GMP: GMP Data Integrity: New MHRA Guideline

The MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self inspections. Now, a Guideline of the MHRA on data integrity was published in January 2015. According to the MHRA, data integrity in a pharmaceutical quality management system is fundamental to ensure that the medicinal products are of the quality required. The Guideline describes MHRA\'s expectations for data in the GMP environment of pharmaceutical companies. These requirements should complete the existing regulations from the EU GMP and Eurdralex Volume 4.