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12 BioPharm International eBook December 2019 Quality Risk Management Plans Create Effective Quality Systems Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products. A well-written and well-implemented qual- ity risk management plan is an integral and valuable element of an effective qual- ity system. During the development and manufacturing of pharmaceutical prod- ucts, 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 ulti- mately link to the protection of the patient; and, the level of effort, formality, and documentation of the quality risk management process should be commen- surate with the level of risk" (1). In developing a compa ny 's pla n, consider a ll aspects of the operation that impact the product. Managing your 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 devi- ations/investigations, scrap or wasted materials, cus- tomer complaints, and product yield. Stockwerk-Fotodesign - SUSAN J. SCHNIEPP is executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. SUSAN J. SCHNIEPP Regulatory Sourcebook Quality Risk Management

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