Articles by Ernest Parente - Pharmaceutical Technology

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Articles by Ernest Parente

Ernest Parente


Ernest Parente, PhD, is the associate director and laboratory head of quality control in Kansas City Industrial Affairs at sanofi-aventis US.

Acceptable Analytical Practices for Justification of Specifications
April 2, 2007

The concept of Acceptable Analytical Practices (AAPs) was developed by the Analytical Technical Group of the Pharmaceutical Research and Manufacturers of America to share information about how the pharmaceutical industry has implemented chemistry, manufacturing, and controls and quality guidances of the International Conference on Harmonization and worldwide regulatory authorities. The AAP process identifies and addresses critical issues in which guidance is lacking, ambiguous, or contradictory. AAPs were designed to provide a forum where one could learn from the experience of experts in pharmaceutical analysis and enhance the understanding of analytical practices that reflect good science and sound regulatory compliance. This article summarizes the discussion points from a meeting regarding the Justification of Specifications topic.

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