Sterile Products – Quality Control

Quality Assurance

  1. Daily temperature and humidity monitoring and documentation.
  2. Daily refrigerator/freezer monitoring and calibration.
  3. Daily calibration of analytical balances.
  4. Chemical weight verified by printout.
  5. Calibration of pH meter before use on every compounded prescription (injectables, ophthalmic preparations, and other compounds).
  6. Ongoing training, testing and evaluation of aseptic personnel. Pharmacists and technicians training and validation in aseptic techniques, cleanroom regulations, and USP guidelines.
  7. Daily random sterility and pyrogen testing of products.
  8. Random endotoxin testing of product by independent laboratory.
  9. Bi-annual independent certification of Class 10,000 cleanroom and laminar airflow.
  10. In-house sterility validation of each autoclaved load and each filtration batch.
  11. Potency validation of finished compounds through weight, volume and yield checks in accordance with USP guidelines.
  12. Independent lab testing of air and surface samples for the cleanroom.
  13. Compliance with USP cleanroom guidelines for high risk compounds.
  14. Continuous cleaning of compounding environments with alternating cleaning solutions.
  15. Compounding software with backup for continuous record keeping for:
    • formula
    • procedure/technique
    • lot numbers
    • prescription numbers
    • expiration dates
  16. USP & NF chemicals obtained from FDA approved suppliers.
  17. Regulated storage of raw materials and end products.
  18. Personnel trained and certified in compounding procedures.
  19. Personnel dedicated to policies and procedures to ensure quality.

Quality Assessment
Check chemical description for:

  1. particle size and shape
  2. color
  3. quantity

Quality Control
A. Prepare one compound at a time in designated area.
B. Weighing Chemicals

  1. Check weights before and after weighing.
  2. Check chemicals being weighed.
  3. Check protocols for compound preparation.
    • Retrieve formula sheet.
    • Check each chemical as you retrieve it.
    • Place all chemicals to be weighted on left of balance.
    • Place all chemicals already weighted to right of balance.
    • Check chemical name as it is weighted.
    • Check chemical as it is recorded on compounding log.
    • Print out chemical weight and check chemical name, lot number and expiration date.
    • When compound is finished, check chemical name as it is returned to stock area.