ICH Quality Q2-Analytical validation and Q3-Impurities Guideline

Analytical Validation

Q2(R2)- Revision of Q2(R) Analytical Validation.

Q2(R2)/Q14 IWG- Training on Validation f Analytical Procedures and Q14: Analytical Procedure Development.

Impurities

Q3A(R2)- Impurities in New Drug Substances.

Q3B(R2)- Impurities in new Drug Products.

Q3C(R9)- Guideline for Residual Solvents.

Q3C(R10) Maintenance EWG- Maintenance of the Guideline for Residual Solvents.

Q3D(R2)- Guideline for Elemental Impurities.

Q3D(R3) Maintenance EWG- Maintenance of the guideline for elemental impurities.

Q3D Training- Implementation of guideline for elemental Impurities.

Q3E EWG- Guideline for Extractables and Leachables.