UK Regulatory Agency Issues Trend Analysis on GMP Deficiencies


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-20-2017 14:25

  

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) released a new report on the trends from its inspection activity of dosage-form manufacturing plants and related GMP deficiencies in 2016. Quality systems and sterility assurance were leading areas for GMP deficiencies.

The report included data based on 324 inspections by the MHRA (242 inspections in the UK and 82 overseas). Among the most cited deficiency groups in 2016 were quality systems (1259 total deficiencies: 38 critical, 449 major, and 772 other); sterility assurance (386 total deficiences: 34 critical, 190 major, and 162 others); and production (754 total deficiencies: 20 critical, 191 major, and 543 other). In 2015, quality systems, complaints and recalls, and documentation led the most cited deficiency groups. Examples of deficiencies that the report provided included deficiencies related to corrective and preventative action (CAPA) implementation, lack of senior management oversight on implementing pharmaceutical quality systems, equipment, production, product quality review, failure to minimize contamination risk, temperature-controlled storage, and data integrity.

In some examples related to CAPA deficiencies, the report pointed out that at least eight overdue CAPA (ranging from 59 days to 242 days overdue) were observed to have been closed the day before inspection and that, in another instance, two overdue CAPA (186 days and 60 days overdue), remained open at the time of inspection. In another instance where 134 deviations were raised over the course of three months, no CAPA was raised.

In another example related to the lack of senior management oversight, the MHRA pointed out one instance where minutes from a meeting stated that all environmental monitoring results were satisfactory despite there being an obvious adverse trend increase in cleanroom environmental monitoring results. In another instance, monthly quality system metrics that were generated did not include the status of supplier audits and did not show site performance over time. This is needed to allow an effective review of performance changes and to confirm that the quality system is in a state of control, according to the MHRA.

Other examples of deficiencies that the MHRA covered include change control management, lack of regulatory update monitoring, document control and completion, activities of the quality control laboratory, out-of-specification and out-of-trend investigations, and management of outsourced activities, among others.

Source: Medicines & Healthcare products Regulatory Agency

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