Photostability Testing of New Drug Substancesdrug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
Photostability Testing of New Drug Substances and ProductsPhotostability Testing of New Drug Substances and Products in pharmaceutical industry
QUALITY RISK MANAGEMENT ICH Q9 (R1)Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Periodic Review and RequalificationRequalification shall be carried out to ensure the equipment should be maintained in a qualified state throughout the life-cycle of the same
Performance Qualification [PQ]To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods