Presented by
Management Forum
How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits Training Course
This training will equip attendees with the practical skills necessary to implement regulatory-compliant distribution and storage systems, ensuring both pharmaceutical integrity and patient safety.
14-15 July 2025
+ 3-4 December 2025, 19-20 March 2026 »
from £549
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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- How to Perform Bullet-Proof Good Distribution Practices (GDP) and Good Storage Practices (GSP) Audits
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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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:
- Quality Assurance
- Quality Control
- GMP Compliance
- GDP and GSP Auditors
- Auditing
- IT
- Regulatory Affairs
- Engineering
- Supply Chain
This course will cover:
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: FIFO, LIFO, and 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 conduct an 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 an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
14-15 July 2025
Live online
09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 15629
- GBP 549 749
- EUR 769 1,049
- USD 887 1,199
Until 09 Jun
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
3-4 December 2025
Live online
09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
04:30-12:15 New York (UTC-05)
Course code 15630
- GBP 549 749
- EUR 769 1,049
- USD 887 1,199
Until 29 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
19-20 March 2026
Live online
09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
05:30-13:15 New York (UTC-04)
Course code 15631
- GBP 549 749
- EUR 769 1,049
- USD 887 1,199
Until 12 Feb
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
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
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 in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
