Inspection Hosting and Behaviors检查接待及行为规范 In order for audits and inspections to proceed efficiently, there are logistic and hosting activities an organization may identify before an inspection, including informing personnel of their roles.
为确保审计和检查工作的高效开展，组织可在检查前明确相关的后勤与接待安排，并明确相关人员的职责分工。
Reception 接待
Processes should be in place to receive a regulatory inspector. This should take place at the secured main entrance to the facility. The process includes verifying the inspector’s credentials, signing into the facility, notifying management of the inspector’s arrival, and conducting a site safety orientation of the inspectorate staff. Best practice for notification includes a list of individuals and alternates to be notified and the order in which they are notified, or a call tree.
应当制定专门流程以妥善接待监管检查员。该流程应在设施主入口处启动。具体流程包括：核实检查员的资质、在设施内进行登记、及时通知管理层检查员已到访，并对检查员团队进行现场安全简介。最佳通知实践包括：明确列出需通知的人员及候补人员名单，并规定通知顺序，或者采用呼叫树的方式。
The inspector should be greeted by trained audit support personnel in as little time as possible.检查员抵达后，应由经过培训的审计支持人员及时接待。
Rooms 房间
At a minimum one room should be secured to host the inspector. If there are multiple inspectors, it may be beneficial to secure separate rooms for each, if feasible, to avoid confusion caused by multiple conversations occurring at once.
至少应预留一间房间供检查员使用。如果有多个检查员，如果可行的话，为每位检查员预留单独的房间可能会更有利，以避免因同时进行的多场对话而造成混乱。
Inspection hosting best practice includes the use of a backroom or preparation room. The backroom supports inspection management activities such as tracking the inspector’s requests for documentation, preparing SMEs, and formulating responses to inquiries. In addition, the requested documentation is reviewed in the backroom, prior to giving it to the inspector, to ensure the request is addressed properly.
检查接待的最佳实践包括使用后台或准备室。后台支持检查管理活动，例如跟踪检查员的文件需求、准备SME以及制定对询问的回应。此外，在将文件交给检查员之前，会在后台对其进行审核，以确保正确处理了相关文件。
Personnel人员
The following roles are recommended to facilitate a successful inspection:
为确保检查工作的顺利开展，建议配备以下岗位人员：
- Host/Escort – Typically a host or escort is designated for each inspector. This individual serves as the primary liaison with the inspector and remains with them at all times. The inspector should not to be left unescorted within the facility. The host should be familiar with both the company’s quality system and manufacturing operations so that they can field questions without the assistance of SMEs when feasible.
- 主持人/陪同人员-通常应为每位检查员指定一名主持人或陪同人员。该人员作为检查员的主要联络人，并全程陪同其开展工作。检查员在设施内部活动期间不得无人陪同。主持人应熟悉公司的质量管理体系及生产运营流程，以便在必要时能够独立回答相关问题，无需依赖专家支持。
- Scribe – A scribe is assigned to each inspector to record information requests, questions, and discussions. This recorded information is shared with runner and support staff. (Using an electronic system can quickly and efficiently update backroom support personnel.)
- 记录员- 每位检查员都配备一名记录员，负责记录信息请求、问题和讨论的内容。这些记录的信息会与跑腿员和支持人员共享。（使用电子系统可以快速高效地更新后台支持人员的信息。）
- Tour Guide – Typically inspectors and auditors request a tour of the facility. This may be led by one person (and a scribe) with general knowledge of the facility, or a small group in which SMEs are available for the area of focus.
- 导览员-通常检查员和审计员会要求参观设施。这可能由一位对设施有大致了解的人（以及一位记录员）带领，或者由一个小组带领，小组中要有该关注领域的SME。
- Runner and Support Staff – Runners and support staff obtain documents requested by the inspector from the backroom to allow the scribe and host to continue working with the inspector without interruption or delay.
文件传递员与支持人员—文件传递员和支持人员从后台准备室获取检查官所需的文件，确保记录员（scribe）和主接待人（host）能够无干扰、无延误地继续协助检查官开展工作。
- SME – Ideally SMEs are on hand in the backroom. If this is not possible, SMEs are readily available to answer questions and explain processes when needed. SMEs are typically the process owners of the subject to which they will speak.
- SME - 在理想状态下，SME应随时在后台待命。若无法实现此要求，SME也应具备即时回应问题并阐释流程的能力。SME通常是其负责主题的流程负责人。
- Backroom Lead – This lead manages the activities of the backroom and ensures document requests and SME availability are met in a timely manner.
-后台负责人 - 该主管负责管理后台的活动，并确保及时满足文档请求和SME的可用性。
- Interpreter – If necessary, an interpreter/translator should be brought in to help in translating requests from the inspectorate staff.
-口译员-如有必要，应请口译员/笔译员协助翻译检查人员的要求。
Inspection Interaction检查互动
An inspection is a formal process and should be treated as such. The inspector should be addressed andconversed with in a professional and respectful manner. Questions should be answered truthfully without embellishment. If there is uncertainty for an answer, site personnel are advised to not speculate; it is acceptable to take notes on the request and follow-up with an answer later. If it is not clear what the inspector is requesting, discuss the question for clarification.
检查是一项正式程序，应当予以重视。应以专业和尊重的方式与检查员交谈。应如实回答问题，不做任何修饰。如果对答案不确定，建议现场人员不要推测；可以接受的做法是：记录下该请求，并在后续提供答复。如果检查官的要求不明确，应进行讨论以寻求澄清。
7.2 Opportunities for Improvement 改善机会
An early part of a regulatory inspection is usually a tour of the facility, often a specific portion of the facility that could be the focus of the audit. Having available an up-to-date blueprint of the facility, including the layout of the CU, helps to identify the route for the tour.
监管检查的早期阶段通常是参观设施，有时是设施中的特定部分，该部分可能是审核的重点。拥有设施的最新图纸，包括CU的布局，有助于确定参观路线。
The first thing a regulatory inspector or site auditor sees when entering a manufacturing or manufacturing support area is its general physical condition and upkeep. After that, specific areas become apparent, such as wetness; hose handling; equipment and piping design, condition, and tagging; pest control efforts; and the competence and knowledge of the tour guides.
当监管检查官或现场审计员进入生产或生产支持区域时，首先看到的是其整体物理状况和维护状况。随后，会注意到具体方面，例如：潮湿；软管管理；设备与管道的设计、状况和标识；虫害防治措施；以及导览负责人的专业能力与知识水平。
First impressions are important and can set the tone for the audit and where the auditor directs his/her focus thereafter. An unkempt facility implies a disregard for GMP and sensitizes the auditor to look for other poor manufacturing processes or poor GMP attitudes that could directly affect product quality. It should be remembered that anything out of the ordinary, or not as clean as possible, may raise questions from the auditor. If the answers do not alleviate the inspector’s concerns, the focus of the audit may become intent on finding deficiencies. Having a wellmaintained facility that meets a stringent level of cleanliness helps to show that the facility is committed to meeting GMPs.
第一印象至关重要，它不仅为审计定下基调，还会影响审计员后续的关注方向。杂乱无序的设施往往意味着对GMP的忽视，进而促使审计员提高警惕，积极寻找可能直接影响产品质量的不良生产工艺或不当的GMP态度。必须谨记，任何异常情况或未达到应有清洁标准的情况，都可能引发审计员的质疑。若答复无法有效消除检查官的疑虑，审计的重心可能会转向刻意查找缺陷。相反，拥有维护良好且符合严格清洁水平的设施，有助于展示该设施对遵守GMP规范的坚定承诺。
7.2.1 Identifying Opportunities for Improvement 识别改进机会
Sometimes things that an auditor may not typically see may be “normal” for facility personnel since they have lived with or accommodated non-optimal conditions for a long time. Long-term, single-employer personnel and managers are more prone to this than experienced, multiple-employer personnel. There is benefit to preparatory audits conducted by auditors familiar with regulatory expectations but unfamiliar with the facility. One such source could be third-party auditors, possibly by customers of a contract manufacturing operation. Auditors from sister sites within the company as well as consultants could also be used for auditing the facility. The intent of these audits is to identify deficient operations, designs, and other issues at the site that may have been overlooked by site personnel. The findings offer opportunities for the site to address prior to a regulatory audit, if possible, or to develop remediation plans with defined timelines.
有时候，审计员可能不会经常看到的情况，对设施人员来说可能是“正常”的，因为他们长期与非最佳状态共存或已适应了这些状态。与经验丰富、曾在多家雇主工作过的人员相比，长期服务于单一雇主的人员和管理者更容易出现这种情况。由熟悉监管期望但不熟悉该设施的审计员进行预备性审计是有益的。此类审计员的来源可以是第三方审计员，例如合同生产运营的客户。来自公司内部其他工厂的审计员以及顾问也可用于审计该设施。这些审计的目的是识别现场人员可能已忽视的、存在于该场地的不足的操作、设计及其他问题。审计发现为该场地提供了机会，以便在监管审计之前（如有可能）进行整改，或制定带明确时间节点的整改计划。
7.2.2 Tour Guide Competence 导览人员能力
The CUs tour guide should be an SME on the CU, knowledgeable not only of this process but other manufacturing processes as well. If this person is not intimately familiar with the CU system procedures (which may give a negative impression to the auditor), then they may defer an answer until after reviewing the SOP on the subject.
该CU的导览员应当是该CU的SME，不仅对这一流程烂熟于心，对其他制造流程也应具备一定的了解。若导览员对CU系统程序不够熟悉（这可能会给审计员留下不良印象），建议其先查阅相关主题的SOP，然后再进行回答。
There is a delicate balance in the impression given to an auditor by a quick, authoritative verbal response of inaccurate information versus a tentative response deferred to an SOP for verification. If it is a tentative answer from someone who should be a knowledgeable area manager, it implies a lack of understanding of the practices they oversee.
在审计过程中，审计员对于被审计方迅速但不准确的答复，与谨慎推迟至依据标准操作程序进行核实后再作答的做法，能够形成不同的印象。若一位本应熟悉相关业务的区域经理仅提供试探性回答，则可能表明其对所负责的业务流程缺乏深入了解。
7.2.3 SOPs and Logbooks
There should be a company policy that addresses sharing documentation with regulators that should be part of the staff’s training requirements. With respect to CU the policy should allow for sharing of all information. The regulator should be provided with copies of the requested documents, or specific pages.
公司应制定一项政策，规定与监管机构共享文件的要求，且该政策应纳入员工培训要求的一部分。关于CU，该政策应允许共享所有信息。应向监管机构提供所要求文件或特定页面的副本。
During the tour, the auditor may ask for a copy of an SOP associated with an observed practice or operation. The auditor should be informed that a copy of the SOP will be provided after returning to the interview room (if consistent with company policy) unless they want to view it immediately. In this case, the auditor should be shown the SOP utilized by the manufacturing personnel in that area. The accuracy of any verbal response as well as the availability of that SOP in the area where it is executed will be noted by the auditor as another indication of good or poor
在参观过程中，审计员可能会要求提供一份与所观察操作或实践相关的SOP副本。应告知审计员，在返回面谈室后将提供该SOP副本（前提是符合公司政策），除非他们提出立即查看的要求。若审计员要求立即查看，则应向其展示该区域生产人员所使用的SOP。任何口头答复的准确性，以及该SOP在其执行区域的可获取性，都将被审计员记录，作为评估良好或不良GMP实践的重要依据。
The procedures should be the effective versions and may be centrally located, or hanging or posted in the area where they are used. The auditor may note the revision number of the SOP, and after returning to the interview room, may ask for the effective SOP to see if it has the same revision number. If it does not, this is an indication of poor document control. Another indication of poor compliance is the use of locally posted unofficial procedures, such as hand-written notes and reminders. These are another indication of uncontrolled documentation processes.
规程应为当前生效版本，可集中存放，或在其实施区域悬挂或张贴。审计员可能会记录该SOP的版本号，并在返回面谈室后，要求查看当前生效的SOP，以确认其版本号是否一致。若版本号不符，则表明文档控制存在缺陷。另一合规性不佳的迹象是使用本地张贴的非正式规程，如手写便利贴和提醒。这同样是文档流程失控的表现。
The auditor may ask to see a logbook where drain cleaning activities are recorded (which could also reveal an inaccurate verbal response of cleaning frequency). If no logbook or SOP exists for this activity, this negative impression may lead the auditor to conclude that not all manufacturing activities are described in SOPs or recorded in logbooks, and that the activity may be subject to variable execution and frequency.
审计员可能会要求查阅记录排水口清洁活动的日志（这也可能揭示关于清洁频率的口头答复存在不准确之处）。若该活动缺乏相应的日志或标准操作程序（SOP），这种负面印象可能导致审计员得出以下结论：并非所有生产活动都已纳入SOP的描述或在日志中得以记录，且该活动的执行方式和频率可能存在较大的变动性。
Some facilities no longer utilize paper procedures and logbooks; thus, when an auditor requests information found in electronic systems, printouts of the requested information should be provided. Such electronic documentation systems facilitate access to information, so it is less likely for documentation to be lost, misplaced, or outdated as might occur with paper documentation systems. Evidence of compliance to electronic records regulations may be requested.
部分设施不再使用纸质规程和日志；因此，当审计员要求查看电子系统中的信息时，应提供所要求信息的打印件。此类电子文件系统便于信息获取，因此，文件丢失、错放或过时的可能性低于纸质文件系统。可能会被要求提供符合电子记录法规的证据。
Regardless of how SOPs and logbooks are managed, they should be current and readily available for use by area personnel, which in turn makes the requested information readily available for an auditor or inspector.
无论SOP和日志的管理方式如何，它们都应当是现行有效的，并且便于区域人员随时查阅。这样一来，审计员或检查官也能便捷地获取所需信息。
