Critical Quality Attribute (CQA) in 2026: Expert Guide to Ensure Drug Quality
Critical Quality Attributes (CQAs) are crucial in pharmaceutical manufacturing because they directly affect drug safety, efficacy, and consistency. Regulatory agencies including the FDA and ICH require thorough CQA assessment to minimize risks and ensure high-quality medicines. By following best practices like early identification, risk assessment, and continuous monitoring, manufacturers can maintain robust production processes. Implementing modern strategies such as Quality by Design and integrating CQAs with quality assurance systems ensures compliance and safeguards patient health throughout the product lifecycle