Mainstreaming Quality Management Systems in Manufacturing of Traditional Medicines in Bhutan - Commentary

Abstract

This article describes the integration of Quality Management Systems and Good Manufacturing Practices in the production of traditional medicines at the Menjong Sorig Pharmaceuticals Corporation Limited, a state-owned traditional medicine manufacturer in Bhutan. Rooted in Sowa Rigpa principles, the organization has adopted modern pharmaceutical standards to ensure the safety, efficacy, and quality of its products. Key components of Menjong Sorig’s Quality Management Systems include leadership commitment, risk-based preventive action, robust documentation, supplier qualification, personnel competency development, and stringent quality control. The alignment with ISO 9001:2015 standards and the principles of Good Manufacturing Practices underscores Menjong Sorig’s commitment to sustainable practices, from sourcing medicinal plants to ensuring compliance with regulatory requirements. Sustainable sourcing of medicinal plants is supported by good agricultural and collection practices and community-based initiatives. Stringent quality control measures, such as the use of High-Performance Thin Layer Chromatography, ensure that raw materials, intermediates, and finished products meet predefined quality standards. Menjong Sorig’s investment in personnel training and competency development reflects a commitment to continual improvement, with regular internal audits reinforcing compliance with global standards. Balancing traditional values with modern corporate expectations, Menjong Sorig has maintained stakeholder trust through transparent operations and adherence to regulatory requirements. This article highlights Menjong Sorig’s systematic approach to integrating traditional practices with modern pharmaceutical standards, setting a benchmark for quality in traditional medicine manufacturing. Menjong Sorig’s efforts exemplify a sustainable and innovative approach to preserving cultural heritage while ensuring the global relevance of traditional medicines.