Quality Assurance Procedures
1. Daily temperature/humidity monitoring.

2. Daily refrigerator monitoring/calibration.

3. Daily calibration of analytical balances.

4. Chemical weight verified by printout.

5. Independent verification of raw materials (identity, purity).

6. Calibration of pH meter before each use.

7. Ongoing training/testing/evaluation of aseptic personnel.

8. Random sterility testing of product.

9. Random endotoxin testing of product by independent laboratory.

10. Scheduled certification of sterile cabinet.

11. Scheduled verification of sterile environment.

12. Continuous cleaning of compounding environments.

13. Compounding software with backup for continuous record keeping of:
A. Formula
B. Procedure/technique
C. Lot numbers
D. Prescription numbers
E. Expiration dates

14. Regulated storage of raw materials and end products.

15. Policy and procedure for each type of aseptic event.

16. Drug Distributor policies and procedures.

17. Personnel/duties policies and procedures.

18. Release of patient information policies and procedures.