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
Temperature Mapping
- Warehouse, vehicle & cold storage case studies
- Protocol preparation
- Seasonal variations
- Impact tests
- Results and reporting
EU-GMP Guidelines
Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored. (3.19)
EU-GDP Guidelines
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
Shipping Stability
- 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)