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12 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Quality Risk Management A well-written and well-implemented quality risk management plan is an integral and valuable element of an effective qual- ity system. During the development and manufacturing of pharmaceutical products, the bottom line is that things can and will go wrong. The purpose of a quality risk management plan is to help ensure continued compliance with regulatory requirements, such as good manufacturing practices or good laboratory practices, when events occur during manufacturing that potentially impact patient safety and product quality. International Council for Harmonization (ICH) Q9 states, "Two primary principles of quality risk management are: the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and, the level of effort, formality, and documen- tation of the quality risk management process should be commensurate with the level of risk" (1). In developing a plan, consider all aspects of the operation that impact the product. Managing a company's risk with a well-defined plan may help reduce the activities associated with poor quality and inefficiencies associated with the product and the process, such as a reduction in devia- tions/investigations, scrap or wasted materials, customer complaints, and product yield. The concept is to evaluate all aspects of the manufacturing process and identify areas of vulnerability. These vulnerabilities need to be assessed for their impact on the operation and the potential level of risk they pose. A well-written quality risk management plan is an ongoing process requir- ing rigorous documentation throughout the product lifecycle. It provides a solid rationale for how to improve efficiency and spend resources on the Susan J. Schniepp is executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. STOCKWERK-FOTODESIGN - STOCK.ADOBE.COM Quality Risk Management Plans Create Effective Quality Systems Susan J. Schniepp Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products.