ABSTRACT
During 1997-1998, this project was carried out to evaluate the production process of local manufacturers and the quality of their products. The chosen manufacturers were those that had GMP certificates from Thai FDA. The chosen provincial hospitals were those whose criteria of Pharmaceutical Standard Performance under the Health Service System Development Project (HSSD), 1996 were met regarding the production area and clean room facility in producing sterile products. The expected outcome of the project was to provide information for proper manufacturing and to upgrade production to meet international standard requirements. The assessment of the manufacturing site was completed and all types of large-volume injection products from 4 manufacturers and 6 hospitals were collected and analyzed. It was found that 4 manufacturers met the requirements of GMP and HSSD on production process and quality control, only 3 of which having a perfect autoclaving validation. The cleaning process of reused glass containers in all 6 hospitals did not conform to standard criteria. In addition, lack of a sterilization process validation and no facilities in basic quality control for products such as particulate matter, pyrogen test or LAL test, etc. was also found. The quality of all collected products was analyzed and all conformed to the standard requirement. Finally, the author would like to suggest that the cleaning procedure of re-used glass containers and some production steps in the hospitals should be corrected, improved and verified. We also recommend unequiped hospitals to purchase these products from a qualified manufacturer.