IVO CALDERA¹, ANTONIO CONTO²
1. Consultant for pharmaceutical companies, Milan, Italy
2. Chemsafe, Colleretto Giacosa, Italy

Abstract

The discussed re-shoring process meant as the return of pharmaceutical manufacturing to Europe back from far-Est countries, can represent a great opportunity for the EU economy and social benefits. Furthermore it may give more independency for raw important substances along the supply chain from non-EU countries. Nevertheless a re-shoring process must be carefully evaluated concerning two crucial aspects: the technical impact and the regulatory requirements. A preliminary assessment of the re-shoring plan must include, at least, the evaluation of GMP requirements, technicalities to build up a new manufacturing plant, additional departments of adjustments of existing facilities. Furthermore aspect related to Regulatory and HSE requirements and last but not least special products have to be considered. All these activities must reults in a rough budget leading to evaluate the real opportunity to move processes to EU. The investment in a thorough preliminary assessment is the key to the success of the project.

OFFSHORING E RESHORING
With reshoring, European companies bring back “home” those productions that previously, with offshoring, had been relocated to Asian countries, such as China or Vietnam, or to Eastern European countries. As early as 1400, offshoring was practiced by Florentine merchants, who bought wool from England and then sent it to Belgium to be spun, because it was cheaper. The spun product then was given back to Florence, where it was carefully finished to be sold throughout Europe. More recently, in the 1960s, the first US multinational companies began to decentralize some production activities, moving the more standardized and routine activities abroad, exclusively to the countries of the South of the world.

In this way globalization began, “a process by which markets and production in different countries increase their interdependence, exchanging goods and services and transferring capital and technology”, as defined by the OECD (The Organisation for Economic Co-operation and Development). Global trading and international investments, in decades between the 20th and 21st centuries, grew rapidly, creating both ...