Quality assurance

The facilities at Bova include;
  • 20 work stations including:
    • 14 work stations with powder extraction hoods;
    • 5 clean work stations;
    • 1 laminar airflow hood for the preparation of sterile medications.
  • A positive pressured laboratory dedicated to the preparation of sterile medications;
  • A negative pressured laboratory dedicated to the preparation of cytotoxic medications.

Bova uses pharmaceutical grade ingredients complying with USP/BP/JP specifications and manufacture in accordance with cGMP.

Bova source their raw materials from manufacturers from all over the world who are recognised for their high standards and quality pharmaceutical materials. The ingredients are then further independently tested for assay and heavy metals by Therapeutic Goods Administration (TGA) or APVMA licensed facilities.

 
Quality assurance procedures include;
  • Daily temperature and humidity monitoring and documentation;
  • Daily refrigerator monitoring and documentation;
  • Daily calibration of analytical balances;
  • Chemical weight verified by computer and pharmacist;
  • Daily calibration of pH meter;
  • Ongoing training, testing and evaluation of aseptic personnel;
  • Scheduled certification of sterile environment;
  • Monthly independent lab testing of air and surface samples for the cleanrooms;
  • Cleanrooms tested by NATA certified personnel, exceeding guidelines with a class 6 cleanroom;
  • Continuous cleaning of compounding environments by qualified and approved 3rd party technicians;
  • Compounding software with backup for continuous record keeping:
    • Formula 
    • Procedure/technique 
    • Lot numbers 
    • Prescription numbers 
    • Expiration dates
  • Chemicals obtained from approved TGA suppliers where possible;
  • Regulated storage of raw materials.

Download our Adverse Reaction document