27 October 2020
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.
In addition to the existing Data Integrity Guideline the MHRA has now developed a new blog because the authority considers this topic so important. In total, there will be three blogs on this topic. The first blog has been online since 25 June 2015.
In the last two years there have been many reports on the integrity of data in the pharmaceutical media. Authorities had to take action after there were corresponding failures at pharmaceutical companies, which resulted in the recall of products, supply shortages and in a tremendous damage of the affected companies' reputation.
The MHRA emphasises 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.
From the MHRA's perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. But the MHRA's experience has shown that the majority of cases has to do with bad practices, poor organisational management or with weak systems which open possibilities for data manipulations.
The pharmaceutical companies are now required to implement appropriate measures and technical processes to significantly improve their systems.
For more detailed information please see the full MHRA blog Good manufacturing practice (GMP) data integrity-a-new-look-at at old-topic-part-1.
Source: MHRA, UK