Judge Wolin rendered a decision that is consistent with the concept of building quality into the product. He relied heavily on the opinions of the experts presented by both sides. The judge's decision instructs both the government and the industry in the doctrines and concepts that must be considered when evaluating difficult scientific issues affecting the quality of drug products. This is most evident in the discussions of procedures for the investigation of out of specification results and the factors one must address when considering the release of drug products.

This decision concludes that end product test results represent only one of many indications of quality and these results alone represent an insufficient quality release specification.


1. 812 Federal Supplement 458 (D.N.J. 1993)

3. R.E. Masden, PDA J. Pharm. Sei. Technol, 48, 176-179 (1994)

Part Three: Specific Methods and Applications

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