Handling of Pharmaceutical Market Complaints : Pharmaceutical Guidelines

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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 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.

4. On receipt of the complaint the Q.A Manager shall enter following details in the complaint register.
  • Product Name:
  • Batch No.:
  • Mfg date & Exp. Date:
  • Nature of Complaint:
5. The Q.A Manager shall investigate the nature of the 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 a detailed investigation, check the control sample of the 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 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.

11. If required in the meantime an interim report may send to the complainant.
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)

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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3 comments: Post Yours! Read Comment Policy ▼

  1. please give the formates for the same format

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

  3. Kindly provide the reference to guidelines and necessity of the requirements.


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