The Research and Detecting Techniques of Pharmaceutical Process Control System of Traditional Chinese Medicine

Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

“…As such, the test results may not be able to fully and comprehensively reflect the quality of TCMs, and the approach is neither conducive in detecting changes in the production process and nor sensitive in identifying problems in time [42]. This is especially the case for traditional pharmaceutical process of TCMs that features the following: (1) low level of automation that affects the consistency of the operation and thus the product quality; (2) poor information integration capability that supports an automatic control system; (3) insufficient openness of the system that affects the interoperability and interchangeability of the bottom control appliances; and (4) poor maintainability and unreliable dependability of the appliance [43]. An operational procedure that strictly and accurately control the various control points (pretreatment, extraction, separation, concentration, dehydration and formulation) of the TCMs pharmaceutical process leading to a technological process control will have a direct impact on quality and effect of products.…”