Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training
Tuesday, 30 April 2024 9 .30 - 16.45 h
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
All times mentioned are CEST.
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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Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023