Category «Regulatory»

ICH Q11 Q and A Document

It’s only fair to share… ICH Q11   Q and A Document The topic of starting materials has been a vexed topic for some period. Indeed concerns relating to lack of clarity and issues pertaining to practical implementation led the EMA in Sept 2014 to publish a reflection paper—Reflection on the requirements for selection and …

QbD Presentations

It’s only fair to share… Qbd by Anthony Melvin Crasto for API from Anthony Melvin Crasto Ph.D   Organizational Initiatives Towards Developing Greener Processes for Generic Active Pharmaceutical Ingredients – Dr. Vilas H. Dahanukar, Chief Scientist-Process R&D, Integerated Product Development Organization, Dr. Reddy’s Laboratories Ltd., India presented at 4th Industrial Green Chemistry World Convention & …