USFDA office of regulatory affairs issued ORA laboratory manual volume II on "Methods, Method Verification and Validation". The purpose of the document is to provide the procedure for laboratories for development, validation, and verification of method performance specifications for new methods, modified methods or procedures previously validated externally. To know more please click Read More
ICH - Q2
To have a harmonised procedure across the world, the ICH has issued a various guidelines. One of the guideline for validation is "Validation of Analytical Procedures - Text and Methodology" . This guideline provides the various steps to be followed for execution of analytical method validation. You can read the detailed steps by clicking link Read More.
ICH - Q14 - Q2R2
Type of Harmonisation Action Proposed to develop a new quality guideline on Analytical Procedure Development and
to revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and
the concept paper can be accessed in the link concept paper
Analytical method developed and validated in the analytical development laboratory should be transferred to QC laboratory for routine use.
New analytical method developed in the analytical development laboratory should be validated inline ICH Q2 guideline before using for routine analysis.
Analytical method which is listed in the pharmacopeia should be verified for suitability of the method before using for routine analysis.