COMPLAINTS AND RECALLS of Drugs QA .pptx

Complaints and recalls of pharmaceuticals

1. COMPLAINTS AND PRODUCT RECALLS Benedicta Adade Mawunyo

2. COMPLAINTS

3. COMPLAINTS Complaints: Any communication received from regulatory bodies about the quality of a pharmaceutical product. A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her.

4. COMPLAINTS Special attention should be given to establishing that the product that gave rise to a complaint was defective. Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated.

5. COMPLAINTS If a product defect is found or suspected, consider checking other batches to see if they are affected. Complaints records should be regularly reviewed. Appropriate follow-up action should be taken, possibly including product recall.

6. PRODUCT RECALL Product recall: refers to the process of retrieving or correcting products that have been found to be defective, unsafe or non-compliant with quality standards after they have been released into the market.

7. CLASSIFICATION OF RECALLS Class 1: Involves products that pose a serious health risk or death. Examples: contaminated products or non sterile injections . Class 2: Involves products that may cause temporary health problems or pose a slight threat. Example: Mislabeling, missing or incorrect information (leaflets or inserts). Class 3: Involves products that are unlikely to cause any adverse health reaction but violate FDA labeling/manufacturing. Example: Wrong or missing batch number or expiry date.

8. PRODUCT RECALLS HANDLING An authorized person should be responsible for the execution and coordination of recalls. The organization should have a clear and documented procedures in place for recalling products.

9. PRODUCT RECALLS HANDLING An instruction should be included in the written procedures to store recalled products in a secure segregated area. The effectiveness of the arrangements for recalls should be tested and evaluated from time to time.

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