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What should a pharmaceutical manufacturer do when they receive a complaint about a potential quality defect in a medicine?

According to the EU Good Manufacturing Practice guidelines, the manufacturer must have a system and written procedures in place to record, assess, investigate, and review all complaints.

When a complaint is received, they must document the original details and use Quality Risk Management principles to assess the validity and extent of the defect.

Additionally, special attention must be given to establishing whether the suspected quality defect relates to falsification (counterfeit medicines).

EudraLex Vol. 4, Part 1, Chapter 8: Complaints, Quality Defects and Product Recalls

If the investigation confirms that the defect is real and poses a significant risk, do they need to notify anyone outside the company?

Yes, absolutely. The guidelines state that quality defects must be reported to the marketing authorisation holder (or sponsor) and all concerned Competent Authorities in a "timely manner".

This notification is specifically required in cases where the quality defect might result in a recall of the product or cause an abnormal restriction in the product's supply.

EudraLex Vol. 4, Part 1, Chapter 8: Complaints, Quality Defects and Product Recalls

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