Certified Pharmaceutical GMP Professional Practice

Critical quality attributes are defined as what?

1. Management strategies for improving product sales

2. Physical or chemical properties required for quality, safety, and efficacy

3. Marketing tools for customer engagement

4. Employee qualifications for quality assurance roles

The correct answer is: Physical or chemical properties required for quality, safety, and efficacy

Critical quality attributes (CQAs) are essential characteristics of a pharmaceutical product that must be controlled and monitored to ensure its quality, safety, and efficacy. These attributes encompass both physical and chemical properties, which can include aspects like potency, purity, and stability. Understanding these attributes is crucial for manufacturers in the pharmaceutical industry because they directly impact the product's ability to meet regulatory requirements and provide the desired therapeutic effect. By defining CQAs, companies can design robust processes that ensure consistent product quality and effectively manage potential risks during production. The focus on CQAs aligns with Good Manufacturing Practices (GMP), which emphasize that quality should be built into the product from the very start and maintained throughout its lifecycle. This approach helps to ensure that the final product meets the necessary specifications and regulatory guidelines, ultimately protecting patient safety and maintaining public trust in pharmaceutical products.