Quality System Deficiencies Dominate MHRA’s GDP Report

January 5, 2018

Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency.

Quality issues accounted for 22 percent of deficiencies, followed by transportation deficiencies at 13 percent and responsible person deficiencies at 12 percent.

The other major GDP deficiency categories were supplier qualification (10%), equipment (9%), documentation (9%), temperature control (9%), storage (5%), and customer qualification (5%).

Quality system issues were the most numerous quality management deficiencies, with 32 recorded. The second most frequent deficiencies observed were management review and monitoring and quality risk management.

The agency also cited management deficiencies, such as evidence of deviation reports being closed without an adequate CAPA being implemented. In addition, some risk-based activities were incompletely recorded or not logged at all.

The MHRA did not include a comparison between inspection years 2016 and 2015 because of changes in GDP regulatory requirements over the period, noting that any identified trends could be misleading until after a full annual inspection cycle.