Day: March 17, 2016

Since the 2013 DOJ ruling against the Indian generic manufacturer, Ranbaxy, Indian manufacturers have been constantly in the news for all the wrong reasons. Although India is home to one of the World’s largest generic drug and API manufacturing industry with about 700 FDA-approved manufacturing facilities, the general impression is that Indian regulations are lax, and … Read more

The cardinal rule of raw material vendor management is to verify that vendor’s specification and documents related to the raw material being sourced. Errors in the quality of raw material could compromise the quality of the final product. In pharmaceutical GMP, raw material risk management is one of the core competencies. Not so in other … Read more