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Pharmaceutical Manufacturing and Packing Sourcer

Best Practice


Manufacturers and suppliers of pharmaceutical products place a huge importance on product integrity and supply chain visibility, in order to provide the right product – with the right quality and quantity – at the right time and place. During manufacturing, handling, storage and distribution, these medicinal products are exposed to risk of damage, theft, temperature extremes, counterfeiting, tampering, and many other conditions which might impact the product availability, efficacy and quality for the end-user: the patient. With this in mind, the application of risk mitigation actions should protect the patient, the product and the supply chain.

Taking place on 14-15 October in Berlin, Germany, the Pharmaceutical Cold and Supply Chain Logistics conference will aim to address these issues, suggest a variety of solutions, and invite debate.

On the Agenda

Speakers will focus on this year’s theme: ‘Ensuring product integrity and visibility across the supply chain’. In addition, they will address the establishment of a product stability budget for the supply chain, as well as Good Distribution Practices (GDP) related to regulation, contract management, temperature control and transport integrity. Serialisation and the fight against theft and counterfeiting of medicinal products will be discussed too.

Session 1: Supply Chain Visibility

Patient safety is a fundamental principle that takes centre stage in the pharma supply chain. It is the key driving force behind the development of patient protection initiatives at national, European and international levels.

This session will look at some of the challenges and opportunities that await supply chain stakeholders who start to pursue a new approach to ensure all patients receive only genuine medicines at the point of dispense. The European Stakeholder Model – a partnership of key supply chain stakeholders including pharma companies, parallel traders, wholesalers and pharmacists – will be used as a reference to demonstrate how stakeholders can efficiently and cost-effectively conceptualise,  develop, deploy and govern medicinal verification systems.

The speakers will examine ways of enhancing supply chain visibility through standardisation and harmonisation of product coding and identification systems. The encountered challenges and pitfalls in the development of such serialisation projects will be discussed and assessed, before concluding with a look at how future visibility and security levels are likely to be improved.

Session 2: Stability Budget
There is increasing evidence that many pharma products are more stable towards heat than their labelling suggests, and can remain effective despite having been exposed to warmer temperatures. The concept of a ‘stability budget’ considers stability studies’ results to determine the amount of time that a product can experience out-of-storage conditions without posing significant risk to its quality. It can provide a useful guide to addressing temperature chain concerns that may arise during manufacturing and distribution. This session will not only review this area, but also advise how it can be applied.

Session 3: Contract Management
Any outsourced activity covered by the GDP guidelines should be correctly defined, agreed on and controlled in order to avoid misunderstandings which could affect the integrity of the product. Regulatory, wholesaler and logistics service providers’ perspectives on outsourcing of logistics activities will be shared in this session.

Session 4: Product Integrity
Both industry and regulatory expectations surrounding the pharma supply chain are expanding to include the broader perspective of supply chain integrity. A host of new terms are commonly referred to when talking about industry best practices – supply chain security, continuity, integrity and transparency are now all commonly interchanged. This session will explore current best practices for ensuring a product’s integrity as it travels through the increasingly complex pharma supply chain. Industry strategies to thwart product theft and counterfeiting will be explored, all with a focus on risk mitigation.

Session 5: Temperature Control
Regardless of the mode of transport, it should be possible to demonstrate that medicines have not been exposed to conditions that may compromise their quality and integrity. In this session, industry representatives will present case studies on how to improve temperature control during shipping and how to handle temperature excursions.

Session 6: Regulatory Update
Regulators from Spain, Ireland and the Netherlands will share their thoughts regarding the challenges and audit trends as EU GDP is being implemented. An overview of the New Irish Guidance 2014 and how it compares to the EU GDP of 2013 will also be presented.

Session 7: Transport Integrity
The International Air Transport Association and airlines are proactively cooperating with supply chain stakeholders to understand, communicate and interpret industry-wide standards for shipping time and temperature-sensitive medicinal products. Industry representatives will share their experience on how such challenges are addressed and why temperature monitoring is an important part of the process.

Extra Value

As in previous years, we have also scheduled two roundtable discussions and a networking event, giving participants the opportunity to connect with speakers, inspectorate representatives, pharma and cold chain leaders, and suppliers of logistics solutions – for example, temperate monitoring systems, or active and passive containers.

After the event, a two-day training course, entitled Good Cold Chain Practices, will be available from 16-17 October, where attendees will be addressed by professionals in GDP, stability budgeting, risk management, qualification of active and passive containers, and temperature monitoring. A mix of both theoretical and practical experiences will be on offer.

The course will focus on training, discussion and elaboration on the following four main topics:

Module 1: Stability Budget for the Supply Chain

Tools and methodology to assign the amount of time out of storage that a drug substance may experience – without any significant risk to its quality, efficacy and potency – will be provided in this module. The discussion and training basis is PDA Technical Report 53 on Stability Testing.

Module 2: Risk Management for Temperature-Controlled Distribution
In this module, attendees will be introduced to risk concepts and management tools, terminology, ICH Q9 guidance and PDA Technical Report 58. A failure mode and effects analysis exercise will provide insights into risk management and understanding of today’s risks in active and passive temperature controlled shipping systems in the supply chain.

Module 3: Developing and Qualifying Shipping Containers
This interactive module provides the good practices needed to qualify active and passive temperature-controlled shipping systems. The various insulation materials, diverse types of temperature stabilisers (phase change materials), basic principles of thermodynamics, mechanical stresses and PDA Technical Report 64 are other themes which will be explored too. Class exercises will aim to provide trainees with a greater understanding of the complexity of shipping containers.

Module 4: Temperature Monitoring and Analysis
A comprehensive, technology-focused insight into the different types of temperature and humidity monitoring devices will be offered in this module, including available sensor principles and device configurations. A new methodology for developing ambient temperature profiles will also be presented, providing a risk-weighted evaluation of the cost of maintaining quality via thermal protection and speciality logistics services.

Why Attend?

The Pharmaceutical Cold and Supply Chain Logistics conference is a great opportunity for you and your company to gain on-site exposure in front of highly-qualified, upperlevel professionals in the pharma and biopharma industry. The subject knowledge of enthusiastic speakers, the background behind the case studies and regulators’ experiences will drive this event to connect people, science and regulation, while offering an opportunity to learn more about the industry’s best practices.


Join us in Berlin from 14-15 October to gain insightful tips and form new contacts within the pharma logistics sector. For the full programme of speakers and sessions, or to register, visit: https://europe.pda.org/index.php


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Erik van Asselt studied Chemistry at the University of Amsterdam, The Netherlands. Following this, he attended the University of Groningen where he received his PhD in Mathematics and Natural Sciences by the elucidation of 3D protein structures using X-ray crystallography. Since 2000, Erik has worked at Merck, Sharp & Dohme, The Netherlands. He started as Stability Coordinator and subsequently became Supervisor of the stability laboratory. In 2007, Erik moved to the position of Improvement Engineer, where he is now responsible for cold chain management, logistics, budgets and improvement projects. 

Dr Rafik H Bishara
received his PhD from Purdue University, US, adding to his BS in Pharmacy and Pharmaceutical Chemistry, and an MS in Phytochemistry from Butler University, US. During his tenure at Eli Lilly, Rafik was responsible for quality knowledge management, global compendial affairs, stability and distribution excellence, global product protection, special security substances and controlled substances administration. He has worked consistently towards harmonisation of many global regulations and guidelines for the transportation of pharma and biotech products, and has chaired and presented at many leading industry conferences.
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Erik van Asselt
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Dr Rafik H Bishara
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