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Pharmaceutical Manufacturing and Packing Sourcer

High Standards

Each year in October, best practices in cold and supply chain logistics are shared, discussed and debated during PDA Europe’s Pharmaceutical Cold and Supply Chain Logistics conference. The 2014 event – which took place in Berlin on 14-15 October – was no different; attendees and speakers from various organisations came together to learn about ‘ensuring product integrity and visibility across the supply chain’, which was the theme of the meeting.

High Priority

Supply chain visibility and product integrity are of vital importance for drug manufacturers and suppliers to provide the right product, with the right quality and quantity, at the right time and place. Product integrity can be defined as:
  • The product is safe, effective and available for its intended purpose
  • The product is handled by business partners that understand each other, their quality systems and their services
  • The product complies with regulations and standards, including Good Manufacturing Practice and Good Distribution Practice (GDP)
It was clear from the lively discussions during the two-day event that the pharma supply chain faces many challenges that might impact product integrity and/or a company’s business. These include, but are not limited to: outsourcing of manufacturing and logistics; serialisation; regulatory pressure for the temperature control of warehouses and shipments; supply chain globalisation; cost reduction pressures; theft; counterfeiting; length of shipments (particularly if transporting by sea); thermal protection of room temperature products; ground handling at airports; and GDP certification of cross-docks, including airport warehouses.

Thus, during manufacturing, storage and distribution, medicinal products are exposed to risks that could impact the product availability and quality to the end-user: the patient.

Conference Highlights

The first day of the conference featured talks on supply chain visibility, stability budget and contract management. Product integrity, temperature control, new GDP regulations, inspections and transport integrity were subjects of the second day.

Lively, engaging and valuable exchanges on the use of stability budget and the impact of the new EU GDP regulation took place during roundtable discussions with regulators from Ireland, the UK, the Netherlands and Spain. Presentations from GS1, Rx-360, the Transported Asset Protection Association, the Medicines and Healthcare Products Regulatory Agency (MHRA), and the International Air Transport Association (IATA) were highly informative and very much appreciated by the audience.

Challenges of Serialisation

Serialisation of finished goods has a major impact on the supply chain. For example, packaging sites need to invest regularly in new equipment and procedures. With this in mind, in her presentation, GS1’s Ulrike Kreysa underlined the importance of a global single standard for two-dimensional matrix coding. Rolling out such standards-based systems globally could prevent tens of millions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain. GS1 estimates that healthcare costs could be reduced by between $40 billion and $100 billion worldwide from the implementation of international requirements standardisation.

Also speaking on this theme, Hans Vanderwegen of 4XScience indicated that aggregation to shipping case is not a requirement according to the EU Falsified Medicines Directive; thus, packaging sites should not over-engineer serialisation, as this will drive up additional costs.

Falsified Medicines
Paul Hargreaves from MHRA shared a number of interesting cases about the document audit trails of falsified medicines. One example concerned authentic medicines that had been relabelled with a new batch number and expiry date. This occurs frequently with HIV/AIDS drugs that are supplied to developing countries under various schemes and at very low cost (a few dollars compared to $500-$1,000).

In recent incidents, authentic medicines were discovered on the market that had been stolen, already purchased and/or were past their expiry date. These drugs were re-labelled with a new batch number and/or new expiry date by counterfeiters. However, some of them were shipped as one large pallet consignment with the correct custom commodity code, but a false custom code had been used. In other cases, the counterfeit medicines were shipped in small quantities, but then mis-declared. Despite these attempted deceptions, customs were able to identify the falsified products at the borders and protect patients against them.

Temperature Control
Royce Heap of Pfizer presented results on the qualification of ocean reefer containers for products that require strict 2-8°C conditions. Unplugging of temperature-controlled containers are part of the risk profile of ocean reefer transportation, so shippers need to provide cost-effective thermal protection to ensure that during these events, temperatures are kept within the specified range, regardless of cold and hot extremes outside.

Various thermal protection systems have recently been tested, explained Heap, including thermal covers, thermal blankets and pallet shippers with insulation foam. In addition, internal and external temperatures were measured over a period of time using several satellite Global Positioning System and Global System for Mobile Communications devices. It became evident during testing that the pallet shipper with insulation foam and +5°C coolants provided the best performance during unplug events in both winter and summer conditions.

Interestingly, the thermal cover system without a base performed better during summer temperatures, while the thermal cover system with a base had better results during the winter.

Certification Programmes
Andrea Gruber from IATA talked about the Center of Excellence for Independent Validators on Pharmaceutical Handling certification programme for supply chain partners at airports. This programme has been developed by IATA for the following reasons:
  • To prevent sanitary issues caused by temperature excursions during transportation of pharmaceuticals
  • To improve the handling of pharmaceuticals in compliance with existing regulations and standards
  • To elevate staff competency levels through efficient and robust training
  • To create a globally consistent and recognised certification that the industry can rely on
  • To ensure product integrity is maintained during transportation until it reaches the end-user or patient
Partners and suppliers at both Singapore Changi Airport and Brussels Airport have begun to implement and follow this certification programme, and more airports look to follow suit.

GDP Inspections
Belén Escribano (Agencia Española de Medicamentos y Productos Sanitarios, Spain), Darren Scully (Health Products Regulatory Agency, Ireland) and Riekert Brunink (Dutch Health Inspectorate) shared the results of the first GDP inspections using the new EU GDP guidance as reference. The overall outcome was reasonable, although many companies are still working on the implementation of the new guidelines. Weak points were the handling of return goods, corrective and preventative action improvements after self-inspections, qualification of suppliers based on quality information, temperature mapping of storage areas, contracts between contract givers and acceptors, and follow-up alarms.

From all presentations, it was evident that the standardisation of guidance, procedures and processes, as well as proactive partnerships within the pharma supply chain, are important elements in ensuring product integrity and visibility across the industry.

Further Guidance

This global conference was attended by 110 participants from 20 countries. In addition, the two-day training course following the meeting was attended by 23 participants from nine countries.

As a follow-up to some of the above discussions, the Co-Chairs of the conference planning committee and the PDA’s Pharmaceutical Cold Chain Interest Group (European and US branches) are pleased to announce that the draft PDA Technical Report on Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance has been submitted to the PDA’s Science Advisory Board, as of 21 November 2014, for review and approval for publication.

The guidance document serves to complement the information provided in previously published PDA technical reports. The first of these was Technical Report 39, released in 2005, on Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, followed by five others (1-6).

The new technical report provides specific guidance on the various types of passive systems available today, including the materials used in their manufacture, their characteristics and capabilities, qualification approach, operational use and reuse, and options for recycling at the end of product life. In addition, thermodynamics inside and outside the shipping systems highlighted here, plus risk assessments for thermal covers, are provided using failure mode and effects analysis methodology; this was previously discussed and applied for other thermal protection systems in Technical Report 58 on Risk Management for Temperature- Controlled Distribution (5).

Looking Ahead

Please mark your calendar for next year’s event on 6-9 October 2015, when we will be meeting in Amsterdam to celebrate the 10th anniversary of PDA’s cold chain conferences and trainings in Europe. We are looking forward to meeting and greeting you in the new location and promise an agenda that will present the latest activities, current challenging topics and details of best practices across the industry.

References
1. PDA Technical Report 39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, 2007 (revision of 2005 publication)
2. PDA Technical Report 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User, 2009
3. PDA Technical Report 52, Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply Chain, 2011
4. PDA Technical Report 53, Guidance for Industry: Stability Testing to Support Distribution of New Products, 2011
5. PDA Technical Report 58, Risk Management for Temperature- Controlled Distribution, 2012
6. PDA Technical Report 64, Active Temperature-Controlled Systems: Qualification Guidance, 2013


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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 three-dimensional protein structures using X-ray crystallography. Since 2000, Erik has worked at Merck, Sharp & Dohme, in 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.
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