By Lorely Milá Cáceres, Rodolfo Valdés, Carlos A. Garcia, Andrés Tamayo, Sigifredo Padilla, and Mercedes Ortega
Volume 9, Issue 1 (Summer 2010)
An interesting situation occurred ten years ago in an industry where quality had been the critical factor in management decision-making. Quality was abruptly bumped to second place behind pricing, which started a global rush to find lower-cost suppliers and eventually resulted in massive outsourcing. During this evolution, the importance of quality systems for the pharmaceutical and biopharmaceutical community was recognized by regulatory agencies that began establishing risk management standards…
Citation: Milá Cáceres L et al. Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries. BioProcess J, 2010; 9(1): 26-37. http://dx.doi.org/10.12665/J91.Valdes
Posted online September 12, 2010