Quality Systems Listed Most Cited Inspection Problem in UK Regulatory ReportBy
The UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s national regulatory authority, has published a report, MHRA GDP Inspection Deficiency Data 2016, to identify the severity and frequency of deficiencies associated with European Union good distribution practice (GDP) references and the high-impact and high-frequency issues.
The report listed quality system issues as the most commonly observed major deficiencies during GDP inspections. According to the MHRA, quality systems include the management of processes for procurement, holding, and the supply of medicinal products.
Some examples of quality management deficiencies in the report were: little or no evidence of the effective implementation of change control, risk management, deviation capture, corrective and preventive action (CAPA) reporting or management review.
In addition to quality systems, the following were also cited as areas of major GDP deficiencies (in order of frequency): (1) transportation; (2) responsible person; (3) supplier qualification; (4) equipment; (5) documentation; (6) temperature control; (6) storage; (7) customer qualification.
The report says the purpose of publishing the inspection deficiency data is to allow industry to perform its own assessment against the deficiency findings as part of self-inspection and continuous improvement activity.