Quality Assurance

The QUALITY ASSURANCE procedures utilized by Franck’s Pharmacy include:

1. Daily refrigerator monitoring and calibration, as well as temperature and humidity documentation
2. Daily calibration of analytical balances
3. Chemical weight verified by printout
4. Calibration of pH meter before each use on compounded products
5. Daily random sterility and pyrogen testing of products
6. In house testing using HPLC (High Pressure Liquid Chromatography) to test potency and stability of our products
7. Random endotoxin testing of product by independent laboratory
8. Scheduled certification of sterile environment
9. Independent lab testing of air and surface samples of Cleanrooms
10. Compliance with USP 797 Guidelines for High Risk Compounding, exceeding requirements with an ISO Class 6 Cleanroom
11. Compounding software with backup for continuous record keeping of:
    • Formulas
    • Procedures / Techniques
    • Lot Numbers
    • Prescription Numbers
    • Expiration Dates
12. USP & NF Chemicals obtained from FDA registered suppliers
13. Regulated storage of raw materials and end products
14. Personnel trained and certified in each type of aseptic procedure with continuous education and accountability
15. Internal tracking of quality related incidents

Sterile Formulations

STERILE FORMULATIONS include products administered by injection (IV, IM, SQ, ID, Pharmacists intrathecal, epidural) 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