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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
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Good Distribution Practice (GDP) – English Course & Certification
Beginner
4.6
★★★★★
94% Recommended
7 hours
248 active users
7 points
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About
Good Distribution Practice (GDP) ensures that medicinal products are consistently stored, transported, and handled under suitable conditions throughout the supply chain. It safeguards product quality, integrity, and availability, preventing risks such as contamination, mix-ups, and temperature excursions during distribution.
This Good Distribution Practice (GDP) – English Course & Certification provides a structured understanding of GDP requirements based on EU and UK guidelines. The course covers the regulatory background of GDP, roles and responsibilities, facility and equipment requirements, documentation standards, distribution processes, handling of complaints and recalls, counterfeit prevention, and self-inspection practices. Upon completion, learners receive a certification demonstrating their understanding of GDP principles and compliant pharmaceutical distribution practices.
Who Should Enrol?
- Pharmaceutical Distribution and Supply Chain Professionals
- Warehouse and Logistics Personnel
- Quality Assurance (QA) and Quality Control (QC) Staff
- Responsible Persons (RP) and Licence Holders
- Regulatory Affairs Professionals
- Transport and Cold Chain Management Teams
- Pharmacy and Healthcare Distribution Staff
- Life Science, Pharmacy, and Biotechnology Graduates
- Anyone involved in storage, handling, or distribution of medicinal products
What you will learn
Understand Good Distribution Practice (GDP), regulatory requirements, and the legal framework for pharmaceutical distribution and supply chains.
Learn the roles and responsibilities of management, responsible persons, and distribution personnel in maintaining GDP compliance.
Develop knowledge of warehousing, storage conditions, temperature control, transportation, recalls, and handling medicinal products with special requirements.
Gain understanding of documentation practices, quality risk management, counterfeit medicine prevention, self-inspections, and compliance procedures in pharmaceutical distribution.
Course Syllabus
- Rationale and Development
- A Brief History of GMP and GDP
- What Is the Legal Basis for GDP?
- UK and EU Legislation
- Key Legislation in Non-EU Countries
- Provision of Information to Authorities
- Management and Licence Holders
- Responsible Person
- Warehousing and Distribution Personnel
- Facilities and Equipment – General
- Receipt
- Storage
- Temperate Storage
- Cold Storage
- Temperature Mapping
- Alarm Systems
- Orders
- Procedures
- Project Quality Training Record
- Policy and Procedures
- What Should SOPs Cover?
- Performance Indicators
- Quality Risk Management
- Records
- Key Points
- Transportation
- Deliveries
- What About Goods With Special Requirements?
- Complaints and Returns
- Actions for Returns of Non-Defective Medicinal Products
- Distribution – General Points
- Recalls
- Recall Classifications
- Recall Procedure
- Destruction
- Counterfeit or Falsified Products
- The EU Falsified Medicines Directive (FMD)
- The EU Falsified Medicines Directive (FMD)
- FMD Packaging Safety Features
- Training
- Who Should Carry Out Self-Inspections?
- Inspection Readiness
- References and Links
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any legislative changes in GDP as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed to ensure that you comply with GDP legislation through the application of learning outcomes. The course is written by Louise Handy, who is a former chair of the Research Quality Association (RQA
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