ping4santosh ★ India, 2020-04-28 11:54 (1451 d 20:50 ago) Posting: # 21353 Views: 2,832 |
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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 |