Implementation of good distribution practice in a Thai pharmaceutical manufacturer

Abstract

Good distribution practice (GDP) has recently been adopted and practiced by the pharmaceutical industry in Thailand, complementing the supply chain perspective and fundamentally transforming the industry’s quality landscape. This study proposed a GDP implementation methodology that integrates project management and quality risk management (QRM) to effectively identify, manage, and mitigate distribution risks. The project management framework provides valuable tools and approaches for prioritizing operational gaps, managing expectations, and securing necessary resources, while QRM focuses on the risk aspects such as operation impact, reputation, and cost for manufacturers. The methodology was successfully applied to a pharmaceutical manufacturer to ensure product quality during storage and distribution and to prevent counterfeit products from infiltrating the supply chain. This study provides 4 insights into GDP implementations: (1) fostering a project management culture, (2) utilizing existing templates and tools, (3) implementing continuous compliance monitoring, and (4) embracing digital transformation through information technology systems. This implementation represents an opportunity to engage executives and extend the quality program beyond manufacturing into logistic activities.