According to the new global concept of quality which prevails today in the industrial world, the process of harmonization of the standards referring to quality assurance of the product is clearly aimed at creating basic manufacturing regulations. A global control over the quality of the manufacturing process would involve the maximum guarantee of producing a good final product.

This is why today, the basic requirement to allow the import of a pharmaceutical product is to demand clear evidence that manufacturing has been carried out in accordance with Good Manufacturing Practices standards. Consequently, all processes for trade harmonization aim to guarantee that all associates agree that they would apply the same Good Manufacturing Practice standards.

As a conclusion to this, a process for the harmonization of a manufacturing sites inspection system, through which adherence to GMP may be verified, should be implemented. As it will be seen later, this will be the basis of the WHO Quality Certificates for products under international trade.

GMP regulations neither dispute nor compete with the international efforts towards general quality harmonization which takes place based on the ISO systems, especially the 9000 series. GMPs are simply a specific development of quality assurance systems, within a specific production sector, with highly singular characteristics.