If you have planning for products into facility then calculate based on planned product but if you do not have the planning for next product and only facility is created for only single product then ADE/PDE value is your limit to verify your cleaning procedure is effective to remove previous product but as per guidelines dedicated facility does not need for validation for chemical sample only microbial sample is required for validation so that in this scenario you can follow the risk based approach and calculate MACO as per formula without entering next product details for all three criteria and lowest MACO is considered for limit calculation of swab & rinse. Further if any clarity please let me know.
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A complete view of cleaning validation for learning purpose
Yes it is complete demonstration
Hello sir , please provide this excel sheet as this will enhance my knwoledge by doing practice for future assignment
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Please calculate MACO for micronized dosage form like for MDI & DPI products
Ok I will explain in upcoming videos.
My question is how to calctlate MACO based on general 10ppm limit for 1st product of company since, we do not have any other product?
If you have planning for products into facility then calculate based on planned product but if you do not have the planning for next product and only facility is created for only single product then ADE/PDE value is your limit to verify your cleaning procedure is effective to remove previous product but as per guidelines dedicated facility does not need for validation for chemical sample only microbial sample is required for validation so that in this scenario you can follow the risk based approach and calculate MACO as per formula without entering next product details for all three criteria and lowest MACO is considered for limit calculation of swab & rinse.
Further if any clarity please let me know.
Nice information. Pl share excel sheet
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