Falling in Line

On March 7, 2013, the revised “Guidelines on Good Distribution Practice for Medicinal Products for Human Use” were published by the European Union (EU) authorities. These guidelines describe the requirements for procuring, holding, supplying and exporting prescription-based and prescription-free medicinal products. They apply the known principles of Good Manufacturing Practices (GMPs) from pharmaceutical manufacturing to the transport of medication to a greater degree.

It has been universally recognised by the pharma industry that these are much needed to ensure transport quality. While globally the standardisation of temperature-controlled transportation of pharma products is developing, the knowledge of smaller non-specialist forwarders, in particular, could still be improved. Pharma manufacturers themselves are getting more proactive about improving their logistics processes. Global MNCs have in-house guidelines to ensure stringent implementation of the worldwide GDP requirements such as the WHO and the EU GDP along with regular audits of the quality management system and the process documentation of their logistics contractors.

Ensuring compliance

It is an undeniable fact that globalisation has had a significant impact on the supply chains of medicinal products. Not only are they getting longer, but are more susceptible to seasonal variations during the storage, transport and distribution of goods. The availability of expertise, infrastructure and equipment for temperature-controlled storage, transport and distribution can differ significantly between countries and continents. These new variables increase quality and safety risks for medicinal products in the supply chain. This is where the guidelines come in as they help prevent adulterations, mix-ups and temperature deviations of products, even reducing theft and falsified medicines entering the supply chain.

Taking about the regulations a spokesperson from Marken, a global clinical supply chain provider, explains that the new guidelines place more emphasis on risk assessment, the role of the named or responsible person, and the heightened scrutiny on transportation requirements. The temperature controlled portion is directly linked to cool chain and even temperatures outside the typical cool chain environment (+15°C to +25°C) are included in the guidelines.

In view of these, becoming and remaining compliant is, of course, a big challenge and undertaking. Not only do all steps, components and actions need be in compliance with the outlined procedures, but it all needs to be verifiable, with documents and proof of shipments and procedures performed. This becomes imperative since GDP inspectors are now carrying out, or are about to carry out, inspections according to the new GDP guidelines. It is critical that the processes are already in place, he adds.

Companies are now reviewing their existing supply chain processes and contractual agreements to ensure compliance and have also updated their SOPs that detail transport conditions depending on product, supplier and season. Based on a transportation and storage validation performed by their quality teams, it ensures that products are transported and handled according to GDP requirements, chips in a spokesperson from Dr Reddy’s Laboratories (DRL).

Each organisation thus needs to embark on a risk-based approach. This involves answering questions such as: What are the various points in their logistics and transportation processes where they need to evaluate the storage, temperature ranges, documentation, validation of processes? How is the stability of the product evaluated and checked at various points to ensure there have been no temperature excursions along the way? Outside temperatures, political changes in the country affecting infrastructures such as roads, blockages, delays, etc all need discussion and back up plans put into place. This is where providers like Marken come in with their IT systems for managing inventory, tracking, and temperature control management as well as proven models to ensure adherence .

Ironing out the roadblocks

Management of subcontractors transporting temperature controlled shipment and required packaging is one of the challenges including making sure that the entire supply chain is covered as per GDP requirements, says the DRL spokesperson. The reality however also is that even though companies might be willing to comply with the international guidelines, many are already managing a range of logistics services and providers who may or may not be in compliance themselves. This means that every pharma company needs to strive for operational efficiency to be able to supply patients with products on time.

According to Luc Huybreghts, Senior Quality Assurance Consultant Pharma Services at Pauwels Consulting, companies need to address this by visualising different parts of the transport process – various modes of transport, storage, and transport handover points. For each part of the transport process, the variables that affect the transport must be described and a risk assessment must be carried out. These include product-related variables (type of product and its stability) on one hand and the process-related factors (outside temperatures in different parts of the supply chain) on another.

Taking into account all the variables that could influence the probability of a risk such as stability data, weather conditions, transport mode and protective packaging while not limiting its severity to patient risk; regulatory risk and business continuity, cannot be missed out. By multiplying the probability scores with the severity scores, a risk score for a certain product or product group for a specific transport route can be obtained.

Risk scores could then influence the transport strategy of a company as well as define the selection of the right distribution and logistics partners or the optimal packaging design of the shipping containers. A good transport strategy must include risk identification and risk mitigation. From the design phase onwards, risks must be under control as much as possible.

The GDP guidelines are perfectly timed for today’s pharma and cool chain management because the industry is increasingly focused on patient-centric improvements striving to bring products to market quickly, but more importantly, safely. These requirements ensure that all organisations are working towards the same goals of patient safety by utilising the right packaging, ensuring the right temperature is maintained for product stability, and making improvements to benefit all of us.

The guidelines are just as sustainable as other regulations (GCP, GLP, GMP); their impact however, will depend on the results of the inspections – how many pharma organisations are ready, prepared, in compliance? If they are not, remedies will need to be put into place, which can of course take more time and effort. However, if organisations are now compliant, the new guidelines are clear and will certainly improve processes that should continue to be refined going forward.

The supply chain was probably the weakest link and now will operate at the same or higher standards than other parts of the industry, concludes the spokesperson from Marken. It’s likely that changes and improvements will continue to evolve as the focus continues to be on improving product and patient safety in the future.

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