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

Case Study

Implementing a Site-Wide CPV Strategy to Strengthen Process Control

Discover how Rephine developed and implemented a site-wide CPV strategy to improve process control, ensure GMP compliance, and reduce manufacturing variability.

Blog

Continued Process Verification (CPV) in GMP Manufacturing

Discover how CPV ensures process control and GMP compliance. Learn key regulatory insights and explore a real case study from Rephine’s validation experts.

AI Act WP MedTech Header Image (1500 x 844 px)

Medical Device

The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Guide

When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Case Study

Navigating DMF Registration in China with Rephine

Explore case study showing the development of a project for a new pharmaceutical manufacturing plant with the objective to fulfill GMP requirements and minimise risks ...

Blog

Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF

Learn how to navigate DMF submission in China with Rephine’s expert guidance. From compliance reviews to NMPA approval — streamline your entry into the Chinese ...

ICH E6 Guide Header Image (1500 x 844 px)

CSV

Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet ...

Blog

AI Data Management & Governance: Best Practices for Compliance

In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, ...

Guide

Understanding Intended Purpose in EU MDR & IVDR: Key Implications for Medical Device Manufacturers

Our guide simplifies GSPR compliance, helping medical device companies meet EU safety standards, streamline CE marking, and get market-ready faster.

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.

Email: [email protected]

Social:

REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

First Name

Last Name

Phone

Country

Company

Job Title

Interested In

Message

Marketing Opt In

Rephine respects your privacy. Choosing to check the box means that you agree to the Rephine Privacy Policy. You can unsubscribe at any time.