This video will walk you through various ways to establish MACO Value during cleaning validation, how to define swab limit and how one can identify worst case scenario
Sir, we are from pharma industry and your video has been really helpful in understanding the concept of cleaning validation. Can u please provide the reference documents or guidelines relevant to the data mentioned in this video as we are facing many queries on this topic during audits!
Sir me and my boss both are fan of you ... U r doing excellent job... Only one poin need to be consider that give reference of guidelines which make complete preparations of interview.😊😊😊
I have the same question, first you need to determine the worst case product by considering cleanability colors solubility... Then you have to calculate the worst case maco. Please feedback, if you find an answer.
Dear sir , Thank you for giving the valuable information . Here in conversion of µg/dm2 to ppm for swab , swab diluent volume taken as 10 ml .kindly explain how can i fix the volume of swab diluent.
Plz answer 1.What is safety limit for injectable. How we calculate safety factor for specific API. 2. What will be the batch size. Is it total bach size of product or only quantity of API in batch.
Fantastic interpretation Sir thank you.. Have a doubt on safety factor, for ex.how much to consider if the range of 10 to 1000 in case of topical, is it any number between 10 to 1000 suppose I select as 200 as safety factor or the maximum as 1000 how it is taken. Thankyou