清洁验证 华海.pptxVIP

清洁验证 华海会计学第1页/共36页PRESENTATIONOverviewValidation ApproachMonitoring Revalidation第2页/共36页OverviewICH Q7: “Cleaning procedures should normally be validated. In general, cleaning validation should be directed to situations or process steps where contamination or carryover of materials poses the greatest risk to API quality. For example, in early production it may be unnecessary to validate equipment cleaning procedures where residues are removed by subsequent purification steps.”第3页/共36页Validation StudyPoints to considerProcess stepsContaminantsCleaning proceduresProcess EquipmentWorst CaseAcceptance CriteriaReagents SolutionsSamplingAnalytical MethodsMonitoring Revalidation第4页/共36页Validation StudyProcess Steps第5页/共36页Manufacturing Process API A Manufacturing Process API B Raw Materials Raw Materials 0 o 1Intermediate A/3 Intermediate B/3 0 o 1 Intermediate B/2 Intermediate A/2 0 1 o 2 Intermediate B/1 Intermediate A/1 1 o 2 2 Crude B Crude A 2 2 API A API B Validation StudyProcess Steps第6页/共36页REAGENTS (Raw Materials or previous intermediate) PRODUCT+ BYPRODUCTS (Intermediate or API)Validation StudyContaminats12Solvent used as cleaning agent: Is it part of process or not ?Note: If possible only Class 3 solvents should be used (ICH Q3C). Microbial Contamination: The API, also it is not sterile product, is used to produce sterile pharmaceutical products ?3第7页/共36页Validation StudyCleaning proceduresThe cleaning process is usually performed by solvents or solution with chemical-physical action (i.e. detergents) or with chemical action (i.e. oxidants; acids; bases; ..;etc.) In the API production plants:Often water cannot be used. The cleaning process is designed for a specific product第8页/共36页Validation StudyCleaning proceduresVarious products same equipment:Only one cleaning procedure for all the products Advantage: easy validation studies Disadvantages: it’s no common to use the same cleaning p