In The News

Temple University School of Pharmacy Regulatory Affairs Quality Assurance Graduate Program is celebrating 50 years! It is the nation’s longest-running program for our unique environment. KENX has aligned with Temple’s RA and QA graduate program to support research and scholarship funding. Dean Peter Doukas, PhD... Read More...

A VMP describes aspects for qualifying your facility, including written procedures for equipment and systems validation and maintaining the qualified state. This process document will give you a roadmap. Read More…

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Cleaning validation is challenging and TOC is an effective analytical method to accomplish right-first-time validation. The following article is a must-read for all those cleaning validation enthusiasts interested in ensuring the best selection of a TOC analyzer. Read More…

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On April 4, 2017 the FDA issued a letter to a major pharmaceutical company that had responded to Warning Letter on cGMP violations. The letter contains information regarding data integrity issues stating: “Your quality system does not adequately ensure the accuracy and integrity of data... Read More...