Critical quality attributes (CQA; German: kritische Qualitätsattribute /-merkmale) are physical, chemical, biological or microbiological properties of a drug that must be within certain limits or specifications in order to ensure the desired product quality. These attributes are closely linked to the quality, safety and efficacy of a drug, which means that it is crucial to carefully monitor them at all stages of product development, manufacture and storage.

Examples of critical quality attributes can be:

• Impurities (German translation: Verunreinigungen) associated with the manufacturing process
• Particle size distribution (translation into German: Partikelgrößenverteilung)
• Charge of particles
• pH value of the product
• Sterility (absence of living microorganisms)

Monitoring critical quality attributes is an essential component of quality management systems in the pharmaceutical industry. It ensures that each batch (German translation: Charge) of a product is safe for the consumer and effective for the intended use. The identification and evaluation of critical quality attributes begins in the early stages of product development and continues throughout the entire product life cycle, including up-scaling of manufacturing processes and marketing in order to ensure consistent quality and compliance with regulatory requirements.

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