A Review of NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients – Findings and Best Practices

31. March 2017

Investigation on the Combined Effect of Hydroxypropyl Beta-Cyclodextrin (HPβCD) and Polysorbate in Monoclonal Antibody Formulation

Development of a stability indicating high-performance liquid chromatography method for determination of cenobamate: study of basic degradation kinetics

Development and application of control concepts for twin-screw wet granulation in the ConsiGma-25: Part 2 granule size

ABSTRACT: CTwo year look back at the status of the NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients. What are we seeing as a certification body including best practices around risk assessment, quality improvement, the role of management and feedback from companies that have worked to meet the requirements of this GMP standard?