Future developments in ICH - development and manufacture of drug substances
- In: D17 - Good Manufacturing Practices - Expectations for the coming decade (part I) on Thursday, 8 September 2011, 09:00-12:00
- At: Hyderabad (India) (2011)
- Type: Presentation
- By: THENNATI, Rajamannar (Sun Pharma Advanced Research Company Ltd, Vadodara, India)
Emphasis of current developments in ICH guidance is to provide approaches to establish a dependable commercial manufacturing process of producing a drug substance of defined quality. Improved scientific knowledge and with the advent of more sensitive analytical tools, it is becoming increasingly constructive to identify distinctive process.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.