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Learn how to handle the Market Complaints received from customers in Pharmaceuticals.
1 Any complaint, written or verbal, received directly from customer, retailer, distributor, field staff or any Government Agencies regarding purity, labeling defects, shortages etc. such complaints shall be considered as a market complaint.
2 All such complaints shall be sent to Q.A. Manager for investigation.
3 In case the market complaint is verbal the Q.A Manager shall immediately send verbal / written communication to the person whom such complaint is received for sending details of complaint.
4 On receipt of complaint the Q.A Manager shall enter details in the complaint register as in annex 1 of this SOP.
Mfg date & Exp. Date:
Nature of Complaint:
5 The Q.A Manager shall investigate the nature of complaint and classify the complaint according to following action points:-
It is regarding shortage or damage.
It is regarding discrepancies in Product Quality.
In case the complaint is regarding the shortage in packing procedure as in 5 should be followed by the Q.A. Manager
6 Following procedure would be followed by Q.A. Manager for starting the investigation of the complaint:
A Photocopy of original complaint along with the sample should be sent to respective Department head.
The department head (Q.A./ Q.C. / Production) shall check up Analysis, production and packaging records for that batch as per the nature of the complaint and report to Q.A. Manager for necessary action.
7 If the complaint is regarding the product quality the Q. A. Manager shall carry out detailed investigation, check the control sample of same batch and should get the product re-analyzed using an approved method used for routine testing of the product.
8 Also the Q.A. Manager should recheck the BMR/BPR of that batch & also preceding & succeeding batch to confirm that the operation of manufacturing & packaging were performed as per SOPs & GMP norms as a part of investigation.
.9 On the completion of the Investigation the quality assurance in-charge shall discuss his finding with plant in-charge / Technical director
10 Investigation shall be completed within 3 weeks and should be taken up in the format for market complaint investigation report as in Annex 2 of this SOP.
11 If required in the meantime an interim report may sent to complainant.
12 A written reply shall be sent to respective agency about the finding and necessary action to be taken.
13 A review of such complaint where drug deficiency / below standard ingredient is involved shall be carried out by the Technical Director, Production manager, Q.C. Manager & Q.A. Manager and plan shall be designed to avoid any recurrence of such complaints.
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