Services for Pharma and Life-Science

 

 

GxP Compliance

 

GxP stands for the classical quality management (QM) systems in the fields of pharmaceutical, chemical, biotechnology, food (USA) and medical devices industry and their suppliers and contractors.

Study-oriented Systems

GCP       Good Clinical Practice
GLP        Good Laboratory Practice

Batch-oriented System

GDP      Good Distribution Practice
GMP      Good Manufacturing Practice

The following "quality scale" shows that negative influences such as variations, modifications, OOS, audit observations or complaints can be balanced by the counterweight CAPA.

Quality Balance

Please move your mouse into the area of ​​the figure. As you can see,
the system remains in balance only if you pay attention.

 

In all quality systems a state is desired where the quality events are in balance and the company meets the regulatory requirements steadily. The reality shows that quality differences are common. Thus a central demand of the authorities is to detect deviations systematically, collect, evaluate, communicate, control them by suitable measures and eliminate their reoccurence permanently.

In the GxP environment this tool is called CAPA "Preventive And Corrective Action" system. We consider this system as the most effective tool of quality professionals in the regulated industry. Thus, the corrective and preventive measures, are the most important points to make in a company demonstrating a experienced quality system, that is transparent and feasible.

From our experience across cultures, we have identified the main factors that influence compliance negatively in a company. Thus quality improvements consist of many small units, and the ability to integrate them into the so-called "daily business". We support the introduction and design of quality measures in your company or you mandate us to analyze an existing system, to adapt and optimize it finally.