VALIDATION OF ASEPTIC PROCESSING IN STERILITY PHARMACEUTICAL MANUFACTURING FACILITY AS PER ICH GUIDELINES

Authors

  • Ramesh Chittudi, Raghava.D, Nageswara rao.K, Naga sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Aseptic Processing, Sterile Manufacturing, ICH Guidelines, Process Validation, Quality Risk Management, Regulatory ComplianceI

Abstract

Aseptic processing plays a critical role in sterile pharmaceutical manufacturing to ensure product safety and compliance with global regulatory standards. With increasing regulatory  scrutiny, especially from bodies such as the International

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Published

2025-10-07