17P Compounding Quality Assurance Examples
Potency and sterility: Wedgewood Pharmacy is confident in the potency and sterility of our preparations. We quarantine each batch of 17P until we receive results of testing for potency, sterility and endotoxins. Only after receiving those results from independent, FDA-registered laboratories do we release the vials of 17P for dispensing to you and your patients.
API Source: We obtain the active pharmaceutical ingredients used in the compounding of 17P only from FDA-registered re-packagers of pharmaceutical chemicals.
Wedgewood Pharmacy takes great pride in dispensing quality-assured, compounded preparations for our physicians and patients. For this reason, we have taken these extra steps and precautions to verify the potency and sterility of our compounded 17P since 2003. The list below provides more details on the characteristics of our quality assurance programs.
- Compliance with the United States Pharmacopoeia (USP) <797> guidelines for sterile compounding.
- Every batch of 17P quarantined until independent testing for potency, sterility and pyrogens is complete.
- Environmental monitoring program includes weekly lab-tests of air and surface samples in the clean room and daily monitoring and documentation of clean-room temperature and humidity.
- Air quality in the sterile compounding lab engineered for HEPA filtration to reduce particulates.
- Independent, routine certifications of clean rooms and laminar airflow hoods.
- Properly trained and evaluated staff in relation to aseptic manipulation skills, gowning technique and clean room use.
- Sterilization performed using filters (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean room.
- Post-filtration filter-integrity testing.
- Documented systems in place for handling complaints and investigating sterility failures and adverse events.
- Documented procedure in place for determining and conducting a recall, if necessary.
- Pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers.
- Certificates of Analysis available for all formula ingredients.
- Maintenance of both master formulas and lot-specific worksheets for all compounds.
- Prescription traceability back to the original formula log-sheet and the source of ingredients.
- Every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist.
- Potency of finished compounds verified through weight, volume and yield checks.
- pH testing on injections.