Compounds have both pharmacological effects and toxic effects. If a compound with high toxicity enters the human body and accumulates to a certain amount, it will act with the body fluids and organs, disrupt or destroy normal physiological functions of the body, cause temporary or permanent pathological changes in some organs and systems, and even be life-threatening.
Our client is one of the few listed pharmaceutical companies with a leading position in both manufacturing and distribution in China and ranked on the Global Fortune 500 list in 2021. This is an OSD intelligent plant renovation project planned for full close-loop transfer for the entire production process. The full closed-loop transfer system will integrate and interconnect the upstream and downstream equipment through the automatic weighing system and the automatic material transfer system. With the help of green and intelligent manufacturing, the goal of low contamination, low energy consumption, and low cost is realized.
AUSTAR has won the consulting service contract for the OSD intelligent plant renovation project. The service standard is NMPA GMP and US-FDA cGMP, and the scope of service includes VMP, SIA, process equipment qualification, and computerized system validation.
AUSTAR compliance consulting service team will be working closely with the client's project team to drive the implementation of the project with regulatory compliance, validation, and project management capabilities.