Laboratory quality assurance unit evaluation

Table II. Evaluation of Laboratory Quality Assurance Unit...

The quality assurance unit (QAU), the duties of which are described in Part 58.35, presents a special challenge to the FDA investigators. By evaluating QAU activities, the agency is able to assess the mechanisms by which the facihty management assures itself that the nonclinical laboratory... 

The lengths of the bars reflect the tested performance of the resins after one year in the indicated environments. The Composite Ratings are the ten year performances projected from the 1, 3, 6 and 12 month evaluations. All laminates were made according to ASTM Method C581 with a glass fiber content of 25 2%. To assure high quality, the ATLAC-based laminates were supplied by ICI United States. The other laminates were fabricated in the laboratory. 

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