IS IT NECCESARY TO PERFORM CLEANING VALIDATION FOR ALL PRODUCTS WE HAVE MORE THE 60 COMBINATIONS IN OUR PLANT SO IS IT POSSIBLE TO VALIDATE ALL THE PRODUCTS OR PL SUGGEST ME FROM WHERE WE CAN START. IF U PROVIDE ME SOME PROTOCOL THEM I SHAL BE VERY THANKFUL TO U MY MAIL ID IS ( simran2.swarn@gmail.com)
in case of plate prerparation for area monitoring is it necessay to precubate the paltes before use for 72 hrs we are using it on the same day of preparation is it right way of it is official to incubate the plates becaz in ip it is not mentioned if u have studiet it pl give me the reference
thanks
[quote=gagandeep kaur]IS IT NECCESARY TO PERFORM CLEANING VALIDATION FOR ALL PRODUCTS WE HAVE MORE THE 60 COMBINATIONS IN OUR PLANT SO IS IT POSSIBLE TO VALIDATE ALL THE PRODUCTS OR PL SUGGEST ME FROM WHERE WE CAN START. IF U PROVIDE ME SOME PROTOCOL THEM I SHAL BE VERY THANKFUL TO U MY MAIL ID IS ( simran2.swarn@gmail.com)
in case of plate prerparation for area monitoring is it necessay to precubate the paltes before use for 72 hrs we are using it on the same day of preparation is it right way of it is official to incubate the plates becaz in ip it is not mentioned if u have studiet it pl give me the reference
thanks[/quote]
Dear Gangadeep Kaur,
It is not necessary to perform cleaning validation for all products you have. It is only taking a huge burden. You can use the bracekting, matrixing approach and select worst case products within each group. The validation of the worst case product is OK. For selecting worst case, following things should be considered, the potency of the drug, solubility of the drug, minimum allowable residue and toxicity data. Based on these you can select the products for cleaning validation.
Hope u got ur answer,
For more details you can e-mail me personally at prawan_d@yahoo.com