GRAM Laboratories, Inc.
1. The quality assurance program at GRAM Laboratories is independent and comprehensive.
2. One-hundred percent of reported data is audited.
3. A comprehensive change control system provides
assurance of quality.
4. Calibration and/or qualification of all equipment and instruments are performed on a regular basis.
5. All laboratory personnel are trained in the operation of analytical instrumentation and performance of analytical methods.
6. Internal audits of the laboratory operation is done on a regular basis.
1. Several successful audits by clients.
2. In the last twenty years, ten FDA inspections, both
PAI and cGMP, with several of them without
any FDA 483 observations.