- Sterility testing of every high-risk aseptic preparation.
- Sterility tests retained for 1 year.
- Continuous laboratory temperature/humidity monitoring with email/text alerts.
- Continuous refrigerator/freezer monitoring/calibration with email/text alerts.
- 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.
- 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:
- Lot numbers
- Prescription numbers
- Expiration dates
This Includes Complete Recall and Reporting Ability on Any Ingredient of Any Product or Prescription at Any Time.
Quality compounding begins with quality chemicals that meet or exceed stringent pharmaceutical specifications. Inexpensive chemicals that are past or near expiration, with no independent verification, are available but unacceptable to O’Brien Pharmacy. And a Certificate of Analysis is on file for ALL of our chemicals.
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 chemical’s 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