RESEARCH ON THE IMPLEMENTATION OF CURRENT GOOD MANUFACTURING PRACTICES IN ACTIVE TRADITIONAL MEDICINE INGREDIENTS INDUSTRIES IN INDONESIA

• Main Author: Dwi Tistiyanto, Purnama
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/73965
• Institution: Institut Teknologi Bandung

Traditional Medicine Businesses in Indonesia, including Traditional Medicine Small Businesses (TMSB), Traditional Medicine Micro Businesses (TMMB), Traditional Medicine Industries (TMI), and Active Traditional Medicine Ingredients Industries (ATMII), must adhere to Good Manufacturing Practices for Traditional Medicines (GMP for TM) in order to ensure the quality of their products. The Indonesian Food and Drug Authority (FDA) now implemented the current Good Manufacturing Practices (GMP) for Traditional Medicine (TM) standards, which are based on the PIC/S PE 009-015 standard and must be applied by Traditional Medicine Industry (TMI) and Active Traditional Medicine Ingredients Industry (ATMII) in Indonesia, along with an appendix relating to GMP for Active Traditional Medicine Ingredients (GMP for ATMI) for ATMII, which is based on the PIC/S PE 009-15 part II standard. This study aims to evaluate the GMP profile for ATMII implementation, specifically in 17 ATMII in Indonesia, and make recommendations to the Indonesian FDA on supervising and assisting ATMII. The method consists of developing a list of questions from 17 aspects of GMP for ATMI, including product development and technology transfer, being independently completed by 17 ATMII, followed by verification and assessment of compliance with GMP for ATMI implementation, with the conclusion that the categories were excellent, good, sufficient, or poor. Six ATMII (35.3%) were excellent, six (35.3%) good, three (17.6%) sufficient, and two (11.8%) poor. Evaluation of the results of the assessment of the implementation of the current GMP for ATMI that needs attention is the aspect of storage and distribution, outsourcing activities (factories including laboratories with contracts), and product development, whose fulfillment level was below 70% on average as well as in the aspect of personnel, aspects of quality control, and aspects of validation whose average fulfillment level was still below 80%, These elements were crucial because they substantially affect the quality's consistency.