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Setting Specifications for Drug Products

  • Abbie Gentry
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

Developing specifications for global drug products requires a multi-faceted approach that begins with an understanding of the attributes of the formulation, and how to assess those attributes that are critical to the safety, efficacy and quality of the final drug product. An understanding of global regulatory requirements, as well as requirements that are specific to significant markets adds additional complexity. In addition to developing specifications for the drug product to meet through shelf-life, many drug products require the development of release specifications which require an understanding of stability trends and batch-to-batch variability. This session will include several examples of how these approaches were used.

Keywords

Drug Product Process Capability Acceptance Criterion Active Pharmaceutical Ingredient Total Aerobic Count 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.McNeil Consumer HealthcareFort WashingtonUSA

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