Good Distribution Practices
The distribution and transport of medicines and active ingredients (APIs) are key activities in the supply chain
The Pharmaceutical Industry, as well as regulatory agencies, are increasing efforts to ensure that active substances and medicines are properly managed throughout the supply chain
Distribution Practices
Globalization and offshoring of the pharmaceutical industry means that the supply chain for medicines and active ingredients is increasingly complex and involves a greater number of agents
In this environment, the distribution and transport of medicines and active ingredients (APIs) for human use are key supply chain activities that must be controlled in order to maintain the quality and integrity of the medicines, as set forth in the European regulations, 2011/62/EU and related Guides 2013/C 343/01 and 2015/C 95/01, as well as current FDA initiatives and expectations.
Control of the Supply Chain
Rephine’s wide experience working both with pharmaceutical laboratories and directly with the main actors involved in the supply chain, allows us to address different risk management strategies and to easily respond to issues.
Characterisation of the Supply Chain
How to identify all the actors involved in the supply chain?
What controls should be established along the supply chain?
Identification of the Agents
Who should have a GDP certificate for the distribution or transport of medicines?
What is a GDP certificate and who can issue it?
Definition of Responsibilities
How responsibilities along the supply chain should be defined?
Good Distribution Practices Services
- Advice and compliance with GDP for distributors and transporters
- Optimization of the supply chain and improvement of control in the supply chain through a risk management approach
- Preparation of regulatory inspections, for the authorization of facilities
- Qualification of facilities and warehouse utilities
- Advise and preparation of the Quality System for logistics and distribution operations.
Project Compliance Lifecycle
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