Update to EU GMP Part I Chapter 8: Complaints, Quality Defects & Recalls הדפסה
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שלישי, 23 ספטמבר 2014 20:46



The new update to chapter 8 of the EU GMP will come into operation on  March 1st 2015. This chapter deals with Complaints, Quality Defects and Product Recalls.


It explains about personnel and organization, procedures for handling and investigating complaints, decision-making, Root Cause Analysis and Corrective and Preventative Actions (CAPAs), and product recalls and other potential risk-reducing actions.


The chapter was extensively revised and here are some of the changes:


* Quality Risk Management (QRM) principles should be applied when investigating quality defects or complaints, and when making decisions in relation to product risk-reducing actions (such as a recall or a cautionary communications to healthcare professionals). For example, the assessment of the risk posed by the quality defect need to be based on the severity and the extent of the quality defect.


* The Qualified Person (QP) should be made formally aware of any investigations and any risk-reducing actions in a timely manner.


* For the handling, assessment, investigation and review of complaints and quality defects and for implementing any risk-reducing actions, inter-disciplinary teams should be considered, including appropriately trained Quality Management personnel.


* The manufacturer should handle differently quality defects complaints and adverse events complaints.


* Any quality defect investigation must include the identification of the potential Root Cause(s) of the quality defect.


* A human error is usually not the Root Cause of a defect.


* If a product quality defect is discovered or suspected, the company should consider checking other products as well.


* The decision of a recall should take into account the availability of the medicinal product to patients.


* The Competent Authorities should also be informed in situations in which no recall action is being proposed for a defective batch, because the batch has expired.



In the file attached, the sentences which have been omitted from this revision are in red, and the new ones are in green.

עדכון אחרון ב-שלישי, 23 ספטמבר 2014 23:43