GxP-Blog

Good Manufacturing Practice in the Focus of International Bodies

GMP is GMP. Can this statement be correct? GMP, or Good Manufacturing Practice, summarizes guidelines that are to be applied for the manufacture and sales of medicinal products. Without adhering to the GMP regulations no pharmaceutical company can obtain a manufacturing authorization. This is regulated worldwide by laws, regulations and guidelines, which are issued by governments, ministries and international organizations. And this is exactly the critical issue: Although GMP guidelines are unified to a great extent, the interpretation of these guidelines varies worldwide and differs from country to country. If a local GMP certificate has been issued, it might be difficult to have it recognized by international bodies.

International, but also national and partly municipal health authorities can interpret the GMP guidelines in different ways and set different requirements for the manufacture of medicinal products. Therefore, also GMP inspections of local and international authorities can differ. Companies must abide by the regulations that are applicable in the country in which the medicinal products are manufactured. However, if such medicinal products are delivered from this location to other countries, then also the guidelines of the country to which products are delivered must be fulfilled.

Despite the aspired and partly implemented harmonization of the GMP regulations the differences are larger than realized in most organizations and in their management. This often leads to the consequence that the existence of a GMP certificate issued by a local authority is falsely thought to be equal to and guarantee the approval of an inspection performed by an international authority. This can in certain circumstances lead to a rude awakening: it is exactly over the previous years that German and European pharmaceutical companies attracted the attention of the American Food and Drug Administration (FDA). So, there was an increase in inspections performed in Germany and Europe regarding the observance of the current Good Manufacturing Practice (cGMP). Noncompliance with the cGMPs have consequences and are at worst punished with the so-called "warning letters". In case of serious breaches, the responsible employees and executives can face criminal and civil liability suits. In order to avoid such experiences that can be both financially painful for a company, as well as harm its reputation, it is good to profit from the experience of others.

If a representative of the FDA performs a GMP audit, which is by authorities always referred to as inspection, both cultural as well as practical differences can be determined: An FDA auditor will always refer to himself as an «investigator» and not as an «inspector» and also performs his inspection in this way and this points to an important aspect that must be taken into account. No or only little preparation for such an inspection represents a high risk regarding the success of the inspection.

It is also an obligation to prepare oneself in a structured way for each «investigation» and to consider thereby all necessary aspects in each of the units involved in the inspection. These aspects include, apart from classical areas such as the plants and QM systems also the human factor. This refers to both the inspector as well as the employee in the company. In short: An expected visit from an inspection must be planned and organized in order to be successful. Therefore, it is crucial to deal very precisely with the GMP regulations of countries relevant for the company in order to face potential inspections without any worries.