Monitoring tablet press systems and powder blending 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, tablet press systems and powder blending 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 tablet press system, wherein said tablet press 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 tablet press system comprises a vessel.
4. The method of claim 1 , wherein the tablet press system comprises filling equipment.
5. The method of claim 1 , wherein the tablet press system comprises a time-stamped audit trail.
6. The method of claim 1 , wherein the tablet press systems comprises a bar code.
7. The method of claim 1 , wherein the tablet press systems comprises a user independent audit trail.
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 powder blending system, wherein said powder blending 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 powder blending system comprises a mixing tank.
12. The method of claim 10 , wherein said powder blending system comprises a clean-in-place (CIP) system.
13. The method of claim 10 , wherein said powder blending system comprises environmental controls.
14. The method of claim 10 , wherein said powder blending system comprises a modular cleanroom.
15. The method of claim 10 , wherein said powder blending system comprises a time-stamped audit trail.
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.