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Handling of Pharmaceutical Market Complaints


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.
Product Name:
Batch No.:
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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shrikant patil said...

please give the formates for the same format

Mann Bamaniya said...

please give the stability storage condition according to zones...

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