How to Be Green in a CGMP-Regulated Environment
August 20th 2008The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.
Senator Brown Requests Information about Merck's Outsourcing Procedures
July 31st 2008Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.
FDA Launches Fellowship Program
July 24th 2008The US Food and Drug Administration seeks applicants for its new Commissioner’s Fellowship Program for scientists, engineers, and health professionals. The two-year program will help prepare the agency to replace a large number of FDA staff who are preparing to retire as well as meet future goals.
Bristol-Myers Squibb Upgrades Equipment for Clean Air Act Compliance
July 17th 2008Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million.
European Pharmacopeia Defines Policy for Potentially Genotoxic Impurities
July 10th 2008The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.
Enterprise-Level Change Control
July 9th 2008Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.
Nanoscale Technique Measures Surface Physical Properties of APIs
July 3rd 2008Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.