CAC_GL 69-2008 食品安全控制措施的验证准则
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B24DF65998C34EEFB0077CD667D435B1 |
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文件大小(MB)： |
0.13 |
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页数： |
16 |
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日期： |
2009-10-31 |
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文本摘录（文本识别可能有误，但文件阅览显示及打印正常，pdf文件可进行文字搜索定位）：
CAC/GL 69 - 2008 Page 1 of 16,GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES,CAC/GL 69 - 2008,I. INTRODUCTION,The control of hazards potentially associated with foods typically involves the application of control measures in the food chain, from primary production, through processing, to consumption. In the current environment of systems-based food safety controls that provide flexibility with the selection of control measures, validation of these control measures acquires increased importance. It is through the validation process that one demonstrates that the selected control measures are actually capable, on a consistent basis, of achieving the intended level of hazard control.,It is important to make a clear distinction between the role of industry1 and the role of the competent authority in validating control measures. Industry is responsible for validation of control measures, while the competent authority ensures that industry has effective systems for validation and that control measures are appropriately validated. Governments may provide guidance to industry on how to conduct validation studies and how validated control measures may be implemented. Governments or international organizations may also conduct validation studies in support of risk management decisions or provide information on control measures considered to be validated, especially where the resources are not available to conduct such studies (e.g. small and less-developed businesses).,These guidelines present information on the concept and nature of validation, tasks prior to validation, the validation process, and the need for re-validation. These guidelines also address the difference between validation, monitoring and verification. Annex I provides examples of validation scenarios which are for purpose of illustration only and which do not represent actual validation of control measures and which do not have global application.,II. SCOPE,These guidelines apply to validation of control measures at any stage of the food chain2. These guidelines are intended as guidance to industry and governments on the validation of individual control measures, a limited combination of control measures, or sets of control measure combinations forming a food safety control system (e.g. HACCP, GHP).,The tools, techniques, and statistical principles that would be used to validate specific food safety control measures are beyond the scope of the current document. Advice on specific applications should be acquired from scientific organizations, competent authorities, process control experts or related sources of scientific expertise that can provide the specific principles and best practices upon which the validation of a specific control measure should be based.,1 For the purposes of this document, it is understood that industry includes all relevant sectors associated with the production, storage and handling of food, from primary production through retail and food service level (adapted from Working Principles for Risk Analysis for Application in the Framework of Codex Alimentarius and taken from Principles and Guidelines for the Conduct of Microbiological Risk Management (CAC/GL 63-2007).,2 The focus of this document is the validation of elements of a food safety control system; however, the recommendations in this document also may be applied in the validation of other food hygiene measures.,CAC/GL 69 - 2008 Page 2 of 16,III. DEFINITIONS3,Control Measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.4,Food Safety Control System: The combination of control measures that, when taken as whole, ensures that food is safe for its intended use.,Monitoring: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.5,Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.6,Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.7,IV. CONCEPT AND NATURE OF VALIDATION,Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether control measures are capable of achieving their specified purpose in terms of hazard control. Validation involves measuring performance against a desired food safety outcome or target, in respect of a required l……
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