Development of Scientifically Sound Control Strategy for Drug SubstanceThursday, 16 April 2015 at 11:45 Add to Calendar ▼2015-04-16 11:45:002015-04-16 12:45:00Europe/LondonDevelopment of Scientifically Sound Control Strategy for Drug SubstanceQbD in Pharma Development World Congress in ChandigarhChandigarhSELECTBIOenquiries@selectbiosciences.com In this talk risk based approach will be discussed for efficient development of the DS control strategy. This talk will cover the following points: Identification of Critical Quality Attributes of the drug substance,Understanding of formation and purge of the impurities, Identification and control limits of parameters impacting quality, Setting up appropriate specifications for SMs and intermediates to ensure quality,Verification of control strategy, Defining the scientifically sound control strategy. |