QHACCP危害分析和关键控制点.pptVIP

PSH/SQQ Annex I.5 Hazard Analysis and Critical Control Points 危害分析和关键控制点 (HACCP) I.5: Hazard Analysis and Critical Control Points (HACCP) “A systematic, proactive, and preventive method for assuring product quality, reliability, and safety“ WHO: /medicines/library/qsm/trs908/trs908-7.pdf Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, WHO Technical Report Series No 908, Annex 7, WHO, Geneva, 2003 I.5:危害分析和关键控制点(HACCP) “A systematic, proactive, and preventive method for assuring product quality, reliability, and safety“ WHO: /medicines/library/qsm/trs908/trs908-7.pdf Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, WHO Technical Report Series No 908, Annex 7, WHO, Geneva, 2003 I.5: Hazard Analysis and Critical Control Points (HACCP) How to perform? 1. Conduct hazard analysis: identify preventive measures for  each step of the process 2. Determine critical control points (CCP’s) 3. Establish target levels and critical limit(s) 4. Establish system to monitor the CCP’s 5. Establish corrective actions to be taken, if CCP is out of  control 6. Establish verification procedures, that HACCP works  effectively 7. Establish documentation of all procedures and keep  records I.5:危害分析和关键控制点(HACCP) How to perform? 1. Conduct hazard analysis: identify preventive measures for  each step of the process 2. Determine critical control points (CCP’s) 3. Establish target levels and critical limit(s) 4. Establish system to monitor the CCP’s 5. Establish corrective actions to be taken, if CCP is out of  control 6. Establish verification procedures, that HACCP works  effectively 7. Establish documentation of all procedures and keep  records I.5: Hazard Analysis and Critical Control Points (HACCP) Potential Areas of Use(s) To identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination) Useful when proces