Monitoring liquid mixing systems and water based systems in pharmaceutical manufacturing
Methods of monitoring pharmaceutical manufacturing processes are disclosed herein. The methods described herein provide an ability to control and monitor pharmaceutical manufacturing processes (for example, liquid mixing systems and water based systems) and can ensure data and product integrity and ultimately minimize overall manufacturing cost.
1. A method comprising,
a) monitoring data generated by a pharmaceutical liquid mixing system, wherein said liquid mixing system produces a drug product;
b) maintaining the data over time to provide a historical record;
c) analyzing the historical record to provide a quality assurance determination for said drug product;
d) taking corrective action to obviate a failure against said quality assurance determination.
2. The method of claim 1 , wherein the monitoring is continuous.
3. The method of claim 1 , wherein the liquid mixing system comprises a vessel.
4. The method of claim 1 , wherein the liquid mixing system comprises filling equipment.
5. The method of claim 1 , wherein the liquid mixing system comprises a vial inspection system.
6. The method of claim 1 , wherein the liquid mixing systems comprises a capping machine.
7. The method of claim 1 , wherein the liquid mixing systems comprises a process tank.
8. The method of claim 1 , wherein said historic record is maintained in a SQL database.
9. The method of claim 1 , wherein said quality assurance determination is based on a quality assurance protocol.
10. A method comprising,
a) monitoring data generated by a pharmaceutical water based system, wherein said water based system produces a drug product;
b) maintaining the data over time to provide a historic record;
c) analyzing the historic record to provide a quality assurance determination for said drug product;
d) taking corrective action to obviate a failure against said quality assurance determination.
11. The method of claim 10 , wherein said water based system comprises a chilled water/circulating system.
12. The method of claim 10 , wherein said water based system comprises a clean-in-place (CIP) system.
13. The method of claim 10 , wherein said water based system comprises D.I./R.O. water system.
14. The method of claim 10 , wherein said water based system comprises a vial washer.
15. The method of claim 10 , wherein said water based system comprises a water for injection (WFI) system.
16. The method of claim 10 , wherein said historic record is maintained in a SQL database.
17. The method of claim 10 , wherein said monitoring is continuous.
18. The method of claim 10 , wherein said quality assurance determination is based on a quality assurance protocol.
19. The method of claim 10 , wherein said quality assurance determination is performed by a quality control unit.