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Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects

Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use" last week (04 May, 2023), which covers the requirements for investigating and reporting to the HPRA quality defects.

A quality defect in a medicinal product may be defined as an attribute of a medicinal product, or component, affecting the quality, safety and/or efficacy of the product, and/or which is not in line with the approved product authorisation (PA), veterinary product authorisation (VPA), or other marketing authorisation.

A key objective of this guidance is to provide additional guidance to stakeholders in addition to that contained in the legislation so that stakeholders are able to

(i) Report and investigate potential quality defects appropriately and in the required timeframes, to mitigate risk to patients or animals.

(ii) Apply requisite oversight to defect issues, commensurate with the level of risk posed.

(iii) Carry out detailed root cause analysis (RCA) investigations to ensure appropriate corrective and preventive actions are implemented, to prevent recurrence of issues leading to the quality defect.

This guide covers the requirements for investigating and reporting to the HPRA quality defects in human and veterinary medicinal products. As per EU GMP Guidelines Chapter 8 (Complaints and Product Recalls), the HPRA should be notified immediately of any potential quality defect that may result in market actions or abnormal restrictions in supply.

All reportable defects should be notified to the HPRA as soon as possible, regardless of risk.

  • High risk (critical) and moderate risk (major) defect issues should be reported immediately (maximum three days).

  • Low risk (minor) or moderate risk (major) issues where there is no proposed market action should be reported to the HPRA in a timely manner (moderate risk – maximum five working days, low risk - maximum ten working days).

To know more about the Classification of quality defects, Report requirements and Required format for quality defect investigation reports click this LINK.


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