Certified Pharmaceutical GMP Professional Practice

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Study for the Certified Pharmaceutical GMP Professional exam. Use our comprehensive quiz with flashcards and multiple-choice questions, each with hints and explanations. Prepare thoroughly for your exam and enhance your career in pharmaceuticals!

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Which of the following is NOT a part of quality risk management practices?

  1. Risk assessment

  2. Financial optimization

  3. Risk control

  4. Risk review

The correct answer is: Financial optimization

Quality risk management (QRM) practices are critical in ensuring consistent product quality and safety in the pharmaceutical industry. These practices typically include four main components: risk assessment, risk control, and risk review. Risk assessment involves identifying potential risks and analyzing their potential impact on product quality. This is a systematic process to evaluate what could go wrong and how likely it is to happen. Risk control refers to the process of implementing measures to minimize or eliminate identified risks. This may involve engineering controls, procedural changes, or specific actions taken to mitigate the impact of the risks that have been assessed. Risk review is an ongoing process that involves monitoring and reassessing risks over time to ensure that risk management practices are effective and up to date. This allows organizations to respond to changes in the risk environment and make necessary adjustments to their risk management strategies. In contrast, financial optimization does not fall under the realm of quality risk management practices. While financial considerations can influence decisions in a pharmaceutical company, they do not directly relate to the systematic approaches used to identify and manage risks related to product quality and safety. Thus, it is properly identified as not being part of quality risk management practices.