FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality

Quality System Deficiencies Dominate MHRA’s GDP Deficiency Report

Jan. 4, 2018
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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.

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