Simplifying Global Compliance
Norac, Inc. - April 3, 2009
Material Qualification activities performed to establish a new supplier of a critical raw material, Sodium Hydroxide (NaOH) in 2005, were deficient in that the initial lots used in the evaluation of the material were manufactured at a facility different from lots subsequently received and used in production. The firm performed full testing on the lots manufactured at a facility to assess the quality attributes and verify the supplier Certificate of Analysis. Subsequent lots manufactured at a facility were not always fully tested. There was no evaluation performed by the firm to demonstrate that the material produced at the manufacturing facility was comparable to the materials.
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