Pharmaceutical Industry News
Learning Quality from Pharmaceuticals
Thursday, 01, April 2010
The discovery of contaminated blood thinner from China in commercial Heparin was a wake-up call for many in the pharmaceutical industry. The 2008 incident, which spanned nine countries and caused at least 21 deaths and 305 allergic reactions in the United States alone, illustrates the complex challenges pharmaceutical companies face in an increasingly competitive, global market.Because of the nature of the products they provide, pharmaceutical companies, which operate squarely in the category of process manufacturing, must produce products that are safe for the consumer and are of the utmost quality.
They must strive to produce products at the lowest cost, in the least amount of time—while still ensuring quality and compliance.Risk management tools must be integrated into every facet of the development and manufacturing process. Executives at these companies constantly look for ways to build efficiencies into the product cycle, while quality managers are tasked with making sure a host of strict procedures are followed to maintain product quality, safety and compliance with regulations from many countries.