THE POTENTIAL OF HERBAL PRODUCTS MANUFACTURERS ALREADY COMPLIANT WITH THE FUNDAMENTAL MANUFACTURING PRACTICE TO THE ASEAN GOOD MANUFACTURING PRACTICE FOR HERBAL PRODUCTS STANDARD

Abstract

This research aimed to study and evaluate the potential of herbal products manufacturers who had already received the Fundamental Manufacturing Practice (FMP) Annex B certifications in accordance with the Drug Laws for complying with the Herbal Products Act B.E.2562 as well as to develop a regulatory system that will be appropriate at the present to monitor standards of herbal products manufacturers. It was found that the manufacturers had the potential or readiness to operate in compliance with all Chapters for 82.19% on average. The category with the highest average score was Chapter 4-Sanitation and Hygiene (100.00%), and the category with the lowest average score was Chapter 7-Quality Control at (55.41%). The developed system suitable in Thailand context for overseeing the standards of herbal product manufacturing factories considered grouping herbal product manufacturers according to the product risks or dangers along with the size of manufactures. In addition, a regulatory system was created to monitor standards of manufacturing herbal products in the country based on the potential, risks of the products, and size of manufacture.