Dr Rainer Kahlich, GMP/GDP Inspector, Germany
Robert Kayum, Masters Speciality Pharma, UK
Peter Kralinger, Carrymed, Austria
Dr Torsten Schmidt-Bader, moveproTec, Germany
Learn how the experience made in the pharmaceutical cold chain can support strategies for transport at “ambient” conditions.
Challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into play.
Handling and control of cold chain products (2 – 8 °C) have been known for a long time. However, the distribution remains extremely challenging. The approvals of various COVID-19 vaccines in many countries at the beginning of 2021 illustrated the importance of distribution of temperature-sensitive medicinal products – and the challenges involved.
With the implementation of the revised EU-GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use) it became clear that control is needed also for all other products, e.g. for those which need to be stored at so-called ambient temperature conditions. Consequently, the temperature should be monitored during storage and transport.
This training course was developed for managers, executives, Responsible Persons (RP’s), technical staff and other employees from companies involved in the supply of pharmaceutical products.
Current EU Regulatory Challenges
- EU-GDP Guidelines for Medicinal Products and APIs
- The impact of the GDP guidelines on the cold chain
- EU-GDP Chapter 9: Requirements, Clarification and Implementation
- Well-known or new: transport at storage conditions
- Transport conditions
- Risk assessment
- Using dedicated vehicles or not
- Containers, packaging and labelling
- Products requiring special conditions
- EU-GMP Guidelines and Annex 15
- Expectations of the agencies
- Trends in GDP Inspections
The Complicated Logistics around Medicinal Products and APIs
- Differences in the transport of APIs and medicinal products
- The latest developments in packaging and Distribution for temperature sensitive products and materials
- How to find a good transport service Provider
- Refrigerated shipment, cold chain management and transport at ambient conditions – avoiding deviations
- Examples and solutions
Quality Management and Operating Procedures
- How to apply quality systems to manage Distribution processes
- Necessary elements of the quality management System
- Operating Procedures and how to apply them throughout the supply chain
- Creating an ongoing quality strategy for distribution processes and procedures
The Role of the Manufacturer – from Stability and Packaging to Distribution
- Understanding the needs of the supply chain
- Pulling in three directions – quality, costs and time
- Solutions for packaging and containers
- Information flow along the supply chain: from stability studies to deviation handling
Temperature Control: Building Up an Efficient Supply Chain for Medicinal Products and APIs
- How to perform shipping studies
- How to use risk assessment and Management
- Limitations and capabilities of packaging components and containers
- Data logger: when, where and how many?
- Strategies and solutions to meet the regulatory expectations
Application of Cold Chain Standards for Ambient Temperature
- Cold and Cool Chain: validation and risk Management
- Strategies and tools to assist in defining validation exercises
- Risk Assessment and validation master planning
- Qualification and testing of active Systems
- Lessons learned and how the experience made can support strategies for transport at ambient conditions
- Possibilities and boundaries of transport validation in: road transport, air fright, sea transport
The Role of the Qualified Person and the Responsible Person
- The intensified role and responsibilities
- When does the responsibility of the QP end?
- How to handle deviations during storage and Transport
- Best practices for co-operation
A Global Approach to the Control of Transports at Ambient Temperature
- Information needed to perform a sound Risk assessment
- How to get all the relevant data
- Qualification and validation: benefits and Limits
- Data Management: what to do with all the data
Danger in the Air – How to Control Air Transport
- Recent GDP developments in pharma airfreight
- Challenges at airports and how to deal with them
- Best practices
- Controlling temperature at the airport and on airplanes
- Optimising and securing load Position
- Communication and co-operation with custom
Workshop to Discuss the Most Important Questions
- Do all transports have to be monitored?
- Can we deviate from storage conditions during transport if the manufacturer agrees?
- How can risk assessment give us more flexibility?
- When can I use Mean Kinetic Temperature Calculation (MKT)?
- What has to be done in the case of deviations?
- Who is responsible for the decisions?