Changes in 21 CFR Part 11 Subpart C, Electronic SignaturesChanges in 21 CFR (Code of Federal Regulations) Part 11 Subpart C Electronic Signatures § 11.100 General requirements.
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...
WHO Technical Report Series TRS 1044, 2022 56th ReportWHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
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
Operational Qualification [OQ]Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.