O'Brien Pharmacy > Sterile Compounding > Quality Assurance Procedures > Quality Chemicals
 
     

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

1. Upon receipt, all chemicals are visually inspected for product and container integrity, and placed into quarantine.

2. The chemical's documentation is examined for completeness and accuracy.

3. 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.

4. Chemical identity is verified by IR spectra, UV-VIS spectra, meltpoint, specific gravity and other chemical tests.

5. If the chemical meets necessary criteria, the lot number is activated and released from quarantine.

6. Prior to repackaging, the bulk container's barcode is scanned against the package labels to verify the information.

7. After repackaging is complete, a random sample is pulled and identity is again confirmed.

8. 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.

9. 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 we believe anything less is an unnecessary and avoidable risk
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