What does CQA stand for in pharmaceutical product development?

• A. Central Quality Assessment
• B. Critical Quality Attributes
• C. Critical Quick Access
• D. Controlled Quality Abstract

Answer: (B)

In pharmaceutical product development, CQA stands for Critical Quality Attributes. These are the properties of a drug substance or product that must be within predefined limits to ensure the final product’s quality, safety, and efficacy. CQAs are identified during development from the target product profile and risk assessments, and they drive how you design the formulation, the manufacturing process, and the control strategy. Examples include potency, dissolution, chemical purity and impurity levels, sterility, particle size, content uniformity, and pH. They are the basis for setting specifications and monitoring performance through production, and they connect with regulatory expectations by tying manufacturing parameters to actual product quality. The other options are not standard terms used in this context.