Alliance Contract Pharma – FDA EIR, Dec 17, 2018

An FDA surveillance inspection of Alliance Contract Pharma, LLC, a contract pharmaceutical drug manufacturer in Harleysville, PA, was conducted from December 12 to 17, 2018. This inspection, carried out under the regulatory framework of CP 7356.002 Drug Manufacturing Inspections as part of the PY 19 Work Plan, did not result in an FDA Form 483, Inspectional Observations. However, three significant discussion items were raised regarding the firm's operational practices.

The main issues included incomplete investigation documentation, which lacked essential supporting materials such as screenshots, dates of actions, and clear authorization details, rendering the files less comprehensive. Additionally, analytical methods demonstrated insufficient accuracy and precision for the Limit of Quantitation (LOQ), with the LOQ not always determined by method precision, sometimes falling outside the assessed range, and occasionally exhibiting a signal-to-noise ratio below 10:1. Finally, there was inadequate documentation and review of changes or reprocessing in chromatographic work, as reasons for such alterations were not consistently recorded in laboratory notebooks or software, and a verifiable second-party review of these comments was absent.

Management, including President Mr. Steve Schweibenz and Vice President of Quality Assurance Mr. Shawn Connaghan, committed to addressing these observations to enhance the firm's documentation practices and analytical method robustness.