Part of Audit Essentials: From Interviews to Inspections series:

Led by industry expert Mustafa Edik, this comprehensive new training series is designed for professionals in the pharmaceutical industry who want to master GMP audits. Learn how to conduct thorough audits, manage supplier assessments, and confidently handle regulatory inspections. The courses in this series cover everything from raw material audits and GMP compliance to overcoming challenges and maintaining audit readiness for major health authorities like the FDA, EMA, and WHO. Additionally, you’ll gain crucial knowledge of Good Distribution Practices (GDP) and Good Storage Practices (GSP) to ensure product quality and safety. Ready to elevate your auditing expertise and stay ahead of industry standards? Enrol today!

Course overview

Adhering to Good Distribution Practices (GDP) and Good Storage Practices (GSP) is essential to ensure that pharmaceutical products reach patients and healthcare providers in optimal condition, thereby safeguarding patient health and maintaining compliance with regulatory standards. In the pharmaceutical industry, it is as crucial to store, transport, and distribute products in a manner that preserves their quality and integrity as it is to manufacture them.

This training is designed to provide you with a comprehensive understanding of GDP and GSP principles and best practices. You will learn the key aspects of distribution and storage systems, including temperature control, traceability, documentation, and risk management, to ensure compliance with international regulations (such as those set by the FDA, WHO, and the EU) and industry standards.

By the end of this training, you will have the practical skills and knowledge to implement robust distribution and storage practices within your organisation. Whether you are managing a warehouse, overseeing logistics, or working in quality assurance, this programme will equip you to ensure that pharmaceutical products are handled and transported in full compliance with GDP and GSP requirements.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

Enhance your understanding of the key principles and regulations behind Good Distribution Practices (GDP) and Good Storage Practices (GSP)
Get up-to-date with the latest global regulations and industry standards from regulatory bodies like the FDA, EMA, WHO, and ICH
Learn how to assess and mitigate risks associated with product distribution and storage
Discover how to implement best practices for ensuring the proper storage and transportation of temperature-sensitive products, such as vaccines and biologics
Gain practical knowledge on the implementation and management of temperature-controlled storage and transportation systems
Enhance your ability to oversee and manage the end-to-end distribution and storage processes

Who should attend

This training will suit those in the following departments/roles:

Quality Assurance
Quality Control
GMP Compliance
GDP and GSP Auditors
Auditing
IT
Regulatory Affairs
Engineering
Supply Chain

This course will cover:

Day 1
Day 2

Introduction to good distribution practices (GDP) and good storage practices (GSP)

Overview of GDP and GSP principles and regulations
Importance of GDP and GSP in the pharmaceutical supply chain
Key regulatory bodies: FDA, EMA, WHO, PIC/S, MHRA, ICH standards
Role of GDP and GSP in ensuring product quality and safety

Regulatory framework and compliance requirements

Detailed review of GDP and GSP regulations and guidelines
Understanding the global regulatory landscape: FDA, EMA, WHO guidelines
Common compliance challenges and how to address them
Industry best practices for maintaining regulatory compliance

Risk management in distribution and storage

Identifying and assessing risks in the distribution and storage process
Importance of risk-based approach in GDP and GSP
Temperature control, handling procedures, and risk mitigation strategies
How to develop a risk management plan for your distribution and storage systems

Good storage practices (GSP) – key principles

Best practices for warehouse and storage facility management
Temperature and humidity control: the science behind storage conditions
Stock rotation methods: First In, First Out (FIFO), Last In, First Out (LIFO), and First Expiry, First Out (FEFO)
Handling and labelling requirements for pharmaceuticals

Temperature-controlled distribution systems

Principles of temperature-controlled transportation and storage
Best practices for managing refrigerated and frozen products
Active-Passive Temperature Controlled Systems
Temperature monitoring devices and validation of systems
Case studies: Real-world examples of temperature excursions, Mean Kinetic Temperature (MKT) and how to handle them

Workshop - how to audit temperature mapping study

Product traceability and documentation

Importance of documentation for compliance and audit readiness
Methods for ensuring full traceability of pharmaceutical products
Documentation standards for GDP and GSP
Implementing effective tracking systems and audit trails

Managing the supply chain and third-party logistics

Collaborating with third-party logistics providers (3PL)
Vetting and qualifying distribution partners
Performance monitoring and quality assurance of external partners

Handling non-conformities and corrective actions

Identifying and responding to product storage or distribution issues
Corrective and Preventive Action (CAPA) in GDP and GSP
Case studies: How to manage temperature excursions, damaged goods, or product recalls
Communicating non-conformities and CAPA processes to stakeholders

Preparing for audits and regulatory inspections

How to ensure GDP and GSP compliance during audits
Key elements that auditors focus on in distribution and storage systems
Best practices for maintaining audit-ready documentation and processes
Preparing for external inspections by regulatory authorities (FDA, EMA, WHO)
Trends in supply chain technology: Blockchain, IoT, and AI

Building a culture of quality and compliance

How to foster a culture of quality and compliance in your organization
Training staff on GDP and GSP: Continuous training, education and awareness
Employee engagement in quality assurance and compliance efforts
Best practices for ensuring ongoing compliance in changing regulatory landscapes

Workshop - how to audit airline cargo companies

Mustafa Edik

Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.

As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.

His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.

Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:

GMP/GDP audits and supplier qualification
Validation, qualification, and quality risk management (ICH Q9)
Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards

Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.

A prolific author, Mustafa's works include:

“Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
“GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices

Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.

More details

Run How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits Live online for your team

Pricing from:

GBP 1,000

Per attendee, based on 10 attendees
Course tailored to your requirements
At your choice of location, or online

Contact us

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our team to discuss your requirements:

How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits In-house Training