Direct Links to important GMP API Guidelines
FDA Guidance for Industry: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
APIC - Sharing Drug Substance M7 information to HA and MAH: “How to do” document - Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing
APIC - Data Integrity - Frequently Asked Questions (FAQ)
APIC - Practical risk-based guide for managing Data Integrity
WHO Protocol to conduct equilibrium solubility experiments for the purpose of Biopharmaceutics Classification System-based classification of active pharmaceutical ingredients for biowaiver
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