At Blenheim Pharmacal, quality,
control
and integrity are the foundation on which our business is built. The
safety and wellbeing of our ultimate customer... the consumer, is
BPI's highest priority.
Quality
in Control
- Full compliance to
FDA
current good manufacturing practices (cGMP)
- Preparation for
future full compliance with
incoming Drug Pedigree guidelines.*
- DEA
Registered
- Board of Pharmacy
licensed
- Controlled by
approved Standard Operating Procedures
- Full equipment
validation
- A dedicated Quality
Assurance and Quality Control team
- Long-standing and
excellent relationship with
FDA,
DEA
and state regulatory agencies
- Meticulous change and
process control
- Rigorous label
control and processing
- Full product and
facility security, monitored 24 hours a day
- Prescription Drug
Marketing Act (PDMA)_Link
All BPI's operations are
performed in accordance with the
Food and Drug Administration's
21 Code of Federal Regulations Parts 210 and 211 and
FDA Docket No. 92D-0345 "Draft
Guideline on Repackaging of Solid Oral Dosage Form Drug Products"
and adhere to FDA's
Current Good Manufacturing Practices (cGMP).
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