MHRA Investigates GMP Deficiency Trends From 2016
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016.
Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections.
But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, production, complaints and recall and qualification/validation deficiencies also moved up the ranking list between 2015 and 2016.
The 100-page report offers examples of deficiencies related to corrective and preventive actions (CAPAs), staff training, a lack of senior management oversight of pharmaceutical quality systems, equipment issues, temperature-controlled storage facilities, and document control and completion, among others.
Among the most egregious examples, MHRA points to at least eight CAPAs that were overdue between 59 days and 242 days and were closed the day before MHRA’s inspection, as well as one company’s offering up fictitious utility monitoring data.
Tracking regulatory updates was another area of concern for MHRA, which noted in one case "no mechanism to ensure that changes to regulatory requirements were captured and the impact to the site considered," while in another, there was "no formal system for the review, assessment and where appropriate, implementation of EU GMP updates."
The report also features examples of deficiencies related to quality control laboratories, out-of-specification investigations, the handling of complaints and product recalls, and increased risks of microbial contamination.