Quality Risk Management as a Tool for Improving Compliance and Efficiency

Abstract

  Pharmaceutical manufacturing is undergoing radical changes in response to challenges being faced by the industry. Science-based tools and Quality Risk Management (QRM) are increasingly being used to improve the efficiency of manufacturing operations. With the support of regulatory agencies, the industry is investing in developing the knowledge base of manufacturing and establishing the design space. There is a strong business case for the use of QRM throughout the product lifecycle. Use of QRM tools such as Risk Ranking & Filtering and Failure Mode Effect Analysis is discussed. A case study discussing the use of QRM to optimize the preventive maintenance program in the Quality Control laboratory is presented.