Method Validations – Qvents

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1 minute read Guidelines

Updated on June 12, 2025

Updated on June 12, 2025

ICH Q2(R2): Validation of Analytical Procedures; Final Version; Adopted on 1 November 2023
ICH Q(14): Analytical Procedure Development; Final Version; Adopted on 1 November 2023
ICH Q2(R2)/Q14 EWG Working group presentation; Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
VICH: Validation of Analytical Procedures: Definition and Terminology [CVM GFI #63 (VICH GL1)]
VICH: Validation of Analytical Procedures: Methodology [CVM GFI #64 (VICH GL2)]
USFDA Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry
USP 1225: VALIDATION OF COMPENDIAL PROCEDURES (Please access USP to read)
Validation of Analytical Methods (IPC/GD/04) – Indian Pharmacopeia convention
EDQM: Comparability of alternative analytical procedures (5.27) (Refer Ph Eur)

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