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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.

Write Your Valuable Comment Below ...

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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