Manufacturing of Cardioshen at Tasly Pharmaceutical follows strict quality control processes from raw material sourcing to production to supply chain managing. Here are some of the standards that take place at each stage of manufacturing:
• GAP (Good Agriculture Practice)
• CGEP (Current Good Extracting Practice)
• GMP (Good Manufacturing Practice)
• GLP (Good Laboratory Practice)
• GSP (Good Supply Practice)
GAP (Good Agriculture Practice): First drafted by European Medicines Agency (EMEA) in 1998, GAP is a controlling and processing standard for herbal plantation. It monitors the quality stability and safety of raw materials. GAP is a general standard, there are SOP standards for each drug ingredient. This is used in Tasly’s herbal medicine production as very first process.
GEP (Good Extracting Practice): The GEP process covers extraction, condensation, chromatography, extraction, crystallization, filtration, drying, etc. Making strict GEP rule is of extreme importance not only to the stability of products quality, but also to the improvement of its healing effect. The GEP standard takes consideration of Chinese medicine’s balancing properties and the digital quality standard during each production. This is used in the second process of Cardioshen production.
GMP (Good Manufacturing Practice): Since it came out in 1975, GMP has been used both as the basic principle for modern medical management, production, and the guarantee for the standardization of pharmaceutical enterprise. Herbal medicine production consists of many complex steps, all of which should be monitored strictly in order to avoid contamination and instability. GMP is an effective way of quality control and management of production, and it is used in the third process of Cardioshen production.
GLP (Good Laboratory Practice): GLP regulates experiment design, operation, data, reporting, supervision and the laboratory environment. It sets up rules for the organization, staff member, experimental apparatus and materials, as well as operational standard, plans, and files. This standard serves for guarantee of the reliability of accessing data through the strict regulation on all lab-testing processes.
GSP (Good Supply Practice): GSP is a crucial part of quality and safety control. It prevents the possibilities of accidents due to inferior quality. GSP was issued by China’s State Drug and Food Administration on April 30th, 2000, and was carried out on July 1st of the same year by Tasly.