Doc. 45 CLEANING VALIDATION, MONITORING AND VERIFICATION - english version

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download.PDF.EHEDG.DOC_45_E_2021
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EHEDG 2021
Seiten /pages: 48

This guideline provides recommendations for establishing site specific cleaning validation, monitoring, and verification programs in a food manufacturing environment. It explains the overall concept and provides templates and practical examples that can be used in order to establish validation, monitoring and verification programmes.

Contents:

Summary 
Introduction  
Objectives and scope  
Normative References  
Definition of Terms  
General Considerations 
Validation, monitoring and verification  
“V”-model for new equipment installations and facilities  
Cleaning Validation and HACCP  
Legacy Equipment Installations  
Cleaning Validation Master Plan  
The validation protocol  
Number of repeats  
Selection of worst case conditions  
Identification of relevant contaminants 
Sampling and testing  
Execution of the Cleaning Validation  
Cleaning Validation Report  
Revalidation  
Monitoring  
Verification  
Supplemental Reading  
EHEDG Guidelines 
International and National Guidance  
International Audit Standards 
Annex A: Key Learning Points 
Annex B: ATP threshold levels Establishing 
Annex C: Examples of Acceptance Criteria 
Annex D: Example of CIP Validation Protocol and Record 
Annex E: Example of OPC Validation Protocol and Record 
Annex F: Example of COP Validation Protocol and Record 

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