Newsletter - March 17, 2016
Honest Troubles: Raw Material Risk Management in Focus
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 industries. Recently, the Honest Company had to publicly deal with a faulty raw material vendor leading to bad publicity and possibly loss of business. Read More..
Attempt to Sue Indian Drug Regulators in Indian Supreme Court Fails but Provides New fodder to Critiques
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 the Indian regulators are either incapable of enforcing the law or are corrupt. Read More..
Honest Troubles: Raw Material Risk Management in Focus
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 industries. Recently, the Honest Company had to publicly deal with a faulty raw material vendor leading to bad publicity and possibly loss of business. Read More..
Attempt to Sue Indian Drug Regulators in Indian Supreme Court Fails but Provides New fodder to Critiques
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 the Indian regulators are either incapable of enforcing the law or are corrupt. Read More..
