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About Apic GDP 2017
This document provides guidance on good distribution practices for active pharmaceutical ingredients according to EU regulations. It discusses responsibilities of parties involved in API distribution, including manufacturers, distributors, and finished drug product manufacturers. It emphasizes the importance of quality agreements that clearly define roles and assess supply chain risks. Assessments should evaluate actual transport conditions to ensure API quality is maintained according to stability data. The qualified person of the drug product manufacturer has overall responsibility for the distribution process.
Detailed Information
| Author: | ['dinu344'] |
|---|---|
| Publication Year: | 2018 |
| Pages: | 14 |
| Language: | English |
| Format: | |
| Price: | FREE |
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