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You have probably heard of ‘harmonisation’, but what does it mean? The answer depends upon your business model, product mix and business objectives. A multinational corporation is no longer simply a company that operates outside its geographic homeland; it is a centrally controlled business organisation that coordinates and combines business processes in order to create a competitive advantage, regardless of its geographic location. Anyone working towards global harmonisation will also know that it is easier said than done. This broad and lofty goal is constrained by specific business unit requirements, legacy systems, time zone differences, international monetary exchange, cultural differences and often individual personalities.
This article focuses on harmonised temperature control packaging systems (TCPS) and the challenges faced by the multinational life science industry dealing with temperature control while in transport. The challenges involved in effectively developing, tracking and implementing a TCPS global strategy are compounded by unprecedented economic times that are reshaping the traditional pharmaceutical business model. Meanwhile, unrest exists within many US-based pharmaceutical companies due to the potential takeover of the healthcare system by the Federal Government. New Lean pharmaceutical business models are emerging which focus on third-party expertise in the form of manufacturing, human resources and drug discovery. As a result, the way in which transport and packaging solutions are delivered must also evolve. The pursuit of harmonised TCPS requires careful analysis which blends science, process control, communication, negotiation and good business sense. Before embarking on this discussion, it is prudent to understand that harmonisation is an ongoing process which must be measured and adjusted over time. Just like going to a chiropractor with a sore back, one visit will not solve the problem; instead, the best possible solution is usually (but not always) found over many adjustments.
THE MULTINATIONAL APPROACH
The definition of a multinational corporation has been evolving rapidly. A simple definition is a firm having operations in a foreign territory. The first multinational firms operated in a decentralised manner. The old definition is no longer truly valid, especially in the highly regulated world of pharmaceutical manufacturing. It is ideal from a regulatory perspective to have documented consistency of processes and products across your organisation. Drug products made in Puerto Rico must be made to the same specifications as everywhere else in the world. The advent of the personal computers and the internet has provided multinational corporations with the opportunity to streamline chosen business processes and exploit the knowledge base of their offshore operations. This has been proven to save money and increase the firm’s ability to compete and has led to a more centralised model; we will see this as a trend in the years to come
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