Opportunities, challenges and benefits of using HACCP as a quality risk management tool in the pharmaceutical industry

Abstract

Effective quality risk management can facilitate better and more informed decisions, provide regulators with greater assurance of a company's ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight. The Hazard Analysis and Critical Control Points (HACCP) method is now a recognized and useful tool in the pharmaceutical industry to meet the primary principles of quality risk management. Global perspective, forward-looking view, open communication, integrated management, continuous process, shared product vision and teamwork are the principles, which provide a framework to accomplish effective risk management. The quality risk management process includes risk identification, risk analysis and risk evaluation. Control and reduction of the risk focuses on processes for mitigation or avoidance of quality risk when it exceeds an acceptable level. The quality risk management tools provide documented, transparent and reproducible methods to accomplish the steps of the quality risk management process. The HACCP methodology aims to prevent known hazards and reduce the risk that they will occur at specific points in the pharmaceutical manufacturing processes. It covers both the Good Manufacturing Practices (GMP) and the safety of the personnel engaged in the manufacturing processes. HACCP is the systematic method (comprised of seven principles) for the identification, assessment and control of safety hazards associated with physical, chemical and biological hazards. The problems associated with the implementation of HACCP may be overcome by training and education in the HACCP system for the personnel engaged in pharmaceutical industry. The HACCP system benefits all, the consumers, industry and the government as it focuses on prevention rather than relying mainly on end product testing. This scientific and systematic system is cost-effective and leads to reduced product loss and wastage, and assures the safety of pharmaceutical products. Copyright © 2009 John Wiley & Sons, Ltd.