Ref. CFR | Related Title
相关标题 | Issue/ Observation 问题/发现项 |
21CFR, 211.22(d) 21CFR， 211.22（d） | Responsibilities of quality control unit-Written procedure shall be followed.
质量控制单位的职责-应遵循书面程序。 | · Procedure applicable to the quality shall be in writing and shall be followed.
· 适用于质量的程序应采用书面形式，并应遵循。· The responsibilities and procedures applicable to the quality control are not in writing and/or fully followed.
[This is one of the topmost deficiencies in last 9 years
· 适用于质量控制的责任和程序未以书面形式和/或完全遵循。 consistently, remains to be on top in last 9 years]
[这是过去9年来最大的缺陷之一，在过去9年中仍然处于领先地位] |
21CFR 211.192 21CFR 211.192 | o Production record review- Investigation of discrepancies.
o生产记录审查 - 差异调查。 | · Deficiency on Investigations of discrepancies, failures or inadequacy in investigation process.
·调查过程中的差异、失败或不足的不足。 · Unexplained discrepancy in case of failure of batch/components where batch is already distributed.
·在批产品/组分失效的情况下，无法解释的差异，其中批次已经分销上市。 [This remains to be 2nd top-most deficiency in last 9 years around 950 times]
[这仍然是过去 9 年来第 2 大缺陷，约 950次]
|
21CFR 211.42(c) 21CFR 211.42（c）
21 CFR 211.42(c)(10)(iii)
21 CFR 211.42（c）（10）（iii） | o Design and construction features-Facilities shall include defined area with sufficient size.
o设计和施工特征 - 设施应包括具有足够大小的指定区域。 | · Firm failed to provide sufficient space /layout for proper operation (in planned sequence /workflow) and for orderly placement of required equipment.
·公司未能提供足够的空间/布局以进行正常运行（按计划/工作流程）和有序放置所需设备。· Your firm failed to establish an adequate air supply particulate air filters under positive pressure in the aseptic processing areas.
·贵公司未能在无菌加工区域建立足够的正压供气微粒空气过滤器。 |
21CFR 211.160(b) 21CFR 211.160（b）
21CFR 211.110(a) 21CFR 211.110（a） | o General requirements- Lab controls should include scientifically sound specifications.
o一般要求 - 实验室控制应包括科学合理的规范。
o Sampling and testing of in-process and final product.
o过程中产品和最终产品的取样和测试。 | · Deficiency on Scientifically sound laboratory controls/ sampling procedure (e.g. Specifications/standards/ sampling plan/ test procedure.)- either controls/procedures not well defined or not followed by the concerned personnel.
·缺乏科学合理的实验室控制/取样程序（例如规格/标准/抽样计划/测试程序）- 控制/程序未明确定义或有关人员未遵守。 |
21CFR 21CFR
211.100(a) | o Written procedures deviations-Production and process controls shall be supported by written procedure.
o书面程序偏差 - 生产和过程控制应由书面程序支持。 | · Absence of Written Procedures.
·没有书面程序。 · There is no written procedure (production and process to assure product purity, identity, strength and quality.
·没有书面程序（生产和过程，以确保产品的纯度，特性，规格和质量。 |
21CFR 211.67(a) 21CFR 211.67（a）
21CFR 211.67(b) 21CFR 211.67（b） | o Equipment cleaning and maintenance.
o设备清洁和维护。 | · Written procedure is not established or followed for equipment cleaning and maintenance including utensils used in manufacturing, processing, packing or holding of drug product.
·未建立或遵循设备清洁和维护的书面程序，包括用于制造、加工、包装或保存药品的器具。 |
21CFR 211.188 21CFR 211.188 | o Master production and control records-Accurate reproduction included Dates not included for each significant step.
o主生产和控制记录 - 包括准确的复制 不包括每个重要步骤的日期。
o Identification of persons involved each significant step.
o确定每个重要步骤的涉及人员。 | · Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
·每批药品的批生产和检验记录不包括对相应主生产或检验记录的准确复制，该记录经过准确性检查，注明日期并签名。· Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced.
·批生产和检验记录不包括对每批药品的[执行][直接监督][检查]操作中每个重要步骤的人员的识别。· Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.
·批生产和检验记录不包括在加工过程中产生的每批药品中使用的组分的重量。· Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced.
·批生产和检验记录不包括每批药品的批次[制造][加工][包装][持有]中每个重要步骤的日期。 |
21CFR 211.25(a) 21CFR 211.25（a）
21CFR 211.25(b) 21CFR 211.25（b）
21CFR 211.25© 21CFR 211.25© | o Personnel qualification- GMP Training Frequency
o人员资格 - GMP培训频率
o Supervisor Training/Education/Experience
o主管培训/教育/经验
o Inadequate number of personnel
o人员数量不足 | · GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.
·GMP培训没有[持续][足够频繁]进行，以确保员工熟悉适用于他们的CGMP要求。· Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
·负责监督药品[制造][加工][包装][持有]的个人缺乏[教育][培训][经验]来履行其分配的职能，以确保药品具有其声称或代表拥有的安全性，特性，强度，质量和纯度。· The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product.
·有资质的人员的数量不足以[执行][监督]每种药品的[制造][加工][包装][保存]。· Personal Job descriptions are not fully defined and/qualification documentation not properly managed for each role in the organization.
·个人职位描述未完全定义，/或资格文档未针对组织中的每个角色进行适当管理。· Training records are not sufficient / well maintained/ manual interventions in ELMS system.
·ELMS系统中的培训记录不足/被良好维护/人工干预。 |
21CFR 21CFR
211.110(a) | o Sampling and testing of in-process and final product
o过程中产品和最终产品的取样和测试 | · Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch.
·未[建立][遵循]书面程序来描述对每批在制品材料的适当样品进行[过程中控制][测试][检查]。· Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
·未建立控制程序来[监控输出][验证性能]那些可能导致过程中材料和药品特性变化的制造过程。 |
21CFR 21CFR
211.165(a) | o Testing and release for distribution - Appropriate lab tests
o测试和发布分发 - 适当的实验室测试
shall be used to determine the conformance to specification
应用于确定是否符合规范 | · Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.
·用于分销的药品的测试和放行不包括在上市前对[最终规格][每种活性成分的特性和强度]的满意一致性进行适当的实验室测定。 |
21CFR 21CFR
211.100(a)
21CFR 21CFR
211.100(b) | o Written procedures; deviations-Contemporaneous documentation of activities.
o书面程序;偏差 - 活动的同时记录。
o Absence of Written Procedures.
o 没有书面程序。
o SOPs not followed /documented.
o未遵循/记录SOP。
o Procedure Deviations Recorded and Justified.
o记录和证明程序偏差。
o Approval and review of procedures
o程序的批准和审查
o Procedure Deviations not Recorded and Justified
o未记录和证明程序偏差 | Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. 书面生产和过程控制程序未[在执行生产和过程控制功能时遵循][记录执行时间]。
· Your firm failed to establish [adequate] written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
·贵公司未能为生产和过程控制建立[充分]书面程序，以确保药品具有声称或代表拥有的特性，强度，纯度和质量。· Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].
·书面生产和过程控制程序未[在执行生产和过程控制功能时遵循][记录执行时间]。· Deviations from written production and process control procedures are not [recorded] [justified].
·与书面生产和过程控制程序的偏差没有[记录][合理]。· Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].
·书面程序未[由适当的组织单位起草、审查和批准][由质量控制单位审查和批准]。· Deviations from written production and process control procedures are not [recorded] [justified].
·与书面生产和过程控制程序的偏差没有[记录][合理]。 |
21CFR 211.68 21CFR 211.68 | o Automatic mechanical and electronic equipment- Written
o自动机电设备-书面
calibration / inspection records not kept.
不保留校准/检查记录。
o Written record not kept of program and validation data.
o未保留程序和验证数据的书面记录。
o Backup file not maintained.
o备份文件未维护。
o Computer control of master formula records Automatic, mechanical, and electronic equipment
o主配方记录的计算机控制 自动、机械和电子设备
(Access management to the computerized system)
（计算机化系统的访问管理） | · Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
·不保留自动、机械或电子设备（包括计算机或相关系统）的[校准检查][检查]记录。· A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
·在计算机化或其他自动化过程消除备份数据的情况下，未保留程序的书面记录以及适当的验证数据。· Failure to maintain a backup file of data entered into the computer or related system.
·无法维护输入计算机或相关系统的数据的备份文件。· Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
·不对计算机或相关系统进行适当的控制，以确保主生产和控制记录或其他记录的更改仅由授权人员进行。· Non-alignment over the written procedure and performed activity.
·书面程序和执行的活动不一致。 · Firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.
·公司未能对计算机或相关系统进行适当的控制，以确保只有授权人员才能更改主生产和控制记录或其他记录。· The accuracy of Excel spreadsheets used to calculate product assay analytical results not verified. ·用于计算产品测定分析结果的Excel电子表格的准确性未经验证。· Analysts have the ability to access and delete raw data required to conduct any specific testing.
·分析师能够访问和删除执行任何特定测试所需的原始数据。· Regular and complete backup procedure of required data from computer and related systems not available.
·定期和完整地备份来自计算机和相关系统的所需数据不可用。· Alternate backup copies to keep data safe, complete and secure from alteration/loss not available.
·备用备份副本，以确保数据安全、完整和安全，防止无法更改/丢失。· Multiple usernames and passwords for software login of several users’ information were handwritten in an uncontrolled notebook of your senior executive microbiologist.
·用于软件登录的多个用户名和密码 多个用户的信息手写在高级执行微生物学家不受控制的笔记本中。· Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to establish and follow written procedures for the operation and maintenance of your computerized systems
·未能对计算机化系统进行足够的控制以防止未经授权的访问或更改数据，以及未能建立和遵循计算机化系统的书面操作和维护程序· To provide evidences of sufficient verification done by second person(usually SME and QA)
·提供由第二人（通常是领域专家和QA）进行充分验证的证据· User with administrative privileges (access to change parameters) performing testing activities as an operator.
·具有管理权限（有权更改参数）的用户，以操作员身份执行测试活动。· Absence of an activated audit trail to record information about each analytical test, such as:
·缺少激活的审计跟踪来记录有关每个分析测试的信息，例如：§ Date and time 日期和时间
§ Identity of analyst 分析师的身份
§ Nature of action taken and reason
所采取行动的性质和理由
· Training software is not aligned with the training procedure, and not validated as per intended functionalities.
·培训软件与培训程序不一致，并且未根据预期功能进行验证。 |
21 CFR 820.70(i) 21 CFR 820.70（i） | o Production and o生产和
process control- 过程控制-
Documentation of 的文档
software validation. 软件验证。 | · Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented
·作为[生产][质量体系]一部分的计算机或自动数据处理系统的软件验证活动和结果尚未[充分]记录· Firm failed to validate computer software for its intended use according to an established protocol.
·公司未能根据既定方案验证计算机软件的预期用途。· Software system has not been fully validated per the Process Validation Procedure.
·软件系统尚未按照过程验证程序进行全面验证。· There was no protocol specific method used to document acceptance criteria and how the validation will be completed in the Software and Systems Validation Protocol.
·没有特定的方法来记录验收标准以及如何在软件和系统验证方案中完成验证。· There is no documented evidence of design changes were verified and/or validated prior to implementation.
·没有书面证据表明在实施之前验证和/或验证了设计变更。· There is no evidence that testing was done after the implementation of each software code changes.
·没有证据表明在实施每个软件代码更改后进行了测试。· The software does not display error codes to the operators when process parameters are not met.
·当不满足过程参数时，软件不会向操作员显示错误代码。· There is no documented evidence that software testing and/or testing have been conducted for the firm’s all the equipments.
·没有书面证据表明已经对公司的所有设备进行了软件测试和/或测试。 |
21 CFR 820.90(a) 21 CFR 820.90（a） | o Control of nonconforming product.
o不合格品的控制。 | · During production and quality inspection, nonconforming product is identified as a “reject”.While rejected/nonconforming product is identified, documented, and segregated, the firm is not evaluating the nonconformance to determine the need for an investigation and notification of persons or organizations responsible for the nonconformance
·在生产和质量检查过程中，不合格产品被识别为“拒绝放行”。虽然对拒绝放行/不合格产品进行识别、记录和隔离，但公司不会评估不合格品以确定是否需要调查和通知对不合格负责的个人或组织 |
21
CFR820.100(a)
(1) | o Corrective and preventive action.
o纠正和预防措施。 | · CAPA system fails to identify “rejects” as nonconforming product and therefore misses all nonconforming product during the manufacturing process as a quality data input for the CAPA system.
·CAPA系统无法将“拒绝放行”产品识别为不合格品，因此在制造过程中错过所有不合格品作为CAPA系统的质量数据输入。· Procedure and/ implementation of comprehensive assessment and CAPA plan for computer system security and integrity not available.
·计算机系统安全性和完整性的综合评估和CAPA计划的程序和/实施不可用。 |
21 CFR11 21 CFR11 | o Electronic Records and Electronic Signature- Computerized systems.
o电子记录和电子签名 - 计算机化系统。 | · Firm failed to ensure that their experimental data, observations of discrepancies, and discrepancy resolutions are accurately recorded and verified.
·公司未能确保其实验数据、差异观察和差异分辨率得到准确记录和验证。· Firm failed to provide standard operating procedures as well as documentation that is in accordance with their established requirements for
comprehensive, accurate, reliable, and consistent performance of their computer systems.
·公司未能提供符合其既定要求的标准操作程序和文件，确保其计算机系统的全面、准确、可靠和一致的性能。
· Failure to validate computer software for its intended use according to an established protocol.
·未能根据既定方案验证计算机软件的预期用途。· Software system has not been fully validated per the Process Validation Procedure.
·软件系统尚未按照过程验证程序进行全面验证。· There was no protocol specific method used to document acceptance criteria and how the validation will be completed in the Software and Systems Validation Protocol.
·没有特定的方法来记录验收标准以及如何在软件和系统验证协议中完成验证。· The validation of the system was criticized for not being complete and that critical issues (deviations) had not been closed
·系统的验证被批评为不完整，关键问题（偏差）尚未解决· Your system does not display accurate clock dates on the evidences of testing.
·您的系统未在测试证据上显示准确的时钟日期。· Your electronic batch records allowed changes to be made to manual entries prior to saving. Our inspector observed that production person alter the reported time that as operation was performed. QA did not review audit trails as part of their batch record review to identify discrepancies and compare the reported date and time against that was originally logged.
·您的电子批次记录允许在保存之前对手动条目进行更改。我们的检查员观察到，生产人员改变了执行操作时的报告时间。QA 没有在批记录审查中审查审计跟踪，以识别差异并将报告的日期和时间与最初记录的时间进行比较。· Your lab analyst destroyed KF raw data paper printouts associated with drug products were discovered by inspection team in trash bag.
·您的实验室分析师销毁了卡尔费休的原始数据纸打印件，检查小组在垃圾袋中发现了与药品相关的原始数据纸打印输出。· Gap assessment done for computerized systems shows number of upgrades required in the systems e.g. access control with authorization, audit trail with complete information of action performed, saving electronic data, prevention of clock alteration but no CAPA closure documented.
·对计算机化系统进行的差距评估显示了系统中所需的升级数量，例如具有授权的访问控制，具有所执行操作的完整信息的审计跟踪，保存电子数据，防止时钟更改，但未记录了CAPA关闭。 |
