MMD-121 Understanding Good Distribution Practice (GDP) for Pharmaceutical & Medical Device Supply Chain
Overview
Course Objectives
Course Content
For Whom
Schedule and Hours
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Good Distribution Practice (GDP) is a quality system that ensures pharmaceutical and medical device products are properly stored, handled, and transported throughout the distribution chain. Its objective is to maintain product quality, safety, and integrity from the manufacturer to the end user by preventing exposure to unsuitable conditions such as incorrect temperature, contamination, or mishandling during storage and delivery.
GDP requires organizations to establish a structured Quality Management System (QMS) that covers personnel competency, suitable premises and equipment, proper documentation, and controlled distribution operations. Companies must ensure appropriate storage conditions, effective stock control, and accurate distribution records to maintain product traceability and regulatory compliance.
In addition, GDP emphasizes proper management of complaints, product returns, suspected falsified products, and product recalls, supported by clear procedures and reporting mechanisms. Regular self-inspections and monitoring of outsourced activities help organizations maintain compliance while ensuring that safe and high-quality products reach healthcare providers and patients.
By the end of this course, participants will be able to:
Be able to understand the basics of Good Distribution Practice for medicinal products for human use and the current legal regulations and guidelines;
Have the confidence to outline the main GDP requirements related to premises, equipment and personnel;
Get familiar with the principles of the GDP quality system and quality management, all the aspects of the transportation of medicinal products and the important procedures when dealing with complaints and recalls
Module 1: Introduction and GDP Quality Management System (QMS)
Module 2: Premises, Equipment and Documentation
Module 3: Operations and Distribution Control
Module 4: Compliance, Monitoring and Transportation
The course is ideal for anyone in a role within an organization that distributes pharmaceutical medicines or involved in such services or materials (raw materials, Active Pharmaceutical Ingredient (API), filters, packaging materials or consumables). This may involve logistics supply chains, including warehousing, transportation, distribution or wholesalers, secondary-packers and labellers.
This is a 1 day programme. This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.