The Development Process of Herbal Product Manufacturing Facility Standards in Khon Kaen Province According to the Herbal Product Act 2019

Abstract

Abstract

                   Objective: This research aimed to study the development process of herbal product manufacturing facility standards in Khon Kaen province, evaluate the development outcomes according to the Herbal Products Act B 2019, and develop an appropriate standard development model. Methods: This action research followed Kemmis and McTaggart's approach using the PAOR (Planning, Action, Observation, Reflection) cycle with 4 phases conducted at herbal product manufacturing facilities in Khon Kaen province between December 2024 and September 2025. Data were collected through in-depth interviews, focus group discussions, standard assessments using audit checklists, and satisfaction evaluation questionnaires.

                   Results: The study of the herbal product manufacturing facility standard development process in Khon Kaen province demonstrated significant success. The standard assessment scores (Audit Checklist) based on Good Manufacturing Practice guidelines for herbal products according to the Ministry of Public Health Notification on Criteria, Methods, and Conditions for Herbal Product Manufacturing B.E. 2562-2564 increased from 73.65% to 80.01%, representing a statistically significant improvement of 6.36% (p<.001). Satisfaction levels were at the highest level (92.20%) across all three dimensions: project implementation, personnel services, and information services. The key success factor was the transformation of government agencies' role from "evaluator" to "supporter," combined with participatory learning methods and collaborative networking, leading to the establishment of a sustainable learning community with a 5-year long-term development plan toward international standards. This resulted in the T.H.A.I Model comprising four components: TOGETHER (collaboration), HERBAL (herbal products), ADVANCEMENT (upgrading), and INITIATIVE (initiation).

                   Conclusion: The herbal product manufacturing facility standard development process in Khon Kaen province using the T.H.A.I Model was effective in upgrading manufacturing facility standards. The main success factors were stakeholder participation, network-based learning, expert support, and continuous development. This model can serve as a prototype for developing herbal product manufacturing facility standards in other areas.

Keywords: Manufacturing facility standards, Herbal products, ASEAN GMP, The Herbal Products Act B 2019