Abstract:
This study applied RFID tracking of the manufacturing process and tracing back of product for preventing API loss with phenobarbital tablets as a case study. GPO has produced narcotic drugs, and psychotropic substances complied with GMP, Narcotics Act, and Psychotropic Substances Act. It included designing RFID implementation, determining user requirement and functional specification, selecting suitable devices, evaluating significant parameters and verifying the designed system. The verified software was continuously tested in stages of site testing and was assessed the risk with FMEA tool, user’s satisfaction and the impact on the manufacturing process. The risk priority class of a plant which followed GMP shall be negligible generally. The result showed the risk priority class of RFID implementation for potential failure modes that cannot protect opening a material container or confuse with other materials during shipping between sections were reduced from minor class to negligible and RPN values were decreased up to 50%. Thus, the RFID has effectively supported throughout the manufacturing process, material management, tracking and tracing of product and process, and risk reduction. The finding also suggests in the process development, supports the quality system, and builds the competitive strength in the pharmaceutical market.
