MHRA new guidance for industry on GMP data integrity definitions

MHRA announced its guidance for industry on GMP data integrity definitions on January, 2015. Data integrity requirements apply to both manual (paper) and electronic data equally. While using data integrity guidance EU GMP, and national medicines legislation and the GMP standards published in Eudralex volume 4 should also be reviewed as they are complementary to each other. Manufacturers and analytical laboratories should be aware that while reverting from automated / computerized to manual / paper-based systems manufacturers and analytical laboratories should keep in mind that they will not in itself remove the need for data integrity controls. If they remove it by their own then this may constitute a failure to comply with Article 23 of Directive 2001/83/EC, which requires an authorisation holder to take account of scientific and technical progress and enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.

This guidance gives information about MHRA expectations from pharmaceutical industry for data governance system. MHRA do not expect any forensic approach to data checking but it is expected that a system should be developed and run which gives an acceptable state of control based on the data integrity risk. This system should be fully documented with supporting rationale.

You can view the full guidance Click here.