Volume-2 ,Issue-1, January-2026

Drug safety, effectiveness, and therapeutic dependability are all significantly influenced by pharmaceutical quality. Pharmaceutical quality management relies heavily on Quality Control (QC) and Quality Assurance (QA), which guarantee that raw materials, in-process intermediates, and final products continuously satisfy predetermined requirements. While QA covers the larger framework of systems, documentation, and compliance throughout the product lifecycle, QC concentrates on analytical testing and process monitoring. The notion of pharmaceutical quality, essential quality characteristics, and the function of QC and QA in many dosage forms and production phases are all covered in this paper. Regulatory frameworks, validation procedures, quality management difficulties, and new trends like Quality by Design (QbD), automation, digitalization, artificial intelligence, and continuous production are also highlighted. To improve product consistency, patient safety, and regulatory compliance, it is crucial to integrate contemporary tools and proactive quality initiatives with a focus on a lifecycle and risk-based approach.

Keyword: Pharmaceutical quality, Quality control, Quality assurance, Good manufacturing practices, Quality by Design, Continuous manufacturing, Regulatory compliance