Quality Assurance

1. Daily refrigerator monitoring and calibration, as well as temperature and humidity documentation
2. Daily calibration of analytical balances
3. Calibration of pH meter before each use on compounded products
4. Daily random sterility and pyrogen testing of products
5. Random endotoxin testing of product by independent laboratory
6. Scheduled certification of sterile environment
7. Independent lab testing of air and surface samples of Cleanrooms.
8. Continuous cleaning of compounding environments with alternating cleaning solutions
9. Compounding software with backup for continuous record keeping of:
   • Formulas
   • Procedures / Techniques
   • Lot Numbers
   • Prescription Numbers
   • Expiration Dates
10. USP & NF Chemicals obtained from FDA approved suppliers
11. Regulated storage of raw materials and end products
12. Personnel trained and certified in each type of aseptic procedure with continuous education and accountability
13. Internal tracking of quality related incidents

STERILE FORMULATIONS include products administered by injection (IV, IM, SQ, or via inhalation, intranasal or ophthalmic routes of administration. with over Sterile formulations have a number of special requirements including:

1. Sterility
2. Particulate Free
3. Pyrogen-Free
4. Stability
5. pH
6. Osmolarity Calculations