英语翻译价格
如何准备GMP检查
How to prepare for an inspection?
如何准备检查
What does the ideal preparation look like?
理想的检查是怎么样的？
1. Information
信息
As one of the first steps, it is important that the management and all staff members of the business units concerned are informed about the nature, scope and date of an upcoming inspection as soon as it is known.
作为第一步，重要的一点是，一旦知道即将进行的检查的性质，范围和日期，应立即通知与业务单位相关的管理层和所有员工。
2. Team formation
形成团队
For the next step, various teams should be formed (the size of the teams depends on the size of the company/ site to be inspected). The core team, usually led my the quality assurance unit or directly by the Responsible Person for GMP (RP), manages the preparations and prioritis tasks, coordinates the contact persons and reports directly to nior management.
对于下一步，应该组建不同的团队（团队的规模取决于被检查公司的规模）。核心团队通常由质量保证部门主导或直接由GMP负责人（RP）负责管理准备工作和重点任务，协调联系人和直接向高级管理层报告。
cynical3. Gap analysis
toolbar差距分析
While preparing, all facilities, equipment, systems and documents are analyd for possible deficiencies. The quality assurance unit resp. the RP should support the facilities and areas concerned. Need for improvement should be identified and, if possible, derived measures should be taken. If the elimination is not possible before the inspection is due, the problem should be described and an action plan should be developed. This way, it can be proven to the authority that the deficiency has already been identified and addresd.
在准备过程中，分析所有设施，设备，系统和文件可能存在的缺陷。质量保证部门或GMP负责人应对相关设施和区域提供支持。应该确定需要改进的地方，如果可能的话，应该采取相应的措施。如果在检查到期之前无法消除，应该说明问题并制定行动计划。这样，可以向当局证明缺陷已经被识别和处理。
Mock Audit may be helpful
模拟检查也许有帮助
4. Preparation of documents
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文件准备
The following documents and summaries should always be prepared and to be supplied during an inspection:
应准备下列文件和总结，并在检查时提供：
∙organisation overview and chart,
组织架构图
∙job descriptions,
工作介绍
∙training documentation,
培训文件
∙important SOPs (e.g. on personal, hygiene, deviation management, compliant and recall
pigtailhandling, handling of returns, change control, etc.),
重要的SOP（例如人员，卫生，偏差管理，合规和召回处理，退货处理，变更控制等）
∙layout plans and overviews (also for technical equipment such as HVAC systems),
布局和概述（包括HVAC系统等技术设备）
∙list pf products,
列出pf产品
∙validation and qualification documents,
验证和确认文件
∙summary of deviations, complaints and recalls,
对偏差，投诉和 召回的总结
5. Detailed planning
air horn详细计划
Depending on the business size, the following functions need to be determined:
根据业务规模，需要确定以下职能：
cd14Inspection management: main contact person for the inspector, co-ordinates the inspection (usually the RP or a reprentative of the quality assurance unit);
检查管理：接触检查员的主要人员，协调检查（通常是RP或质量保证部门人员）;
Experts (SME; Subject Matter Expert): reprentatives of each area are prepared to answer questions on the issue in question;
专家（SME：主题专家）：专长于某个领域，准备回答检查过程中提出的相关问题;
For large companies/inspections:
对于大型的公司/检查：
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Inspection coordinator: lead of the coordination room, coordinates the enquires, appoints experts and supervis all documents;
- 检查协调员：协调室的负责人，协调检查员的问题，指派专家回答并监督所有文件;
- Scribe: records the progress of the inspection, writes down questions and enquiries of the inspectors and documents their processing;
- 抄写员：记录检查进度，记录检查员的问题和问询，并记录处理情况;
- Runner: delivers enquiries from the inspection room to the coordination room.
- 传递员：将检查室的问题传递给协调室。
6. Training
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培训
Another important component is the training of all persons involved in an inspection. All persons involved should be specifically trained for their tasks.
另一个重要组成部分是培训所有参与检查的人员。所有相关人员都应接受专门的培训。
7. Beginning of inspection
检查开始
To avoid surpris, the duration, scope and agenda of the planned inspection should be addresd at its beginning. A short prentation by nior management of not more than 10 slides introducing the company resp. the site does not only save time, but also supplies the inspector with important information and a possibility to make a positive first impression. The applicable safety and hygiene regulations may also be addresd here.
为避免意外，检查拟定的持续时间，范围和日程应在一开始时予以确定。高级管理人员用不超过10张幻灯片简短地介绍公司。这不仅节省时间，还为检查员提供了重要的信息，并有可能给予积极的第一印象。适用的安全和卫生规定也可以在这里解决。
