British inspectors when inspecting drug manufacturers will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments, according to a “frequently asked questions” (FAQ) document recently-published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The FAQ is comprised of a set of 16 probing questions into how the EU will be evaluating and enforcing quality risk management (QRM) under the new QbD/ICH Q8-10 regulatory paradigm.
The FAQ states that drug firms should “embody” quality risk management as per the EU GMPs Chapter 1. This includes having a standard operating procedure (SOP) in place that is integrated with the quality system, defines how the firm’s QRM system operates and includes a periodic review. The SOP should include scope, responsibilities, controls, approvals, management systems, applicability and exclusions.
MHRA expects risk mitigation plans to be identified and implemented where any risk to patient safety is possible, and notes that the degree of risk tolerated depends on the circumstances, proximity to the patient, and other controls in place prior to product use by the patient.