Docket Management
Docket: 00D-1418 - ICH; Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients; Availabilit
Comment Number: EC -15

Accepted - Volume 2

Comment Record
Commentor Mr. Venkatesh subramaniam Date/Time 2002-06-25 04:51:40
Organization Balfour Pharma ltd
Category Company

Comments for FDA General
1. General Comments Which date shall be considered as manufacturing date of an API 1. Date on which the Raw material has been charged into the reactor 2. Date on which the Final Step of API is over. 3. Date on which the API is tested for its critical quality attributes Please give your expert comments/suggestions on the above query Regards, Venkat

EC -15