Paul Andreianu, GDP Consultant
Kane Edgeworth, Biomap
Dr Martin Egger, Pharmaserv Logistics
Dr Christian Grote-Westrick, B. Braun Avitum AG
Ian Holloway, MHRA
Dr Afshin Hosseiny, Chairman oft he ECA GDP Working Group
Saddam Huq, GlaxoSmithKline
Dimitrios Karatzianis, Perishable Center Frankfurt Airport
Johanna Linnolahti, Finnish Medicines Agency Fimea
Sue Mann, Sue Mann Consultancy
- The aim of this conference is to inform about recent experiences made in the implementation of the EU-GDP Guidelines.
- Challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.
- The conference also includes a site visit at the Perishable Center at Frankfurt Airport, Europe’s largest air freight centre for temperature-controlled products.
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.
In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.
To support industry facing these challenges, guidance documents on the GDP interpretation elaborated by the ECA Foundation GDP Interest Group together with the Pharmaceutical Quality Group (PQG) of the U.K. Chartered Quality Institute have been published and will be introduced at this conference.
Stakeholders who hold or plan to apply for a wholesale dealer’s authorisation (WDA) or any GDP certification.
Site Visit Perishable Center Frankfurt (PCF)
Have a look at Europe’s largest air freight centre for temperature-controlled products. At peak times more than 700 tonnes of fresh products are handled per day.
Products are transferred directly from the aircraft to one of the PCF’s 20 refrigerated storage areas. Sensitive goods can be transported in modern temperature controlled trailers from the airport movement area to the warehouse, which has more than 9000 m² of storage space.
In 2015, the PCF was successfully certified by the DQS certification point in accordance with the requirements of the EU-Guidelines on Good Distribution Practice (2013/C 343/01).
Note: For safety reasons, personal data including private address and passport number will be required in advance. Please send us a copy of your passport with the registration. On site, bags might be subject to inspection.
The Guide for Interpretation of the EU GDP Guidelines
Ensuring the Global Integrity of the Supply Chains
- Background on the guidance documents on the GDP interpretation elaborated by the ECA Foundation GDP Interest Group together with the Pharmaceutical Quality Group (PQG) of the U.K. Chartered Quality Institute
- How to use the document
GDP Implementation: Current Experiences of the Inspectorates
- Supply Chain Quality Oversight: Excipients, APIs, Medicinal Products
Designing and Implementing a reliable Supply Chain - from Small Trading Units
- How inspectors approach the challenges
- Good examples of implementation
- Where are the biggest challenges?
to Big Volumes
Workshop on Designing and Implementing a reliable Supply Chain
Risk assessment regarding Storage and Transportation of APIs
- Understanding the challenges of the supply chain
- Effectively working with stakeholders to ensure efficiency
- Control and information flow between partners
- Does size matter?
- Made to measure or bespoke supply chain?
What you need to know about the “Last Mile”(How to control the Uncontrollable)
- Why is it important to perform risk assessments
- Risk assessment approaches
- What you should avoid when performing a risk assessment
Implementation of GDP Compliance into routine Processing: a risk-based and pragmatic Realisation
- What are the requirements?
- What do the inspectorates expect?
- What is tolerable?
- Examples for best practice (and bad practice)
The Perishable Center: our GDP Certification Process
- Risk management strategies for qualification starting points
- Product stability data as input for transport validation and routine release criteria
- Training of GDP relevant people
- Solutions for partitioning tasks of GDP responsible person
Qualification and Use of passive thermal Protection Systems and active Temperature controlled Systems for Distribution
- Introduction of the pharma business at the centre
- How we approached the new requirements
- From gap analysis to implementation
- The DQS and IATA Certificate
- Challenges and best practice
Case Study on Transport Validation
- How to reduce complexity and mitigate risk
- Truck pre-requisites (i.e. equipment and supporting systems)
- Qualification principle and strategy
- Test data from qualification study (i.e. interpretation of data) with examples
- Loading practices
The presentations of the GDP Conference will be available for download and your print-out one week before the conference. You will also receive a USB memo stick when you register in Frankfurt. Note: there will be no print-outs available during the conference.