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.

The distribution and transport of medicines and active ingredients (APIs) are key activities in the supply chain.

Project Compliance Lifecycle

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Related Resources

CSV

Streamlining Analytical Instrument Qualification & System Validation (AIQSV) Guide

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.

CSV

Essential Guide to EU GSPR Compliance for Medical Devices

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Cloud systems maintenance guide header image

CSV

Maintaining Cloud Systems – A Continuous Effort

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Close up of nurse holding and typing on tablet

Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...

Company News

Tim Hawkins Joins Rephine as CEO to Spearhead Global Leadership

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...