Module 3 2019

Recommended references

ICH Q2(R1)

https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf

ICH Q3A (R2)

https://database.ich.org/sites/default/files/Q3A_R2__Guideline.pdf

ICH Q3B (R2)

https://database.ich.org/sites/default/files/Q3B_R2__Guideline.pdf

ICH Q3C (R6)

https://database.ich.org/sites/default/files/Q3C- R6_Guideline_ErrorCorrection_2019_0410_0.pdf

ICH Q3D (R1)

https://database.ich.org/sites/default/files/Q3D- R1EWG_Document_Step4_Guideline_2019_0322.pdf

ICH Q6A

https://database.ich.org/sites/default/files/Q6A_Guideline.pdf

ICH Q6B

https://database.ich.org/sites/default/files/Q6B_Guideline.pdf

FDA Analytical Procedures and Methods Validation for Drugs and Biologics GfI

https://www.fda.gov/regulatory-information/search-fda-guidance- documents/analytical-procedures-and-methods-validation-drugs-and- biologics https://www.fda.gov/regulatory-information/search-fda-guidance- documents/reviewer-guidance-validation-chromatographic-methods

FDA Reviewers Guidance – Validation of Chromatographic Methods

Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)

http://publications.iupac.org/pac/2002/pdf/7405x0835.pdf

ICH Q8 (R2)

https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf

Implications and Opportunities of Applying QbD Principles to Analytical Measurements

https://www.researchgate.net/publication/282481497_Implications_and_ opportunities_of_applying_QbD_principles_to_analytical_measurements

The Organisation for Professionals in Regulatory Affairs