Complaints and Recalls

1. Complaints and Recalls Prepared by: Paras J Shah M.Pharm – sem 1 Quality Assurance Guided by: Dhaval sir Smt.R.D.Gardi B.Pharmacy Collage Rajkot

2. Some complaints have attempted to increase the amt of feedback.Toll free no- positive suggestions forr impruvements. • Evalution of pdt: information on the potencial problem. Complain handling system step 1 Receiving complants step 2 Technical investigation step 3 corrective action and feed back to customers step 4 monthly report and trend analysis

3. Recall : A firm removal or correction of marketed product that FDA considers to be in violation of laws it administers and against which agency would initiate legal action.

4. Handling Of Returned Drug & Reprocessing • An examination of the reasons for return in order to decide whether further action is required on the lot or to the storage and distribution chain. • If the goods are found in normal range of condition it will be redistribute after visual examination. Or if not found then return to stock as is or after reprocessing after appropriate evaluation. • Maintain full comprehensive records to allow identification of returned good distribution and accountability in event of recall. • To remove from commerce portions of a lot which may have been adversly affected.

5. Recall Procedure • Responsibility: • The general manager (the highest person in management) has the ultimate responsibility to direct the prompt of defective / recalled from market. • Product recall management: • Procedure should settle a center to collect and store all returned stocks of the recalled product. • All needed data quality and nature of product shall be noted down by this center as records. • Fate of Product recall: • All records and information on the returned will be collected for evaluation purpose • That’s report presented to the Product Recall committee and the fate of the product shall be determined. • The final recall report • Final recall report a written evaluation summarizing the circumstances leading to the recall, corrective action taken and the disposition of the recalled product by the recall team once the recall considered closed.

6. Documentation • Quality control department is responsible to keep in recall file. • This files will retained for at least one year after the expiration date of the recall lot. Recall Completed: For monitoring purpose, FDA classifies recall action “completed” when all outstanding product, which reasonably be expected is recovered or corrected.

7. Thank you