Improvement And Optimization Of Workshops, Facilities And Process Flow Design During The GMP Certification In Troche Of Traditional Medicine

State Food and Drug Administration (SFDA) ordained the deadline of the qaulity of troche of traditional Chinese medicine under the standard of Good manufacturing practice (GMP). Since Jan 1st 2008 all medical industries of troche of traditional Chinese medicine have been coincident with the standard of GMP.There are many different kinds of troches, and they have various technical flow which are different from completed industrialized preparartion production and each has a unique trait when carrying out the standard. The purpose of carrying out this standard is to minimize the pollution in the production of the troches. Furthermore, When retrospecting the ideas and methods which must conform to under the standard of GMP in the last few years, there are some shortages such as the core technique which is not turly understood, wrong ideas about GMP, so we lost a lot of money, used the mode of preparation industries and carried out the standard of GMP without any effect.The study first analyzed the exsitent problems in troche of traditional Chinese medicine industries when carrying out GMP. According to the outstanding problems in carrying out the standard of GMP in troche of traditional Chinese medicine and unique traditional techniques, we optimized workshops and technical flow under precondition of ensuring the drugs' quality:As workshops and facilities improvements, we remained water mill floor, paved ceramic tile in the area with high moisture, intalled air conditioners in the areas which need low temperature and aerate in other areas to exhaust gas and moisture.The original workshop has been divided to two and high smoke and high temperature have been independented from the big workshop and concentrated to remove dust to improve technic.Secondly, we established the qaulity standard, added more control items in production and storation: parcel, water content and impurity.Through the studies we arrived some results as follows:First, compared with former arrangments of workshops ,the cost decreased 38%, the additional content of water in troche declined to 50% in the process of packing.Second, in technical flow, the average content of impurity reduced by 20% when it compared to the former and the productivity could reach 33 kg/h which increased to 144%.And the average rate of abnormal parcel was controlled about 8.64%. Moreover, the qaulity of troche have been greatly increased and the rate of finished product increases by 5.9 when compared with handwork. And the profit would increase 55 thousand RMB yearly.The study had shown that it would maintain the qaulity of troche of traditional Chinese medicine when carrying out the standard of GMP. Optimizations in technical flow of production in troche of traditional Chinese medicine not only meet the standard of GMP and the practical production but also ensure product quality, decreasing cost and environmental protection.The study of improving workshops and optimizing technical flow of production had achieved the expected effect.