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Pharmaceutical Quality Control: Ensuring Drug Safety, Efficacy, and Regulatory Compliance in Modern Medicine
Pharmaceutical quality control (QC) refers to the set of processes and testing protocols used to ensure that drug products meet predefined standards for identity, purity, potency, and safety. QC is a critical component of Good Manufacturing Practices (GMP) and regulatory compliance, designed to protect patients, maintain therapeutic efficacy, and prevent contamination or batch variability.
Pharmaceutical quality control encompasses raw material testing, in-process checks, finished product testing, stability studies, microbial assessments, and analytical validation using techniques such as HPLC, GC, spectroscopy, and dissolution testing.
QC laboratories employ stringent SOPs and calibrated equipment to verify chemical composition, content uniformity, and the absence of impurities or contaminants. Emerging technologies like automation, robotics, high-throughput screening, near-infrared spectroscopy, and AI-powered predictive analytics have enhanced efficiency, accuracy, and compliance in pharmaceutical quality control. QC is integral to clinical trial material validation, post-market surveillance, and ensuring batch-to-batch consistency. Regulatory agencies such as the FDA, EMA, and WHO provide guidelines…