QUIZ - Product Quality Complaint Training

QUIZ - Product Quality Complaint Training

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Question 1/10

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A Product Quality Comlaint is a defect in a finished product . This defect may or may not be associated with a notification of pharmacovigilance (medicines), materiovigilance (medical devices), cosmetovigilance (cosmetics/cosmetic active ingredients), nutrivigilance (food supplements), or a medical information query.

Question 2/10

A Product Quality Complaint can be :

• Difficulty opening the packaging
• Defective sealing of primary packaging
• Missing or unreadable information (batch number, expiry date, data matrix)
• Suspected falsification
• Non-functional packaging component (e.g., broken pump)

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• Absence of a component (e.g., missing leaflet/pump on a Mustela product)
• Presence of another medication in the packaging
• Unusual appearance (e.g., broken tablet, phase-separated product)
• Presence of foreign bodies in the product
• Unusual smell or taste of a product

Question 3/10

Within 24 hours

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In case of Product Quality Complaint not related to a pharmacovigilance case on a drug marketed by Expanscience Laboratories :

Question 4/10

Collect, as far as possible, the following information from the complainant:

• Dosage
• Expiry date
• Description of the observed quality defect in the complainant's own words as detailed as possible
• Photos if available
• Complainant's contact details
• Request for the complainant to retain the product: this will allow dedicated teams to organize a return of the defective product to our premises for investigation/analysis

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• Exact product name
• Batch number

• Complainant's contact details

Question 5/10

Collect, as far as possible, the following information from the complainant:

• Dosage
• Expiry date
• Description of the observed quality defect in the complainant's own words as detailed as possible
• Photos if available
• Complainant's contact details
• Request for the complainant to retain the product: this will allow dedicated teams to organize a return of the defective product to our premises for investigation/analysis

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• Exact product name
• Batch number

• Complainant's contact details

Question 6/10

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Any Expanscience employee (headquarters and field) as well as subcontractors and service providers must sent Product Quality Complaint to the address reclamationqualite@expanscience.com within 24 hours.

Question 7/10

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A quality defect leading to a Product Quality Complaint can be detected at different levels :

Question 8/10

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This product is a cosmetic. The Product Quality Complaint is related to a case of cosmetovigilance, I will immediately forward to : and Quality Department Cosmetic Department after having collected from the complainant all the information related to this quality defect.

Question 9/10

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This Product is a pharmaceutical product. This is a pharmacovigilance case involving a quality defect in the tablets and an adverse effect (stomach pain).

Question 10/10

Based on the nature of the defect, its recurrence, and the risk a bacth recall can may be required. For pharmaceutical products and medical devices, quality defects with a potential public health impact must be reported to the ANSM. The final decision to recall a batch in France is the responsibility of the Responsible Pharmacist.

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