Quality by Design and Risk Management Approach to Validation
The Quality by Design (QbD) and Risk Management Approach to Validation are two integral parts of the pharmaceutical industry. Quality by Design (QbD) is a systematic approach that focuses on product and process understanding and process control to ensure the quality of finished products (Arora et al., 2016). It is an approach that involves designing, developing, and optimizing products and production processes in order to meet product quality requirements. The QbD approach is a proactive approach that aims to prevent quality problems from occurring. The Risk Management Approach to Validation is a risk-based approach that focuses on the identification of critical manufacturing parameters and process variables that are critical to product quality. The goal of this approach is to identify and address potential risks that could adversely affect the quality of the product (Razmara et al., 2017). This approach requires the evaluation of the. Cont…
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