Compounding:

QUALITY CONTROL

• Daily laboratory temperature/humidity monitoring.
• Daily refrigerator/freezer monitoring/calibration.
• Bi-monthly validation of autoclave.
• Daily monitoring of incubator temperatures and samples.
• Daily/weekly calibration of analytical balances.
• Chemical weight verified by printout / software.
• Independent verification of raw materials (identity, purity).
• Two-point calibration of pH meter before each use.
• Ongoing training/testing/evaluation of aseptic personnel.
• Sterility testing of every aseptic product.
• Ongoing endotoxin testing program.
• Bi-annual certification of sterile cabinet.
• Scheduled verification of sterile environment.
• Continuous cleaning of compounding environments.
• Regulated storage of raw materials and end products.
• Policy and procedure for each type of aseptic event.
• Personnel/duties policies and procedures.
• Release of patient information policies and procedures.
• Compounding software with backup for continuous record keeping of:

 o Formula
 o Procedure/technique
 o Lot numbers
 o Prescription numbers
 o Expiration dates

This Includes Complete Recall and Reporting Ability on Any Ingredient of Any Product or Prescription at Any Time.

Selection of chemical grade: USP>NF>FCC>ASC>Stop, with distinctions made for route of administration and risk to benefit.

Our chemicals come from a FDA-inspected chemical supplier with the following quality control process:

• Upon receipt, all chemicals are visually inspected for product and container integrity, and placed into quarantine.
• The chemicals documentation is examined for completeness and accuracy.
• A sample is taken to the quality control lab where its physical properties are compared with the certificate of analysis, United States Pharmacopoeia, British Pharmacopoeia, or other reference documents.
• Chemical identity is verified by IR spectra, UV-VIS spectra, meltpoint, specific gravity and other chemical tests.
• If the chemical meets necessary criteria, the lot number is activated and released from quarantine.
• Prior to repackaging, the bulk container's barcode is scanned against the package labels to verify the information.
• After repackaging is complete, a random sample is pulled and identity is again confirmed.
• While filling an order, the chemical's barcode is scanned to insure the correct chemical, size and lot number has been pulled for the corresponding order.
• A final quality control audit is performed by again scanning all barcodes to validate order completeness.

Only one chemical supplier has this extensive quality-control program.  The chemicals are more expensive, but anything less is an unnecessary risk.

• Sterility Testing Includes (one or more of the following):

• Soybean casein digest medium (aerobic, fungal)
• Potato dextrose agar (increased fungal sensitivity)
• Fluid Thioglycollate medium (anaerobic)
• Two incubators plus room temperature

• Endotoxin Testing
• Potency Testing
• Bi-monthly surface and air quality testing of sterile isolator chamber
• Random cross check of potency and sterility by second laboratory
• Annual validation of procedures
• Semi-annual validation of personnel