1. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (March 1999); database.ich.org/sites/default/files/Q6B%20Guideline.pdf, www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
2. EMA Guideline on the Requirements For Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials (January 2022); www.ema.europa.eu/en/requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical
3. EMA Guideline on the Quality, Non-Clinical and Clinical Requirements For Investigational Advanced Therapy Medicinal Products in Clinical Trials (January 2019); www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal
4. ICH Q2(R2) Validation of Analytical Procedures (March 2022); database.ich.org/sites/default/files/ICH_Q2-R2_Document_Step2_Guideline_2022_0324.pdf
5. FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (July 2015); www.fda.gov/regulatory-information/search-fda-guidance-documents/analytical-procedures-and-methods-validation-drugs-and-biologics