Published Paper Details:

Good Manufacturing Practices (GMP) form the cornerstone of quality assurance in the pharmaceutical industry, ensuring that medicinal products are consistently produced and controlled according to established quality standards. Compliance with GMP is critical for safeguarding patient safety, maintaining product efficacy, and ensuring regulatory approval across global markets. However, the pharmaceutical industry faces increasing regulatory scrutiny due to evolving guidelines, frequent inspections, globalization of supply chains, and rising concerns related to data integrity and quality culture. Regulatory agencies worldwide continuously update GMP requirements to address technological advancements and emerging risks, which poses significant compliance challenges for pharmaceutical manufacturers, particularly in developing economies. This review provides a comprehensive overview of GMP principles and examines the regulatory frameworks governing pharmaceutical manufacturing. Major GMP requirements, common compliance challenges, and inspection-related deficiencies are discussed in detail. The impact of regulatory non-compliance on product quality, business sustainability, and public health is also highlighted. Furthermore, the review explores future perspectives, including digitalization, risk-based regulatory approaches, and the role of advanced technologies in strengthening GMP compliance. This article aims to provide a clear understanding of current GMP expectations and regulatory challenges, serving as a useful reference for academia, industry professionals, and regulatory stakeholders.