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Title OpDiv/StaffDiv Guidance Status Issue Date
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin  Food and Drug Administration (FDA) Final
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products  Food and Drug Administration (FDA) Final
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products  Food and Drug Administration (FDA) Final
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability  Food and Drug Administration (FDA) Final
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process  Food and Drug Administration (FDA) Final
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products  Food and Drug Administration (FDA) Final
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry  Food and Drug Administration (FDA) Final
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Final
Q8(R2) Pharmaceutical Development  Food and Drug Administration (FDA) Final
Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)  Food and Drug Administration (FDA) Final
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