CQA stands for Critical Quality Attribute. In the context of pharmaceutical manufacturing, a CQA is a physical, chemical, biological, or microbiological property or characteristic of a drug product that is critical to ensuring the desired product quality. CQAs are essential parameters that must be controlled and maintained within appropriate limits, ranges, or distributions to meet the safety, efficacy, and quality requirements of the drug.
Examples of CQAs can vary depending on the specific drug product, but they may include potency, purity, content uniformity, dissolution rate, particle size, sterility, endotoxin levels, and stability, among others.
By focusing on Critical Quality Attributes, pharmaceutical manufacturers ensure that their products consistently meet the required quality standards, ensuring patient safety and therapeutic efficacy. The careful control and monitoring of CQAs are fundamental to the pharmaceutical industry’s commitment to delivering safe, effective, and high-quality medications to patients worldwide.
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