cGMP
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Regulatory Support
current Good Manufacturing Practice
Strict compliance with cGMP and FDA Guidelines Guarantees Quality Products.
cGMP manufacturing facilities, procedures, and documentation are maintained in accordance with current Good Manufacturing Practice as described in the United States Code of Federal Regulations.
Production Control Systems
- QA Controlled Documentation System
- Raw Materials Handling System (Receiving, testing, labeling and release)
- Environmental monitoring of the clean room
- Microbiological monitoring of the water systems
- Specific task training
- In Process control testing, verification of critical steps (i.e., Ninhydrin, LC-MS and HPLC)
Regulatory Inspections
- Aug 2007 FDA Inspection - no 483
- Aug 2005 FDA Inspection - no 483
- Jun 2004 FDA Inspection - no 483
- Oct 2002 State of California - Drug manufacturing License