GMP/GDP Q&A Guide 3.0来了：计算机化系统与数据完整性有哪些新增与变化？

2026年9月，ECA Academy发布《The GMP/GDP Questions & Answers Guide Version 3.0》。该文件并非新的GMP法规，而是汇集EMA、European Commission、FDA、ICH及ECA Academy等不同来源Q&A的综合性参考文件。与2020年3月发布的Version 2.0相比，Version 3.0在内容和收录范围上都有明显扩展。

本期重点梳理其中与计算机化系统、电子记录、数据完整性、远程访问、电子签名、软件、数据传输及审计追踪相关的新增和修订内容。需要注意的是，Version 3.0中的“新内容”并不都等同于“2026年新增监管要求”，其中既包括新增监管Q&A，也包括既有问答的修订，以及首次被Version 3.0收录的内容。

把这些变化放在一起看，可以看到三个值得关注的趋势：

一是监管关注边界在延伸。
Remote QP表明，关键GMP活动一旦延伸到场址之外，身份、权限、设备、网络、数据传输和电子签名等控制也必须随之延伸。

二是验证关注对象在扩展。
3DP不再只是“验证一个软件”，而是进一步关注3D模型、文件传输、软件验证、软件更新和数据完整性等整条数字链路。

三是合规证明更加关注数据和决策是否可信。
FDA强调CGMP记录不能因存放在HR等其他系统中而规避检查；ICH则进一步强调企业应自行评价软件可靠性。 

可以把这三个变化归纳成一句话：

计算机化系统合规正在从“验证一个系统”，逐步走向“证明支撑GxP活动的整条数字链路持续可信”。

下面回到Version 3.0原文，逐项看看这些新增与变化。

主章节	子章节/问答	变化类型	计算机化系统/数据完整性相关内容	来源属性	页码
1. EMA	1.1.18 Remote batch certification / confirmation by QP	新增Q&A（2023）	远程QP认证/确认的允许性、适用条件；远程访问、权限控制、电子签名、数据传输完整性、MFA及传输加密等最低技术要求	EMA监管Q&A	38–39
1. EMA	1.1.21 Implementation of 3DP technology	新增Q&A（2026）	3D打印涉及的计算机化系统、数据完整性、3D模型确认/验证、文件传输确认、软件验证及软件更新管理	EMA监管Q&A	43–45
4. FDA	Records and Reports – Q3	新增Q&A（2022）	CGMP记录不得因存放在HR、Legal或其他企业认为属于FDA检查范围之外的系统中，而规避FDA依法实施的检查	FDA监管Q&A	155–156
5. ICH	Software Solutions – Q1	修订/强化（2024）	明确增加：企业应通过计算机系统验证研究评价候选软件的可靠性；供应商的“ICH compliant”声明不能替代企业自身评价	ICH协调指南Q&A	188
5. ICH	Knowledge Management – Q5	既有Q&A更新/重新发布	正式知识管理体系并非法规强制要求；可采用结构化方法或IT工具支持知识管理	ICH协调指南Q&A	188
6. ECA Academy	6.4 Bioburden – Q1.10	V3新增收录（源自2022年ECA Bioburden专题Q&A）	生物负载平板计数的同步第二人复核及基于风险评估免除同步复核的数据完整性考虑	ECA Academy专家Q&A	222

1.EMA

1. 欧洲药品管理局

1 1.1.18 Questions and answers on remote batch certification / confirmation by the qualified person (QP) - July 2023

1.1.18 关于质量受权人（QP）远程实施批次放行认证/确认的问答——2023年7月

1.Is remote batch certification / batch confirmation by the QP (i.e. when not at the authorised site address specified on the MIA) allowed?

1.QP不在制造或进口许可证所列授权场址时，是否允许其远程实施批次认证或批次确认？

Remote batch certification / batch confirmation could be allowed if accepted by the national competent authority where the authorised site is located. Some competent authorities may have specific requirements regarding the implementation of remote batch certification / batch confirmation on a routine basis. Manufacturers and QPs should ensure that they comply with any applicable local requirements. In order to determine what requirements apply, manufacturers should consult with their national competent authority.

如果授权场址所在地的国家主管当局接受，则可以允许远程批次认证或批次确认。部分主管当局可能对常规实施远程批次认证或确认规定具体要求。生产商和QP应确保遵守所有适用的当地要求。为确定具体适用要求，生产商应咨询本国主管当局。

2.Where remote QP certification / confirmation is allowed, what conditions should apply?

 2.允许远程QP认证或确认时，应适用哪些条件？

The following points should be taken into consideration:

应考虑以下各点：

 It is a prerequisite that the QP certification/confirmation is carried out in full accordance with EU legislation and EU GMP guidelines.

 首要条件是QP认证或确认完全依照欧盟法律和EU GMP指南实施。

QP certification / confirmation should take place within the EU/EEA (or Northern Ireland) in all cases. This should be demonstrated by technical means.

QP认证或确认在任何情况下均应在欧盟或欧洲经济区内（或北爱尔兰）进行，并应通过技术手段证明这一点。

QPs are obliged to maintain their knowledge in relation to the products, manufacturing processes and pharmaceutical quality system. QPs also need to be satisfied that their ongoing reliance on the relevant pharmaceutical quality system is well founded. The QP must be able to demonstrate to the competent authority knowledge of the product and the manufacturing processes for which they are responsible. This should include time spent physically on-site as applicable.

QP有义务持续掌握产品、生产工艺和药品质量体系相关知识，并确认其持续依赖相关药品质量体系具有充分依据。QP必须能够向主管当局证明其了解所负责的产品和生产工艺；适用时，应包括实际在现场工作的时间。

 Where remote QP certification / confirmation is employed on a routine basis, it must be described and controlled within the pharmaceutical quality system and relevant detailed site procedures should be in place. In Member States where use of contract QPs (i.e. a person who is not an employee of the manufacturer but conducting QP activities under the manufacturer’s authorisation) is permitted, the technical agreement between the MIA holder and the QP should also mention remote certification / confirmation, and specify the circumstances under which the QP must attend the site.

常规采用远程QP认证或确认时，必须在药品质量体系内描述并受控，同时建立详细的场址程序。在允许使用合同QP的成员国，MIA持有人与QP之间的技术协议还应写明远程认证或确认，并规定QP必须到场的情形。

The QP should have access to all information (data and computer system applications) which are necessary according to Annex 16 to make a decision on batch certification / confirmation.

QP应能够访问依据Annex 16作出批次认证或确认决定所需的全部信息，包括数据和计算机系统应用程序。

The MIA holder should provide the required facilities to enable QPs to carry out their functions remotely. This includes the equipment and support required to enable electronic batch certification / confirmation and completion of the batch certification register remotely. IT systems used for remote batch release should comply with requirements of EU GMP Annex 11.

MIA持有人应提供QP远程履职所需的设施，包括支持电子批次认证或确认及远程填写批次认证登记册所需的设备和支持。用于远程批次放行的IT系统应符合EU GMP Annex 11。

All actions carried out by the QP electronically at the remote location should be contemporaneously available for inspection by the competent authorities at the authorised batch release site. It is the responsibility of the MIA holder to guarantee that a) only the QP has editing access to the batch certification function, b) that data being transferred are complete and unchanged and c) an electronic signature, reflecting requirements in annex 11, is in place. QPs must be able to demonstrate that they are fulfilling their wider duties in accordance with Annex 16.

QP在远程地点以电子方式实施的全部操作，应能在授权批次放行场址同步提供给主管当局检查。MIA持有人负责保证：a）只有QP拥有批次认证功能的编辑权限；b）传输数据完整且未被更改；c）配置符合Annex 11要求的电子签名。QP必须能够证明其履行Annex 16规定的更广泛职责。

Compliance with the above points should be verified e.g. as part of the self-inspection programme at the authorized batch release site.

应通过授权批次放行场址的自检方案等方式核实上述要求的符合性。

3.What are the technical terms minimum requirements for the remote access and the signature used for batch certification / confirmation?

3.用于批次认证或确认的远程访问和签名，其最低技术要求是什么？

The risk with regard to IT-security and data integrity for remote access is higher than for access within the controlled environment at the authorized site. Minimum requirements depend very much on the state of technology employed. The following requirements should be adapted to reflect current technological developments. Technical and organisational solutions which are not listed below but result in an appropriate level of security may also be acceptable:

远程访问在IT安全和数据完整性方面的风险高于在授权场址受控环境内访问。最低要求很大程度上取决于所采用技术的现状。以下要求应随当前技术发展作相应调整；未在下方列明、但能达到适当安全水平的技术和组织措施，也可能被接受：

Prior to transfer of any hardware off-site it should be identified and inventoried. It should be ensured that the hardware remains complete and up-to-date. The hard disk should be encrypted and any ports that are not required should be disabled.

任何硬件带离场址前，应予以识别并纳入清单管理；应确保硬件保持完整并及时更新。硬盘应加密，不需要的端口应禁用。

 For QPs who may be using a virtual private network, security parameters on the network operating system, database and application level should be configured appropriately to avoid unauthorised access.

QP使用虚拟专用网络时，应在网络操作系统、数据库和应用程序层面适当配置安全参数，防止未经授权的访问。

Recognised industry standards should be used for authentication and authorisation (e.g. two-factor or multifactor authentication). There should be no use of shared authentication information, and automatic expiry of authentication information should be employed.

身份鉴别和授权应采用公认的行业标准，例如双因素或多因素认证。不得共享身份鉴别信息，并应设置身份鉴别信息自动失效机制。

Data in transfer should be secured by strong transport encryption (e.g. TLS 1.2, https).

传输中的数据应采用强传输加密保护，例如TLS 1.2和HTTPS。

The MIA holder is responsible for putting organisational controls (e.g. assignment of individual privileges) and technical controls in place to ensure that only the QP is able to perform remote batch certification / confirmation.

MIA持有人负责建立组织控制（例如分配个人权限）和技术控制，确保只有QP能够实施远程批次认证或确认。

1.1.21 Implementation of 3DP technology (Additive Manufacturing Technology) for solid oral dosage forms 

1.1.21 3D打印技术（增材制造技术）在口服固体制剂生产中的实施与应用

4.What GMP requirements are relevant and applicable to support the use of 3DP in pharmaceutical manufacturing?

 4.哪些GMP要求与药品生产中使用3D打印相关并适用？

The 3DP manufacturing process generally consists of the following activities: 

3D打印生产过程通常包括：

• Equipment design/qualification/validation (including 3D printing software). 

设备设计、确认和验证（含3D打印软件）；

• Manufacture of the intermediate cartridges/syringes.

中间体料筒或注射器的制造；

 • Printing process, including process control. 

打印及过程控制； 

• Quality control testing. 

质量控制检验；

• Batch certification and release.

批次认证与放行。

Equipment 

设备

The 3D printer, including the computerised systems, as for any other manufacturing equipment, should be designed, located, qualified and maintained to suit its intended purpose in accordance with EU GMP (see for further reference EU GMP Chapter 3, Annexes 11 and 15, and Commission Implementing Regulation 2025/2091 Chapter IV, and Annexes IV and V). A program of maintenance/calibration is required to ensure the good performance of the 3D printer, and this should be in line with the recommendations by the 3D printer manufacturer. In turn, the finished product manufacturer should ensure that the maintenance program is performed. In the event that maintenance activities are outsourced to the 3D printer manufacturer, a contract agreement detailing the respective responsibilities should be in place. A preventive maintenance plan should be established to ensure optimal condition of use and the smooth operation of the 3D printer, and avoid unintentional deviations, equipment malfunctions and production interruptions. Monitoring systems must be in place to detect and resolve potential issues quickly.

3D打印机及其计算机化系统与其他生产设备一样，应根据EU GMP进行设计、选址、确认和维护，使其适合预定用途（进一步参见EU GMP第3章、附录11和附录15，以及欧盟委员会实施条例2025/2091第IV章、附件IV和附件V）。为确保3D打印机性能良好，应建立与3D打印机制造商建议一致的维护和校准方案；成品生产商应确保该维护方案得到执行。维护活动外包给3D打印机制造商时，应签订明确双方责任的合同协议。还应建立预防性维护计划，保证设备处于最佳使用状态并平稳运行，避免非预期偏差、设备故障和生产中断；必须建立监测系统，以便快速发现并解决潜在问题。

Pharmaceutical materials (Cartridges/Syringes) 

药用物料（料筒或注射器）。

Usually, for 3DP, the pharmaceutical materials (active substances, excipients, or their mixtures) are presented in cartridges or syringes. 

在3D打印中，活性物质、辅料或其混合物通常装在料筒或注射器中。

Cartridges/syringes can be manufactured directly by the finished product manufacturer conducting the 3D printing or received ready-to-use from a different manufacturer. The preparation of the active substance(s)/excipient(s) mixture and its filling into the cartridge are considered part of the finished product manufacturing process (intermediate manufacturing), and compliance with Part I of EU GMP guidelines and Commission Implementing Regulation 2025/2091 for products is required by any manufacturer conducting this activity (see references below). 

料筒或注射器可以由实施3D打印的成品生产商直接制造，也可以从其他生产商接收即用产品。活性物质和辅料混合物的制备及其灌装入料筒，被视为成品生产过程的一部分，即中间体生产；任何实施该活动的生产商均须符合EU GMP指南第一部分以及适用于产品的欧盟委员会实施条例2025/2091（见下方参考文献）。

The selection, qualification, approval and monitoring of suppliers of active substances, excipients, starting materials or pharmaceutical containers should be performed according to the EU GMP (see for further reference the Chapters 4, 5 and 7 of the EU GMP, and Chapters V, VI and IX of the Commission Implementing Regulation 2025/2091), and the level of supervision should be proportionate to the risks posed by the individual materials, taking into account of their source, manufacturing process, supply chain complexity and the final use to which the material is put in the medicinal product.

活性物质、辅料、起始物料或药用容器供应商的选择、确认、批准和监测应依照EU GMP进行（进一步参见EU GMP第4章、第5章和第7章，以及欧盟委员会实施条例2025/2091第V章、第VI章和第IX章）。监督程度应与各物料造成的风险相适应，并考虑其来源、生产工艺、供应链复杂程度以及该物料在药品中的最终用途。

Manufacturing process 

生产过程。

The amount of information received from the manufacturer of the 3D printer should be sufficient for the medicinal product manufacturer to fully understand the functioning of the equipment and to identify the process parameters critical for the product. The application of quality risk management (QRM) to the 3D printing process can help to proactively identify and control potential quality issues, and to ensure the expected quality of the 3D printed products is delivered to the patients. QRM should be integrated into existing operations and documented appropriately (see for further reference ICH Q9 R1).

3D打印机制造商提供的信息应足以使药品生产商充分理解设备的运行方式，并识别对产品具有关键性的工艺参数。将质量风险管理用于3D打印过程，有助于主动识别和控制潜在质量问题，并确保向患者提供符合预期质量的3D打印产品。质量风险管理应纳入现有操作并得到适当记录（进一步参见ICH Q9(R1)）。

The high accuracy of deposition (resolution) is an inherent feature of 3DP technology, which is an advantage over other traditional manufacturing methods. The defined process parameters should be monitored and, where necessary, controlled to ensure the process produces products with the desired quality within the validated ranges (see also the pharmaceutical development paragraph in question on quality requirements above for further details).

沉积的高精度（分辨率）是3D打印技术的固有特征，也是其相对于传统生产方法的优势。应监测既定工艺参数，并在必要时加以控制，以确保工艺在经过验证的范围内生产出具有预期质量的产品。更多细节可参见前述质量要求问题中的药品开发部分。

At every stage of manufacturing, products and materials should be protected from microbial and other contamination, including cross-contamination. It should be prevented by appropriate design and maintenance of the premises and equipment, and use of cleaning procedures of validated effectiveness. Risk minimization measures should be proposed, such as the use of disposable material in contact with the product. Dedicated premises or containment may be necessary, according to the QRM, in case of highly active components, toxic or sensitizing materials handling.

在生产的每个阶段，都应保护产品和物料免受微生物及其他污染，包括交叉污染。应通过适当的厂房和设备设计、维护，以及采用有效性经过验证的清洁程序来防止污染。应提出降低风险的措施，例如使用与产品接触的一次性材料。依据质量风险管理结果，在处理高活性成分、有毒物料或致敏物料时，可能需要专用厂房或采取隔离措施。

 Appropriate training should be provided for the personnel according to Chapter 2 of the EU GMP and Chapter III of the Commission Implementing Regulation 2025/2091, considering also the involvement of the 3D printer manufacturer in the personnel training, e.g. file conversions maintenance, equipment uses. 

应按照EU GMP第2章和欧盟委员会实施条例2025/2091第III章对人员进行适当培训，同时考虑由3D打印机制造商参与文件转换、维护和设备使用等方面的人员培训。

Outsourced activities should be appropriately defined, agreed and controlled, according to Chapter 7 of the EU GMP and the Chapter IX of the Commission Implementing Regulation 2025/2091, to ensure the outsourced activities are carried out successfully, e.g. 3D printer manufacturer qualification, maintenance, software update, and modifications to the equipment.

外包活动应按照EU GMP第7章及欧盟委员会实施条例2025/2091第IX章进行适当界定、约定和控制，以确保外包活动成功实施，例如3D打印机制造商确认、维护、软件更新和设备变更。

Qualification and validation 

确认和验证

It is a GMP requirement that pharmaceutical product manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process (see for further reference Annex 15 of EU GMP guidelines and the Annex V of the Commission Implementing Regulation 2025/2091). Use of QRM should ensure that the manufacturer's efforts are focused on the areas of highest risk by addressing CPPs and potential failure modes.

GMP要求药品生产商在产品和工艺的整个生命周期内，通过确认和验证控制其特定操作的关键方面（进一步参见EU GMP附录15和欧盟委员会实施条例2025/2091附件V）。采用质量风险管理时，应通过处理关键工艺参数和潜在失效模式，使生产商把工作集中于最高风险领域。

 It is expected that the 3D printing process (e.g. printing parameters of speeds, temperatures) is validated. The 3D printer, if used to manufacture medicinal products, should be considered pharmaceutical production equipment and should be adequately qualified. Both qualification and validation activities should be completed in accordance with annex 15 of EU GMP guidelines and Annex V of the Commission Implementing Regulation 2025/2091 (see references below). 

3D打印工艺应经过验证，例如打印速度、温度等参数。用于生产药品的3D打印机应被视为制药生产设备，并进行充分确认。确认和验证活动均应按照EU GMP附录15及欧盟委员会实施条例2025/2091附件V完成。

The 3D printing equipment should be used within the recommended settings/conditions of its manufacturer/supplier, unless the in-house operating mode has been fully validated. It is acceptable that 3D printer qualification activities are carried out by the manufacturer/supplier of the printer. Equipment knowledge and understanding from the 3D printer manufacturer are also important for the finished product manufacturer/user for building their own knowledge to support the equipment and process validation and demonstrate that the printing process is capable of consistently producing medicinal products that meet pre-determined quality and performance standards. The collaboration between the users and the pharma ink/printer suppliers is considered also relevant in the case of PAT tools implementation. In the event that qualification/validation activities are outsourced to the 3D printer manufacturer, a contract agreement should be in place (see for further reference Chapter 7 of the EU GMP and the Chapter IX of the Commission Implementing Regulation 2025/2091).

除非企业内部运行模式已经得到充分验证，3D打印设备应在其制造商或供应商推荐的设定和条件下使用。打印机制造商或供应商可以实施3D打印机确认活动。成品生产商或使用方也需要获取并理解打印机制造商掌握的设备知识，以建立自身知识，支持设备和工艺验证，并证明打印工艺能够持续生产符合预定质量和性能标准的药品。在实施过程分析技术工具时，使用方与药用油墨及打印机供应商之间的协作也被认为十分重要。确认或验证活动外包给打印机制造商时，应签订合同协议（进一步参见EU GMP第7章及欧盟委员会实施条例2025/2091第IX章）。

The 3D printer should be cleaned and decontaminated depending on the products being manufactured. The related cleaning processes should be validated, and appropriate procedures should be established. The cleaning of the empty cartridges/syringes should also be validated (see for further reference Chapter 4 and Annex 15 of the EU GMP, and the Chapter V and Annex V of the Commission Implementing Regulation 2025/2091). The use of dedicated/single-use cartridges/syringes could reduce risks of contamination.

应根据所生产的产品对3D打印机进行清洁和去污染；相关清洁工艺应经过验证，并建立适当程序。空料筒或空注射器的清洁也应经过验证（进一步参见EU GMP第4章和附录15，以及欧盟委员会实施条例2025/2091第V章和附件V）。使用专用或一次性料筒、注射器可以降低污染风险。

 A 3D printer is a fully computer-driven system, and compatibility between printer and software is critical to the quality of the final medicinal product. The computer validation should be carried out according to the Annex 11 of the EU GMP guidelines and the annex V of the Commission Implementing Regulation 2025/2091 (see references below), and should include, among others, data integrity management, 3D model design, qualification and validation, qualification of the file transfer to the printer, software validation and software update management. In case Artificial Intelligence (AI) is used in the 3DP, the Annex 22 of the EU GMP guidelines and the EMA Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle should be considered (see references below).

3D打印机是完全由计算机驱动的系统，打印机与软件的兼容性对最终药品质量至关重要。计算机化系统验证应按照EU GMP附录11及欧盟委员会实施条例2025/2091附件V开展（见下方参考文献），并且至少应包括数据完整性管理、3D模型设计及其确认和验证、传输至打印机的文件传输确认、软件验证及软件更新管理。3D打印使用人工智能时，应考虑EU GMP附录22以及EMA《关于在药品全生命周期中使用人工智能的反思文件》（见下方参考文献）。

First published: 24/03/2026

首次发布：2026年3月24日

4. FDA (USA) – Questions and Answers on cGMP Requirements 

4.FDA（美国）——cGMP要求问答

Records and Reports

记录和报告

3.Can a firm demonstrate compliance with current good manufacturing practice (CGMP) by relying on records not accessible to FDA?

▪3.企业能否依靠FDA无法访问的记录来证明符合现行药品生产质量管理规范？

 No. Records that are needed to demonstrate compliance with current good manufacturing practice (CGMP records) are subject to FDA inspection under section 704(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 1 Consequently, records that are not subject to review and inspection by FDA (which may include certain records maintained solely outside the quality system2) cannot be relied upon to demonstrate compliance with CGMP requirements.

不能。用于证明符合现行药品生产质量管理规范的记录，即CGMP记录，依据《联邦食品、药品和化妆品法》第704(a)条属于FDA检查范围。因此，不接受FDA审阅和检查的记录（其中可能包括仅保存在质量体系之外的某些记录）不能用于证明符合CGMP要求。

▪FDA has observed that some firms maintain certain details relating to product quality complaints and investigations (e.g., records related to the details of a discrepancy and its related investigation) only in a record system that they consider largely out of scope of FDA’s inspectional authority, such as a human resources (HR) filing system containing personnel data. The HR filing system at a firm may include qualification information for technical and professional personnel performing functions subject to FDA regulation. FDA has the authority to inspect such records to the extent that they relate to adherence to the CGMP requirement for qualified personnel. FDA also has the authority to inspect records related to produc t quality complaints and investigations. Records related to employee qualifications and product quality complaints and investigations may be included in an HR filing system. However, CGMP records, whether related to training, discrepancies, or related follow-up actions, should not be retained solely in a filing system that a firm considers largely out of scope of FDA’s inspectional authority. Records and other information relating to CGMP must be retained (e.g., in an appropriate CGMP records management system) such that records are available for inspection by FDA and subject to FDA’s authority to inspect. 

FDA发现，一些企业把与产品质量投诉和调查有关的某些细节，例如差异详情及相关调查记录，只保存在其认为基本不属于FDA检查权限范围的记录系统中，例如包含人事资料的人力资源档案系统。企业的人力资源档案系统可能包含从事FDA监管职能的技术和专业人员的资质资料；只要这些记录涉及是否遵守CGMP关于人员资质的要求，FDA就有权检查。FDA也有权检查与产品质量投诉和调查有关的记录。员工资质、产品质量投诉和调查记录可能被纳入人力资源系统，但与培训、差异或相关后续措施有关的CGMP记录，不应仅保存在企业认为基本不属于FDA检查权限范围的档案系统中。CGMP相关记录和其他信息必须以FDA能够检查并可依法行使检查权的方式保存，例如保存在适当的CGMP记录管理系统中。

A firm may adopt any appropriate filing system that it chooses and may file information FDA has the authority to inspect with records generally excluded from such authority. However, under section 704(a) of the FD&C Act, FDA investigators may ask a firm to provide CGMP records that may be contained in such files. If the firm denies FDA access to such records that the agency has authority to inspect, this may constitute a limitation of inspection under section 501(j) of the FD&C Act. Examples of limiting an inspection include (1) not providing certain requested CGMP records that FDA has authority to inspect on the grounds that such records are inaccessible because they are in an HR or other filing system that a firm considers largely out of scope of FDA’s inspectional authority; and (2) not providing certain CGMP records that FDA has authority to inspect because such records were generated by legal counsel and therefore the firm considers they are not obligated to provide such information. Instead, the firm could redact any information that FDA would not have authority to access, review, and copy. See the guidance for industry Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. 11/16/2022

企业可以自行选择并采用任何适当的档案管理系统，也可以将FDA依法有权检查的信息，与通常不属于FDA检查权限范围的记录一并归档保存。但是，根据《联邦食品、药品和化妆品法》（FD&C Act）第704(a)条，FDA检查员可以要求企业提供可能包含在此类档案中的CGMP记录。如果企业拒绝FDA查阅其依法有权检查的这些记录，则根据FD&C Act第501(j)条，这种行为可能构成对检查的限制。构成限制检查的情形包括，例如：企业以某些被要求提供的CGMP记录存放在人力资源（HR）系统或其他企业认为基本不属于FDA检查权限范围的档案系统中，因此“无法访问”为由，拒绝提供FDA依法有权检查的相关CGMP记录；企业以某些FDA依法有权检查的CGMP记录是由法律顾问生成，因此认为企业没有义务向FDA提供这些信息为由，拒绝提供相关记录。对于这类情况，企业可以采取的做法是：对FDA无权访问、审查或复制的信息进行适当遮蔽，而不是拒绝提供整份记录。另请参见FDA行业指南：《构成延迟、拒绝、限制或拒不接受药品检查的情形》日期：2022年11月16日

5. ICH – Questions and Answers on ICH Q7, Q8, Q9 and Q10

5. ICH——ICH Q7、Q8、Q9 和 Q10 问答

Knowledge management

知识管理

 5.Do regulatory agencies expect to see a formal knowledge management approach during inspections?

5.监管机构是否期望在检查中看到正式的知识管理方法？

No. There is no regulatory requirement for a formal knowledge management system. However, it is expected that knowledge from different processes and systems is appropriately utilised. Note: “formal” in this context means a structured approach using a recognised methodology or (IT-) tool, executing and documenting something in a transparent and detailed manner.

不要求。目前不存在必须建立正式知识管理体系的法规要求，但企业应适当利用来自不同工艺和系统的知识。 注：此处“正式”是指采用公认的方法或IT工具，以结构化方式实施某项活动，并进行透明、详细的记录。

Software solutions

软件解决方案

1.Is it necessary for a pharmaceutical firm to purchase products that are marketed as “ICH compliant solutions” or ICH Q8, 9 & 10 Implementation software, etc. to achieve a successful implementation of these ICH guidelines within their companies?

1.制药企业是否必须购买标称为“ICH合规解决方案”或“ICH Q8、Q9和Q10实施软件”等产品，才能在企业内成功实施这些ICH指南？

 No. ICH has not endorsed any commercial products and does not intend to do so. ICH is not a regulatory agency with reviewing authority and thus does not have a role in determining or defining “ICH compliance” for any commercial products. If considering such products, firms will need to carry out their own evaluation of these products relative to their business needs. Computer system validation studies should be performed by companies to evaluate the reliability of potential software.

不必须。ICH没有认可任何商业产品，也无意这样做。ICH不是具有审评权限的监管机构，因此不负责确定或定义任何商业产品是否“符合ICH”。企业考虑使用此类产品时，应结合自身业务需求自行评价，并应通过计算机系统验证研究评价候选软件的可靠性。

6. ECA Academy

6.ECA Academy（欧洲合规学院）

6.4 Bioburden – Regulatory Expectations and Practical Experiences Q&As

6.4生物负载——监管期望与实践经验问答

1.10.Regulatory expectations related to bioburden data integrity. Second verifier analyst requirement for plate counting?

1.10.关于生物负载数据完整性的监管期望：平板菌落计数是否需要第二名分析人员复核？

In theory, yes. For some bioburden sampling points the contemporaneous verification could be waived based on a risk assessment. Guidance for such a risk assessment provides BioPhorum’s RISK ASSESSMENT OF TRADITIONAL CULTURE-BASED MICROBIOLOGICAL TESTS REQUIRING CONTEMPORANEOUS VERIFICATION. The current draft of the revision of USP <1117> follows this philosophy.

 原则上需要。对于某些生物负载取样点，可以基于风险评估免除同步复核。BioPhorum的《需要同步复核的传统培养法微生物试验风险评估》为此类风险评估提供了指导；当前USP <1117>修订草案也采用这一理念。

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