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

Authors: Deepika Rao, Aditya Sharma

ABSTRACT: Good Manufacturing Practices (GMP) are integral to ensuring the safety, quality, and efficacy of pharmaceutical products. Quality assurance (QA) within GMP frameworks provides systematic procedures to prevent errors, contamination, and deviations in drug manufacturing. This paper explores the principles, components, and implementation strategies of QA in GMP, emphasizing risk management, documentation, validation, and continuous improvement. Tables illustrate critical GMP areas, QA responsibilities, and compliance assessment. The paper also discusses challenges in GMP adherence and proposes strategies to strengthen QA practices. By integrating QA into GMP, manufacturers can maintain product integrity, meet regulatory standards, and safeguard patient health.

KEYWORDS: Good Manufacturing Practices, Quality Assurance, Pharmaceutical Manufacturing, Compliance, Validation, Risk Management.