1. Any complaint, written or verbal, received directly from the 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 the complaint.
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 the investigation.
9. On the completion of the investigation, the quality assurance in-charge shall discuss his finding with plant in-charge / Technical director
10. The investigation shall be completed within 3 weeks and should be taken up in the format for market complaint investigation report.
12. A written reply shall be sent to the 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.
Also see: Requirements for Good Documentation Practice (GDP)
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 the complaint.
- Product Name:
- Batch No.:
- Mfg date & Exp. Date:
- Nature of Complaint:
- 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
- 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.
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 the investigation.
9. On the completion of the investigation, the quality assurance in-charge shall discuss his finding with plant in-charge / Technical director
10. The investigation shall be completed within 3 weeks and should be taken up in the format for market complaint investigation report.
12. A written reply shall be sent to the 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.
Also see: Requirements for Good Documentation Practice (GDP)
please give the formates for the same format
ReplyDeleteplease give the stability storage condition according to zones...
ReplyDeleteKindly provide the reference to guidelines and necessity of the requirements.
ReplyDeleteHello sir, The procedure looks excellent, very simple and easy to understand.
ReplyDeleteAlso it is suggested to incorporate the immediate action needs to be taken in case of any critical complaints in order to avoid the usage of the product by patients until the complaint is resolved (if in case) / if any recalls to be initiated.
@ Rajesh Reddy.