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Practice Guidance for Active Pharmaceutical Ingredients - The Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality
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Part 601 - Licensing Biologics
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EU GMPs with Annex 2 Biological 210 2000 Color 2-sided Glossy CardstockThe EU GMPs include Chapters 1 9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary. Includes Annex 2 Biological Guidelines
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