如何准备GMP检查：GMP检查的台前和幕后！

GMP Inspections: Organisation of the Front and Back Office

GMP检查的前台和后台

The inspection is carried out in the front office and prepared in the backoffice. The preparation room is used to train and instruct staff. Thisinteraction guarantees excellent communication and a strong sense of being partof a team. An inspection is a team sport and each team member gives 100% sothat goals can be scored in the front office.

检查在台前和台后都需要进行准备。准备室是用来培训和指导员工的。这种互动保证了良好的沟通和强烈的团队归属感。迎接检查是一项团队运动，每个团队成员都要付出100%的努力，这样才能在前台进球。

Front office

前台

The front office is the inspection room where the inspectors stay duringthe inspection and are looked after by the staff of the company undergoinginspection. The room is sometimes referred to as the „war room“. However, aninspection must not escalate into a "war", so it is better to speakof an "inspection room".

前台是检查员在检查期间停留的检查室，由接受检查的公司员工负责。这个房间有时被称为“作战室”。但是，检查不能升级为“战争”，不妨称之为“检查室”。

These are the front office roles:

以下是前台人员的角色:

• Responsible inspection lead

• 负责检查引导

• Minute taker

• 记录员

• Subject matter experts     (SMEs)

• 主题专家（SME）

• Runner

• 信息传递人员

  
  

Communication with the back office is important for the work carried outin the front office. This is ensured by the runner, but even more so throughtechnical support. Technical support is used to make sure that the team membersin the back office know exactly what is happening in the front office.

与后台的沟通对于前台开展工作非常重要。这由信息传递员来确保，但更重要的是通过技术支持。技术支持用于确保后台办公室的团队成员确切地知道前台办公室正在发生什么。

Back office

后台

The back office is a room that should be directly beside the inspectionroom. The back office is generally larger with adequate shelf space fordocuments that are prepared for the inspection. Each document that is moved tothe front office is checked in the back office beforehand. The back office istherefore the mainstay of every GMP-inspection. The size of the back officeteam depends on the complexity of the inspection and the number of inspectors.For simple inspections, sometimes you don't need a back office at all.

后台办公室应在检查室的旁边。后台办公室通常比较大，有足够的架子空间存放为检查准备的文件。每一份送到前台的文件都要事先到后台进行核对。因此，后台办公室是每一个GMP检查的重要依靠。后台办公室团队的规模取决于检查的复杂性和检查人员的数量。对于简单的检查，有时你根本不需要后台办公室。

The following roles in the back office must be assigned:

后台必须分配以下角色:

• Back office management

• 后台管理员

• SMEs back office

• 后台的SME

• Runner

• 信息传递员

The back office provides answers to the questions that arise in the frontoffice. It is therefore necessary that the experts located in the back officeare extremely familiar with quality issues. The work includes:

后台办公室为前台办公室提出的问题提供答案。因此，后台办公室的专家必须非常熟悉质量问题。工作包括:

• Researching documents

• 查找文件

• Providing documents

• 提供文件

• Examining and checking     documents

• 检查和核对文件

• Laying out documents in     readiness

• 迅速准备好文件

  
  

Important QA, QC and QM documents are normally brought to the back officedays before the inspection begins. As a result, they can be quickly retrievedduring the inspection. Access to the IT systems of the departments responsiblefor quality is also provided in the back office. Experienced Inspectors areaware of the support provided by the back office and often visit it after theconcluding discussion to thank personnel there for their support.

重要的QA、QC和QM文件通常在检查开始前几天送达后台办公室。因此，它们可以在检查过程中迅速找到。后台办公室也提供对质量部门IT系统的访问。有经验的检查专员了解后台办公室提供的支持，并经常在讨论结束后访问后台办公室，感谢那里的人员提供的支持。

The back office team must prepare itself properly to ensure it can supportthe front office during the inspection. It should clarify its responsibilitiesin advance, because this is generally not possible during the hectic day-to-daybusiness of the inspection and dozens of queries from the front office. Thesituation outlined in Figure 21.D-11 and Figure 21.D-12 is characteristic of aninspection, and personnel in the back office must know who is responsible forwhich tasks. If the workflow and responsibilities in the backoffice are properly regulated, this will be reflected in the smooth flow ofinformation during the inspection.

后台团队必须做好充分准备，以确保在检查过程中能够支持前台。它应该提前明确自己的职责，因为在日常繁忙的检查和前厅的大量问题中，这通常是不可能的。图21.D-11和图21.D-12展示了检查的特点，后台办公室的人员必须知道谁负责哪项任务。如果后台办公室的工作流程和职责得到适当的规范，这将反映在检查过程中信息的顺畅流动上。

Figure 21.D-11 Interaction between front and back office, © Thomas Peither

图 21.D-11前台与后台的互动

Figure 21.D-12 Example for the interaction between front and back office

图21.D-12前台与后台互动示例

Preparation room

准备室

The preparation room is a waiting room located between the back office andthe front office. Technical experts prepare themselves in this room and can begiven some final pointers before their "entrance".

准备室是位于后台办公室和前台办公室之间的等候室。技术专家在这个房间里做好准备，在他们“进入”前可以得到一些最后的指示。

The preparation room has a     number of different functions:

准备室有几个不同的功能：

• Technical experts can     prepare themselves in the quiet atmosphere (the back office is often     extremely hectic).

• 技术专家可以在安静的氛围中做好准备(后台办公室通常非常繁忙)。

• Technical experts are     prepared for the situation in the front office. How is the atmosphere?     Which behaviours have been positively received? What should be avoided?

• 技术专家为前台的情况做好准备。气氛如何？哪些行为得到了积极的回应？应该避免什么？

• The support in the     preparation room should be left to team members with the inner quiet     required. In this way, the experts can be relieved of their last-minute     nerves so they can concentrate on the job at hand.

• 准备室的支持应留给团队成员，并要求内部安静。这样，专家们就可以从最后一刻的紧张中解脱出来，集中精力做好手头的工作。

• Communication platform access     should also be available in the preparation room so that the communication     between the front and back-office can be followed.

• 准备室还应提供通信平台的接入，以便实现与前后台之间的通信。

The experiences of the technical experts also are collected in thepreparation room after their presentations in the front office. In this way,the preparation room is used as a coaching room to prepare the experts for theatmosphere in the front room.

技术专家在前台作报告后，也在准备室收集经验。这样，准备室就可以用作训练室，让专家们为前厅的气氛做好准备。

The preparation room is not mandatory, but it is a good place to escapethe partly hectic atmosphere in the back office before entering the frontoffice.

准备室不是强制性的，但它是一个很好的地方，可以在进入前台之前逃离后台办公室的部分繁忙的气氛。