Preservative efficacy test - E coli [Regulatives / Guidelines]
Hello All,
For preservative testing of parenterals, Ph. Eur. specifies, but does not make E. coli mandatory for sterile multi-dose parenterals. However, USP makes it mandatory for E. coli testing. Can someone help me to understand the reason behind it? Can we request a waiver from E.coli testing from US and if yes, what should be our argument?
Thanks a lot in advance!
Cheers,
SKM
For preservative testing of parenterals, Ph. Eur. specifies, but does not make E. coli mandatory for sterile multi-dose parenterals. However, USP makes it mandatory for E. coli testing. Can someone help me to understand the reason behind it? Can we request a waiver from E.coli testing from US and if yes, what should be our argument?
Thanks a lot in advance!
Cheers,
SKM