ECA-污染控制策略指南（中英文）-202202

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Foundation

Fostering harmonisation

ofGMP/GDPregulations

How to Develop and Document a

Contamination Control Strategy

如何制定和编制污染控制策略

-ECA Task Force on Contamination Control Strategy-

-ECA 污染控制策略工作小组-

Foundation

Fostering harmonisation

ofGMP/GDPregulations

1. Background 背景介绍 ..................................................................................................................... 4

2. Introduction 简介 ...............................................................................................................................5

3. Contamination Control Strategy (CCS )- the Elements listed in Annex 1 污染控制策略(CCS)

—附录1 中所列的要素 ....................................................................................................................... 8

4. Development and Documentation of a Company 's CCS 公司CCS 的开发和编制............. 10

5. Responsibilities /Ownership 职责/所有权 ..................................................................................... 27

6. Future challenges in the holistic evaluation of the CCS performance 对CCS 性能进行整体评

价的未来挑战 ....................................................................................................................................... 28

附件....................................................................................................................................................... 30

附件 1: 差距评估实例 ( 非详尽无遗 )............................................................................................. 30

附件2: CCS 内容表的例子 ............................................................................................................... 30

附件 3: 污染控制策略文件的模板 ( 示例 ) ................................................................................... 30

Foundation

Fostering harmonisation

ofGMP/GDPregulations

1. Background 背景介绍

For pharmaceutical manufacturers and their suppliers,contamination of any kind that leads to product

or production losses represents a significant risk.As recent events in the past,such as foreign

particulate contamination

(https://www.fiercepharma.com/pharma/contaminant-moderna-covid-19-vaccine-vials-

found-japan-was-metallic-particles-report),have shown,this can lead to supply bottlenecks for

individual medicinal products or groups of medicinal products.

对于制药商及其供应商来说，导致产品或生产损失的任何形式的污染都代表着一种重大风险。

正如最近发生的事件，如外来微粒污染

(https://www.fiercepharma.com/pharma/contaminant-moderna-covid-19-vaccine-vials-found-japan-

was-metallic-particles-report) 所示，这可能导致个别药品或药品组的供应瓶颈。

Manufacturers should design their production facilities,equipment,and processes and implement

Quality Risk Management(QRM)to ensure appropriate contamination control to minimize or detect

contamination.Since measures affect different stages of a manufacturing process and often fall under

the responsibility of other departments(e.g.,quality control,quality assurance,or manufacturing),it

may not always ensure that the data obtained in the process,e.g.,from the original qualifications and

validations,process controls and ongoing environmental monitoring,are linked with each other.This

also applies to corrective and preventive actions that are often taken as a result of deviations and trend

analyses but are neither integrated into a strategy for a holistic view nor is there a linkage of all critical

control points and the evaluation of the effectiveness of all controls(design,procedures,technology,

and organization).However,a holistic view is proposed in the draft revision of Annex 1 version 12

(2020)for particulates,microbial,and pyrogen contamination.

制造商应设计其生产设施、设备和工艺，并实施质量风险管理 (QRM), 以确保适当的污

染控制，以尽量减少或检测污染。由于措施会影响到生产过程的不同阶段，而且往往由其

他部门负责(如QC、QA 或生产),因此可能并不总是能确保在这个过程中获得的数据，

如来自原始资格和验证、过程控制和持续环境监测的数据是相互联系的。这也适用于通常

是由于偏差和趋势分析而采取的CAPA, 但既没有被整合到整体策略中，也没有将所有关键

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标签： #指南 #中英文 #污染控制策略指南

摘要：

1FoundationFosteringharmonisationofGMP/GDPregulationsHowtoDevelopandDocumentaContaminationControlStrategy如何制定和编制污染控制策略-ECATaskForceonContaminationControlStrategy--ECA污染控制策略工作小组-3FoundationFosteringharmonisationofGMP/GDPregulations目录1.Background背景介绍.......................................................

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