David Abraham, Quality Resource Solutions Ltd.
Dr Zvonimir Majic, Teva Pharmaceutical Industries Ltd., Croatia
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.
During this Live Online Training, well-experienced speakers will share their expert knowledge about all relevant aspects regarding the GDP requirements for logistic vendors. You will learn how these requirements evolve and how they can be implemented efficiently to bring and keep your organization in compliance with the GDP regulations. Furthermore, different certification options for logistic vendors will be discussed. Practical examples and exercises (including polling questions) and a Q&A session ensure interaction and that all questions are answered.
Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain.
The EU GDP-Guidelines are intended to ensure control of the distribution chain and consequently maintain the quality and integrity of medicinal products. Each manufacturer of a medicinal product needs to control and supervise the supply chain (wholesaler, transport and distribution companies etc.) of the finished products.
In the supply chain, many logistic activities are outsourced to service providers, e.g. logistic vendors. Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities. Therefore transport companies need to follow GDP but will not receive a GDP certificate.
An independent assessment of compliance against international GDP requirements could be an effective way for logistic vendors to establish that their Quality Management Systems (QMS) align with the GDP requirement.
‘ISO’ is an abbreviation for the International Organization for Standardization, an independent, non-governmental international organization. There are a variety of ISO standards that transport and logistic companies can implement. Achieving an ISO certification means implementing a management system that improves the processes and procedures. Before signing a contract, a standard question may be about the type of certificates the company holds. In this way, quality standards can help to gain a competitive advantage in the transport and logistics sector. ISO 9001 is a generic quality management system providing a good framework for any organisation. However, the EU GDP expectations are not clearly detailed in this standard. It is therefore recommended that companies using the ISO framework incorporate the specific GDP requirements to ensure a compliant and workable QMS is available for the company.
This Live Online Training is aimed at all personnel of logistic vendors, but also to management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in the distribution of medicinal products.
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Mastering Supply Chain Risks
- Understanding supply chain impacts
- Threats, vulnerabilities and impacts
- The role of Due Diligence
- Management of supply chain security measures (TSM)
Quality and Risk Management Systems
- QRMS procedures – customer focus and compliance requirements
- Risk management – risk assessment of lanes, cross dock operations, transport mode and shipping systems (active, passive), transport vehicles and Containers
- Quality agreements and SLA requirements
- Supplier management
- KPIs and performance Management
Standards and Guidance in Supply Chain
- Supply Chain Standards
- GDP meets ISO
- Certification and selection of logistics suppliers
- Building mitigation into your QMS
GDP Provisions for Transport, Handling and Storage of Time and Temperature sensitive Pharma Products in Supply Chain
- Specific provisions and requirements for air, ocean and road transport
- Specific requirements for in-transit storage premises and cross docks
- Certification requirements and industry best practices
- Continuous monitoring and improvement programs for logistics
- Monitoring technologies and requirements
Practical Examples / Exercises
(Dr Zvonimir Majic and David Abraham)
- Applying supply chain learnings
Questions and Answers Session
(Dr Zvonimir Majic and David Abraham)
- Participants are invited to ask questions