Quality Assurance

When quality is your most important ingredient, you need to be sure your compounding Pharmacy is taking extra measures necessary to ensure the best products available. Some of Prescription Specialties quality assurance procedures include:
  • Daily temperature and humidity monitoring and documentation
  • Daily refrigerator monitoring and calibration
  • Daily calibration of analytical balances
  • Chemical weight verified by printout
  • Calibration of pH meter before each use on every compounded product
  • Ongoing training, testing and evaluation of aseptic personnel
  • Daily random sterility and pyrogen testing of products
  • Random endotoxin testing of product by independent laboratory
  • Scheduled certification of sterile environment
  • Independent lab testing of air and surface samples for the Cleanrooms
  • Compliance with USP Cleanroom Guidelines for High Risk Compounding
  • Continuous cleaning of compounding environments with alternating cleaning solutions
  • Compounding software with backup for continuous record keeping of:
    A. Formula
    B. Procedure/technique
    C. Lot numbers
    D. Prescription numbers
    E. Expiration dates
     
  • USP & NF Chemicals obtained from FDA approved suppliers.
  • Regulated storage of raw materials and end products.
  • Personnel trained and certified in procedures for each type of aseptic event.
  • Personnel dedicated to policies and procedures to ensure a quality product.