5 Months on – and how are we doing?
For those of us living in Europe, September is that month when that wonderful summer vacation taken in July and/or August is sinking ever faster from our memories. It is a time to remember when temperature control had more to do with cool beers, ice cubes in our vodka Martini and balmy summer nights.
But for many of us in the healthcare manufacturing, distribution and logistics sectors, September 8 had a more significant meaning to Temperature Management. After a six-month implementation period, the latest version of the European Union Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) came fully into force. This set of revised GDP regulations also incorporates the requirements of the EU Falsified Medicines Directive.
The original set of GDP guidelines had been in force for almost two decades, and clearly revision was needed to reflect the considerable changes that had taken place in European distribution, import and export of medicinal products and particularly those having sensitivity to temperature control. The consultation period for these new guidelines generated a considerable amount of feedback from manufacturers, wholesales, distributors and other logistics stakeholders.
It was obvious that everyone wanted to have their say and there was much discussion about the Guidelines, their practicality and their economic implications. Many from the distribution and logistics sector felt that in the draft form, the new rules represented a considerable extra cost burden especially with the guidelines that would require the creation of a vast number of additional ‘wholesalers’ who had done no more than hold that shipment ready for transportation, for more than 24 hours.
Imagine – it is Friday evening and that pallet delivered today for shipment on Sunday morning suddenly requires a transportation company to hold an expensive distribution license with all that entails. This element was thankfully dropped in the final GDP document.
But what the new Guidelines have done is strengthen the process of control and responsibility that needs to be in place for effective and safe distribution. Through its 10 Chapters, it aims to create a clear sense of ownership. Though originally suggesting it would ‘police’ compliance throughout the supply chain, it has placed that burden clearly on the shoulders of healthcare manufacturers wholesalers and brokers who must audit their supply chain and all its elements.
Though not specifically mentioned in terms of its temperature range, there has been much focus on the needs of so-called ‘CRT’ products, with many people believing that this remains a prime area of focus for the regulations. And perhaps with just cause since there has been insufficient concern about these types of products particularly where mainland European distribution is generally made by road and where the logistics chain has been particularly fragmented.
Whilst hub-to-hub temperature-controlled vehicles are available, it is a different case further down the logistics process where local distribution and final delivery has long been of concern for CRT temperature-sensitive products. At a recent European workshop, there was much discussion from manufacturers bemoaning the lack of availability of ‘final mile’ temperature-controlled vehicles.
So correct packaging remains a vital part of supply chain integrity, particularly since the new guidance requires that …”for temperature-sensitive products, qualified equipment, (e.g. thermal packaging, containers or vehicles) should be used to ensure correct temperature…..”. And if the recent IQPC ‘Cool Chain & Controlled Room Temperature Logistics Europe’ event is any indication, there is certainly no shortage of thermal packaging suppliers around to serve this sector. Currently only one provider, CSafe, has focused on being able to offer both active and passive solutions, thereby giving manufacturers the surety and benefits that a single approved supplier can bring.
Cold Chain Logistics Solutions
More investments will need to go into scalable GDP certified cold chain transportation solutions in which the combination between technology and cooling plays a critical role. It is expected that the “new GDP” Guidelines, launched end of 2013, will give a further push to this. At the same time pharmaceutical companies must also challenge their own “interpretation” of GDP requirements related to the real transportation requirements of their products across the various markets. There are many industry examples where “ambient” products have been shipped as “cold chain” when the legal product requirement to do so is not there. Passive packaging has also become more cost-effective making it easier to ship products with normal courier companies. A clear interpretation based on the intended regulations can often provide further opportunities to reduce costs to serve and help simplify the logistics delivery service solution.
So 5 months on from implementation and how are we doing? For many of the bigger players in the pharma logistics sector, these revised guidelines have been taken in their stride. But for others, full compliance to GDP has been a major wake-up call.
Manufacturers beware – your audited supply chain needs you!
Edwin Visser, CSafe Global Director of Sales EMEA