The injection liquid preparation and distribution automatic control system is to control the preparation of the concentrated solution into a concentrated solution in the concentrated preparation tank after the material enters the concentrated preparation tank; then the concentrated solution is transported to the dilute preparation tank, where the final volume is adjusted in the dilute preparation tank, and finally the finished solution is transported to Automatic control system for filling machines. The system should comply with the computerized system functional specifications in "GAMP5: ARisk-Based Approach to Compliant GxP Computerized Systems", and should be used in compliance with the provisions of "Good Manufacturing Practice for Pharmaceutical Products" (revised in 2010) to ensure that the system control function can meet process requirements and production All data in the process must be true, accurate, complete and traceable.
T/YYHG 0006-2023 history
2023T/YYHG 0006-2023 Code of practice for injection dosing and dispensing automatic control system