QUALITY ASSURANCE

PROGRAM

ITEM

EXTERNAL AUDITS

AND INSPECTIONS

QUALITY ASSURANCE

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.

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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.