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.

Contact Us

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.
Contact Us
GxP Consultancy
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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

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

Browse Audit Library
REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

Learn More
REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

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

Learn More
REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

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

Learn More

Related Resources

Ensuring Compliance and Data Integrity in Pharmacovigilan QMS

From local to global: scaling your QMS for UK–EU operations

Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan QMS

Scale Your Quality System from UK to EU Without Losing Control

Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.
Read More
SAP PALEX CSV Case Study Header Image (1500 x 844 px) Article

Pharmaceutical Equipment Qualification & Control System Validation

Qualifying process equipment and control systems is fundamental to GMP compliance. This guide breaks down how to define user requirements, apply risk-based testing, and maintain ...
Read More
mock inspection blog header Case Study

GMP Consultancy for a New Cannabis Manufacturing Plant

A start up cannabis manufacturer partnered with Rephine to design a GMP compliant facility, implement a practical Quality Management System and prepare for EU GMP ...
Read More
QMS IMP Header image case study May 25 Article

How an Internal Services Audit Can Maximise Your Regulatory Compliance

Internal services audits play a critical role in maintaining GMP compliance and driving continuous improvement. This article explores how structured gap assessments, internal audits and ...
Read More
GMP Raising the bar Blog series Header image May 25 Article

Effective QMS Management Post-Go-Live: Strategies for Governance, Releases, and Continuous Improvement

After QMS go live, compliance and performance depend on strong governance, structured release management and continuous improvement. Learn how to sustain control, adoption and long ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

GMP Consultancy for a New Manufacturing Plant

With only a small team and a highly automated process, this biotech company needed to achieve EU GMP compliance fast. This case study shows how ...
Read More
CPV Header image case study apr 25 CSV

EU GMP Draft Updates Explained: Chapter 4, Annex 11 and the New Annex 22

This expert Q&A session explores the draft EU GMP updates to Chapter 4, the revised Annex 11 and the new Annex 22 on Artificial Intelligence. ...
Read More
ICH E6 Guide Header Image (1500 x 844 px) Article

Why Quality Can No Longer Live in Silos

Discover why siloed quality management is no longer sustainable in life sciences. Learn how integrating audits, advisory services and digital quality systems supports continuous GxP ...
Read More

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: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards
Explore Gold Solutions