是可以获得的，这些记录可以是保存原件，也可以真实复制件 (§ 211.180(d))。另外，公司可以使用电子记录。对于这种计算机系统，需要进行验证，并符合21CFR第11部分关于电子记录和电子签名的要求。

The following records need to be kept and archived (the following list is taken from a Federal Register Notice:

以下记录需要保留并存档（以下清单来自联邦注册通知）

Section 211.34-. Records about Consultants must be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

第211.34部分----关于顾问的记录必须保留，其中应包括顾问的姓名、地址、资质及所提供的顾问类型。

Section 211.67(c)-Records must be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182.
第211.67(c)部分---在§ 211.180 and 211.182中要求的维保、清洁、消毒和检查的记录必须保存。
Section 211.68(a)-Records must be maintained of calibration checks, inspections, and computer or related system programs for automatic, mechanical, and electronic equipment.
第211.68(a)部分---关于自动化、机械和电子设备的校验检查、检查和计算机或相关系统程序的记录必须保存。
Section 211.68(b)-All appropriate controls must be exercised over all computers or related systems and control data systems to assure that changes in master production and control records or other records are instituted only by authorized persons.
第211.68(b)---必须对所有计算机或相关系统和控制数据系统进行所有适当的控制，以保证对主生产和检验记录及其它记录的变更仅由授权人建立。
Section 211.72-Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use must not release fibers into such products.
第211.72部分---液体用过滤器如用于人用注射级药品生产、加工或包装，则必须是不能掉落纤维至产品中。
Section 211.80(d)-Each container or grouping of containers for components or drug product containers or closures must be identified with a distinctive code for each lot in each shipment received. This code must be used in recording the disposition of each lot. Each lot must be appropriately identified as to its status.
第211.80(d)---每个容器或容器的组合用作药品组件或药品容器密闭器必须在每次接收时对每一批号识别其清晰的代码。该代码必须用于记录每个批号的处理。每个批号必须对其状态进行适当识别。
Section 211.100(b)-Written production and process control procedures must be followed in the execution of the various production and process control functions and must be documented at the time of performance. Any deviation from the written procedures must be recorded and justified.
第211.100(b)---在各生产和工艺控制实施时应遵守书面生产和工艺控制程序，必须在执行时进行记录。所有偏出书面程序的偏差必须进行记录和判定。
Section 211.105(b)-Major equipment must be identified by a distinctive identification number or code that must be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.
第211.105(b)----主要设备必须有清楚的识别编号或代码进行识别，且必须记录在批生产记录中，显示出用于每批药品生产所用的特定设备。如果只有一台特定类型的设备存在于一个生产场所中，可以使用设备名称，用于替代清楚的识别编号或代码。
Section 211.122(c)-Records must be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, or testing.
第211.122（c）---每次收到的不同标识和包装材料的接收、检查或测试的记录必须保存。

julia朱玉姣

Section 211.130(e)-Inspection of packaging and labeling facilities must be made immediately before use to assure that all drug products have been removed from previous operations. Inspection must also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection must be documented in the batch production records.
第211.130(e)---包装和贴标场所在使用前必须进行检查以保证所有之前操作的所有药品已被清出现场。还必须检查以保证所有不会用于后续操作的包装和标签物料已清除出现场。检查结果必须记录在批生产记录上。
Section 211.132(c)-Certain retail packages of OTC drug products must bear a statement that is prominently placed so consumers are alerted to the specific tamper-evident feature of the package. The labeling statement is required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-evident feature chosen is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement.
第211.132(c)部分---特定的非处方药品分销包装必须在明显位置放置声明，这样对消费者警示特定的包装防伪证据。标签声明的放置方式应该在包装弯曲或丢失时，其防伪特性不受影响。如果所选择的防伪证据使用了一种鉴别特征，则在标识声明中应进行引用。
Section 211.132(d)-A request for an exemption from packaging and labeling requirements by a manufacturer or packer is required to be submitted in the form of a citizen petition under 21 CFR 10.30.
第211.132(d)---所有生产商或包装商提请的免除包装和标识要求的申请应根据21CFR10.30的要求以市民请愿的形式提交。
Section 211.137-Requirements regarding product expiration dating and compliance with 21 CFR 201.17.
第211.137部分---关于产品有效期计算和符合21CFR201.17的要求。
Section 211.160(a)-The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, must be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. These requirements must be followed and documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms must be recorded and justified.
第211.160(a)部分---所有质量规格、标准、取样计划、检验方法或其它化验室控制机制的建立，包括其变更必须由适当的部门单位进行起草和审核，并由质量控制部门批准。必须遵守这些要求产在实施时进行记录。所有偏出书面质量规格、标准、取样计划、检验方法或其它化验室控制要求的偏差必须进行记录并判定。
Section 211.165(e)-The accuracy, sensitivity, specificity, and reproducibility of test methods employed by a firm must be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
第211.165(a)部分----公司所用的检验方法必须建立其准确度、灵敏度、专属性和重复性并记录。这些验证和文件记录并须符合§ 211.194(a)(2)的要求。
Section 211.166-Stability testing program for drug products.
第211.166部分---药品的稳定性测度程序
Section 211.173-Animals used in testing components, in-process materials, or drug products for compliance with established specifications must be maintained and controlled in a manner that assures their suitability for their intended use. They must be identified, and adequate records must be maintained showing the history of their use.
第211.173部分----用于测试组件、中间物料或药品符合其既定质量标准的动物的保管和控制方式应能保证其适用于既定用途。这些动物必须进行识别，必须保存充分的记录来显示来用途。
Section 211.180(e)-Written records required by part 211 must be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures must be established and followed for such evaluations and must include provisions for a representative number of batches, whether approved or unapproved or rejected, and a review of complaints, recalls, returned, or salvaged drug products, and investigations conducted under § 211.192 for each drug product.
第211.180(e)部分----第211部分所要求的书面记录必须保存，这样数据可以用于至少每年一次对每种药品质量标准进行评估，以决定是否需要对药品的质量标准或生产或检测程序进行变更。必须建立书面程序，并遵守这些程序进行评估，必须包括相关代表性批次的条款，不管是已批准的还是未批准的或是拒收的批次，以及对客诉、召回、退货或销毁药品的审核，根据第211.192章对每种药品进行的调查。
Section 211.180(f)-Procedures must be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations, conducted under § 211.198, 211.204, or 211.208, any recalls, reports of inspectional observations issued, or any regulatory actions relating to good manufacturing practices brought by FDA.
第211.180（f）部分----必须建立程序以保证公司负责的管理人员，如果其本人并没有涉入或立即知道该行动，会收到根据 § 211.198, 211.204, or 211.208条款所进行的调查、及召回、检查缺陷报告、或所有由FDA采取的与GMP相关的法规行动的书面通知
Section 211.182-Specifies requirements for equipment cleaning records and the use log.
第211.182部分---说明设备清洁记录和使用日志的要求
Section 211.184-Specifies requirements for component, drug product container, closure, and labeling records.
第211.184部分---说明组件、药品容器、密闭器和贴标记录的要求
Section 211.186-Specifies master production and control records requirements.
第211.196部分---说明母版生产和检验记录要求
Section 211.188-Specifies batch production and control records requirement.
第211.188部分----说明批生产和检验记录要求
Section 211.192-Specifies the information that must be maintained on the investigation of discrepancies found in the review of all drug product production and control records by the quality control staff.
第211.192部分----说明必须保存的质量控制人员在所有药品生产和控制记录审核中发现的关于不符合性的调查信息
Section 211.194-Explains and describes laboratory records that must be retained.
第211.194部分---解释并描述必须保存的实验室记录
Section 211.196-Specifies the information that must be included in records on the distribution of the drug.
第211.196部分---说明药品销售记录中所必须包括的信息。
Section 211.198-Specifies and describes the handling of all complaint files received by the applicant.
第211.198---说明并描述申请人收到的所有客诉文件。
Section 211.204-Specifies that records be maintained of returned and salvaged drug products and describes the procedures involved.
第211.204----说明退回和销毁药品的记录必须保存，并要求描述所涉及的流程。

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