Critical Quality Attribute (CQA)

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A Critical Quality Attribute (CQA) is a fundamental characteristic or property of a pharmaceutical product that significantly influences its safety, efficacy, quality, or performance. These attributes must be carefully controlled, monitored, and maintained within specified limits to ensure consistent product quality, adherence to regulatory standards, and customer satisfaction. Identifying and managing CQAs are pivotal processes in product development, manufacturing, and quality assurance, serving to mitigate risks and uphold the standards required by regulatory authorities.