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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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