Ambient Transport and Cold Chain - Live Online Training
6/7 November 2024
Course No. 21381
Speakers
Peter Kralinger
Carrymed
Dr Rainer Kahlich
GMP/GDP Inspector
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Robert Kayum
Masters Speciality Pharma
All times mentioned are CET.
Objectives
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.
Background
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.
Target Group
Managers, executives and responsible persons from companies involved in the distribution and supply of pharmaceutical products.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
The impact of the new GDP guidelines on the cold chain
EU-GDP Chapter 9: Requirements, Clarification and Implementation - Principles - Well-known or new: transport at storage conditions - Transport conditions - Responsibilities - 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
Case Studies:
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 customs
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?
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials
Seminar Programme as PDF