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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.

 

檢查在臺前和臺后都需要進行準備。準備室是用來培訓和指導員工的。這種互動保證了良好的溝通和強烈的團隊歸屬感。迎接檢查是一項團隊運動，每個團隊成員都要付出100%的努力，這樣才能在前臺進球。

 

Front office

 

前臺

 

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".

 

前臺是檢查員在檢查期間停留的檢查室，由接受檢查的公司員工負責。這個房間有時被稱為“作戰(zhàn)室”。但是，檢查不能升級為“戰(zhàn)爭”，不妨稱之為“檢查室”。

 

These are the front office roles:

 

以下是前臺人員的角色:

 

Responsible inspection lead

 

負責檢查引導

 

Minute taker

 

記錄員

 

Subject matter experts     (SMEs)

 

主題專家（SME）

 

Runner

 

信息傳遞人員

 

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.

 

與后臺的溝通對于前臺開展工作非常重要。這由信息傳遞員來確保，但更重要的是通過技術(shù)支持。技術(shù)支持用于確保后臺辦公室的團隊成員確切地知道前臺辦公室正在發(fā)生什么。

 

Back office

 

后臺

 

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.

 

后臺辦公室應在檢查室的旁邊。后臺辦公室通常比較大，有足夠的架子空間存放為檢查準備的文件。每一份送到前臺的文件都要事先到后臺進行核對。因此，后臺辦公室是每一個GMP檢查的重要依靠。后臺辦公室團隊的規(guī)模取決于檢查的復雜性和檢查人員的數(shù)量。對于簡單的檢查，有時你根本不需要后臺辦公室。

 

The following roles in the back office must be assigned:

 

后臺必須分配以下角色:

 

Back office management

 

后臺管理員

 

SMEs back office

 

后臺的SME

 

Runner

 

信息傳遞員

 

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:

 

后臺辦公室為前臺辦公室提出的問題提供答案。因此，后臺辦公室的專家必須非常熟悉質(zhì)量問題。工作包括:

 

Researching documents

 

查找文件

 

Providing documents

 

提供文件

 

Examining and checking     documents

 

檢查和核對文件

 

Laying out documents in     readiness

 

迅速準備好文件

 

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文件通常在檢查開始前幾天送達后臺辦公室。因此，它們可以在檢查過程中迅速找到。后臺辦公室也提供對質(zhì)量部門IT系統(tǒng)的訪問。有經(jīng)驗的檢查專員了解后臺辦公室提供的支持，并經(jīng)常在討論結(jié)束后訪問后臺辦公室，感謝那里的人員提供的支持。

 

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.

 

后臺團隊必須做好充分準備，以確保在檢查過程中能夠支持前臺。它應該提前明確自己的職責，因為在日常繁忙的檢查和前廳的大量問題中，這通常是不可能的。圖21.D-11和圖21.D-12展示了檢查的特點，后臺辦公室的人員必須知道誰負責哪項任務(wù)。如果后臺辦公室的工作流程和職責得到適當?shù)囊?guī)范，這將反映在檢查過程中信息的順暢流動上。

 

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

圖 21.D-11前臺與后臺的互動

 

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

圖21.D-12前臺與后臺互動示例

 

Preparation room

 

準備室

 

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".

 

準備室是位于后臺辦公室和前臺辦公室之間的等候室。技術(shù)專家在這個房間里做好準備，在他們“進入”前可以得到一些最后的指示。

 

The preparation room has a     number of different functions:

 

準備室有幾個不同的功能：

 

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

 

技術(shù)專家可以在安靜的氛圍中做好準備(后臺辦公室通常非常繁忙)。

 

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?

 

技術(shù)專家為前臺的情況做好準備。氣氛如何？哪些行為得到了積極的回應？應該避免什么？

 

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.

 

準備室的支持應留給團隊成員，并要求內(nèi)部安靜。這樣，專家們就可以從最后一刻的緊張中解脫出來，集中精力做好手頭的工作。

 

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

 

準備室還應提供通信平臺的接入，以便實現(xiàn)與前后臺之間的通信。

 

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.

 

技術(shù)專家在前臺作報告后，也在準備室收集經(jīng)驗。這樣，準備室就可以用作訓練室，讓專家們?yōu)榍皬d的氣氛做好準備。

 

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.

 

準備室不是強制性的，但它是一個很好的地方，可以在進入前臺之前逃離后臺辦公室的部分繁忙的氣氛。