4/5 February 2020
Kane Edgeworth, Biomap, U.K.
Afshin Hosseiny, Ph.D., Tabriz Consulting Ltd., U.K.
Dr Zvonimir Majic, Teva Pharmaceutical Industries Ltd., Croatia
Emil Schwan, Medical Products Agency, Sweden
During this course, well experienced speakers will share their expert knowledge about all relevant aspects regarding the current GMP and GDP requirements and current developments in storage, transportation and Cold Chain Management of medicinal products. You will learn how these requirements evolve and how they can be implemented efficiently.
Globalisation, counterfeiting problems and the expectations regarding pharmaceutical storage, transport and cold chain management are forcing the pharmaceutical industry to challenge their current practices. Companies have to increase their effort and validation activities as one prerequisite for safe and secure storage and transportation of their medical products over boarders and through various climatic conditions.
Directives, Guides, Guidelines and initiatives from various regulatory bodies lead the way in this development and define expectations and requirements, where Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are closely linked.
Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products. (EU-GDP Guidelines)
This education course is designed for all managers, supervisors and other staff members who are involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.
Regulatory Requirements and Guidance
- What are the rules and regulations?
- Who is responsible for maintaining product quality in the supply chain
- Cold Chain and ambient storage and transportation
- The revised EU Guidelines on Good Distribution Practice (GDP)
- Who needs a Responsible Person (RP)?
The Roadmap to Success
- Background and comments
- Delineation of responsibilities
- Introduction to the checklist
Best practices in Storage
(how to implement requirements and stay efficient)
- Defining your specification
- How to set up an adequate storage facility
- 15-25°C and 1-8°C storage
- Warehouse, vehicle & cold storage case studies
- Protocol preparation
- Seasonal variations
- Impact tests
- Results and reporting
Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored. (3.19)
An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. (3.2.1)
If temperature-controlled vehicles are used, ... temperature mapping under representative conditions should be carried out. (9.4)
Workshop: Understand your Supply Chain
- Selection of the supply route
- Process mapping of a supply chain
- Developing a QMS for supply chain (Policies, SOPs, documentation & Training)
Cold Chain Management and its Validation
- Validation of transport and hold time
- Validation vs. monitoring
- Qualification of various transport routes
- Data collection and evaluation
Best Practices in Transport and Logistics
- How to implement the requirements and stay efficient
- Managing 15-25°C and 2-8°C transportation
- Challenges that different modes of transportation introduce to pharmaceuticals
- What should industry do and deliver
- Using stability data to assist in supply chain design
- What is the necessary data to discuss excursions
- Discussion of possible deviations and excursions
Supply Chain Security
- Anti-counterfeiting strategies
- What the agencies can do
- What industry can do
- Compliance issues
Import and Export under new Circumstances
- New and possible future regulations impacting import and export (e.g. Annex 21, MRA)
- Political developments impacting import and export (e.g. Brexit, trade Embargos)
Roadmap to Good Distribution Practice
All participants receive a Roadmap to Good Distribution Practice containing:
- An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
- A checklist for the implementation of GDP principles