|
|
cGMP Lab
In 2007, we constructed a cGMP laboratory for the preparation of clinical trial materials and commercial API’s. In July of 2009 we successfully completed our first FDA pre-approval inspection (PAI) with no 483’s issued.
 Some features of the lab include:
- All air HEPA filtered
- Class 100,000 laboratory and access/egress rooms
- Class 10,000 packaging room
- All rooms differential pressure controlled
- Door magnetic interlocks on all access/egress rooms
- ~1000 sq ft
- 4 Bench Hoods, 1 Walk-in
- 2 gowning rooms
- Raw materials staging/glassware washing room
- Dedicated, segregated GMP warehouse area
|
|
|
