Tag: Sterile Manufacturing

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fda-warning-letter-analysis

FDA Warning Letter Analysis: Catalent Indiana, LLC

This FDA Warning Letter analysis examines how weak investigations, ineffective contamination control strategies, and batch-release-driven decision making allowed contamination risks...
Featured graphic comparing terminal sterilization and aseptic processing in GMP manufacturing, with laboratory autoclave and sterile bottles.

Terminal Sterilization vs Aseptic Processing: Key Differences

Terminal sterilization vs aseptic processing explained. Compare sterility assurance levels, risks, validation expectations, and GMP regulatory guidance....
Media Fills In Sterile Manufacturing: Aseptic Process Simulation - Featured Image of Article

Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing

Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....

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