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Quality Assurance Program Phone: 561-362-3358 - Fax: 561-362-3361 4411 North Dixie Hwy. Boca Raton, FL 33431 ©2008 Rejuvi Pharmaceuticals Home - Contact Form |
| Quality Assurance Program: 1. Daily temperatures/humidity monitoring. 2. Daily refrigerator monitoring/calibration. 3. Daily calibration of analytical balances. 4. Independent verification of raw materials (identity, purity) 5. Ongoing training/testing/evaluation of aseptic personnel. 6. Random sterility testing of product. 7. Random endotoxin testing of product by independent laboratory. 8. Scheduled certification of sterile environment. 9. Continuous thorough cleaning of compounding environments with disinfectants. 10. Compounding software with backup for continuous record keeping of: A) Formula B) Procedure/technique C) Lot Numbers D) Prescription Numbers E) Expiration dates 11. Regulated storage of raw materials and end products. 12. Policy and procedure for each type of aseptic event. 13. Drug distribution policies and procedures. 14. Personnel/duties policies and procedures. Close this window |