CAPA Assessment Report – High-Level Review of FDA 483 Observations
Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated…
EU Annex 1 compliance for superheated water steriliser – Part 1
"There should be routine checks on the equipment to ensure that nozzles (where the water is introduced) are not blocked…
Cycles for steam sterilisation and post-aseptic processing terminal heat treatment
Sterilization Process Advisor – Tool Overview and InstructionsThe Sterilization Process Advisor is a simple and interactive tool designed to help…
Q&A On Sterility Assurance
#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in…