Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Dr. Meera Krishnan, Mr. Rohan Sharma

ABSTRACT: Quality assurance (QA) forms the backbone of the pharmaceutical manufacturing industry, providing a comprehensive framework to ensure that every medicine reaching the patient is safe, effective, and of the highest quality. Unlike quality control, which focuses on testing final products, QA covers the entire lifecycle of production—from raw material procurement and process validation to packaging and distribution. This paper explores the principles, practices, and importance of QA in pharmaceuticals, examining global standards, Indian regulatory frameworks, and industry-specific challenges. It also reviews key components of QA, such as Good Manufacturing Practices (GMP), documentation, and continuous monitoring, while highlighting innovations like digital quality systems and real-time analytics. Through critical analysis, this paper underscores how QA safeguards public health, ensures regulatory compliance, and strengthens trust in medicines worldwide.

KEYWORD: Quality Assurance, Pharmaceutical Manufacturing, GMP, Patient Safety, Regulatory Compliance, Risk Management, Drug Quality