Module 3 - Strategic case studies in practice

5. REFERENCES International Conference on Harmonization; " Impurities in New Drug Substances ", 1995. International Conference on Harmonization; " Impurities in New Drug Products ", 1996. International Conference on Harmonization; "Stability Testing of New Drug Substances and Products ", 1994. International Conference on Harmonization; " Text on Validation of Analytical Procedures ", 1994. International Conference on Harmonization; " Validation of Analytical Procedures: Methodology ", 1996. International Conference on Harmonization, " Residual Solvents in Pharmaceuticals ", 1996. International Conference on Harmonization, “ Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products ”, 1999

6. ATTACHMENTS: DECISION TREES #1 THROUGH #8 For the decision trees referenced in this guideline, see the following pages.

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