MHRA develops a new blog on GMP Data integrity

MHRA has recently developed a new blog on GMP Data integrity in addition to the existing data integrity guideline by the MHRA. In total, there will be three blogs on this topic. The first blog has been online since 25th June 2015. MHRA considers this topic very important and emphasizes that this topic is not a new requirement, because the basic requirements for the integrity of data are already included in the international GMP regulations. The pharmaceutical companies are now required to implement appropriate measures and technical processes to significantly improve their systems.

According to the MHRA, the integrity of data in a pharmaceutical quality management system is so fundamental, because only this ensures that the medicinal products meet the required quality. MHRA's experience has shown that the majority of non-compliance cases have to do with bad practices, poor organizational management or with weak systems which open possibilities for data manipulations.