REVIEW ON CURRENT GOOD MANUFACTURING PRACTICE: ENSURING QUALITY, SAFETY AND REGULATORY COMPLIANCE

Abstract

Current Good Manufacturing Practice (cGMP) represents a fundamental regulatory and quality framework for ensuring that pharmaceutical products are consistently manufactured and controlled according to predefined standards of quality, safety, efficacy, identity, strength, and purity. With increasing complexity in pharmaceutical manufacturing, globalization of supply chains, adoption of advanced technologies, and growing regulatory expectations, cGMP compliance has evolved from a predominantly inspection-oriented approach to a comprehensive, science- and risk-based pharmaceutical quality system. This review provides an overview of the principles, regulatory framework, and essential components of cGMP applicable to pharmaceutical manufacturing. Major areas discussed include the Pharmaceutical Quality System (PQS), personnel and training, premises and equipment, documentation and data integrity, material management, production and in -process controls, quality control, qualification and validation, deviation management, Corrective and Preventive Action (CAPA), change control, Quality Risk Management (QRM), Product Quality Review (PQR), supplier management, and self-inspection. The review also highlights the roles of major regulatory authorities and guidance frameworks, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), International Council for Harmonisation (ICH), and Central Drugs Standard Control Organization (CDSCO). Particular emphasis is placed on ICH Q9(R1) and ICH Q10 as important frameworks supporting risk-based decision-making, lifecycle management, continual improvement, and effective pharmaceutical quality systems. Emerging trends such as digitalization, continuous manufacturing, Process Analytical Technology (PAT), automation, artificial intelligence, and advanced data analytics are also considered. Effective implementation of cGMP should extend beyond procedural compliance to establish a sustainable quality culture capable of maintaining process control, preventing quality failures, protecting patients, and supporting continuous improvement throughout the pharmaceutical product lifecycle.