STANDARD OPERATING PROCEDURE FOR MARKET COMPLAINTS

1.      Purpose:

1.1.The purpose of this SOP is to describe the procedure for handling of market complaints of products.

2.      Scope:

2.1.It is applicable to Quality Assurance department.

3.      Definition:-

3.1. Complaint is defined as statement that is something wrong or not good enough, which shows customer dissatisfaction about the company and product.

4.      Responsibility:-

4.1.Quality assurance Manager

4.2.Quality Control Manager

4.3.Production Manager

5.      Classification of complaint:-

5.1.            Packaging material Quality: - It is regarding packaging material or damage, as improper sealing of ampoule and color variation in packing material.

5.2.            Product Quality: - It is regarding discrepancies in product Quality.

5.3.            Shortage in packing procedure:-It is regarding the shortage in packaging procedure as one tablet in blister is missing; coding mistakes on label or unit cartons. Unit cartons, labels or d-slips is missing or not comply with relevant product.

6.      Time Period for investigation

6.1.            Investigation shall be completed within two weeks.

7.      Duration of complaint Record maintained:-

7.1.   Complaint record shall be maintained at least one year after expiration date of product.

8.      Types of Complaints:-

8.1.   Confirmed complaints:-

8.1.1.      When both complaints and retained samples showed out of specifications results or when only the complaint sample showed OOS results.

8.2.   Non-confirmed complaints:-

8.2.1.      When both complaint and retained samples showed in compliance with specifications or when only the complaint sample show OOS results.

8.3.   Counterfeit/Tamper Suspicion:-

8.3.1.      When the retain sample is within the specification and complaint sample is clearly OOS with no reason for that such as tampered drug product.

9.0.Procedure:

9.1.Any complaint, written or verbal, received directly from customer, retailer, distributor, marketing department, field staff or Government authorities regarding product quality, packing defects or shortages in packing procedure. Such complaints shall be considered as market complaint.

9.2.All such Complaints shall be sent to Q.A manager for investigation.

9.3.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 detail and sample of complaint products as an Annex I of this SOP.

9.4. On receipt of complaint the Q.A manager shall keep in record and enter in the complaint register as in Annex II of this SOP.

9.5. The Q.A manager shall investigate the nature of complaint.

9.6. Following procedure would be followed by QA manager for starting the investigation of Complaint.

9.6.1.      Photocopy of original complaint along with the sample should be sent to respective department head.

9.6.2.      The department head (Q.C / Production) shall check analysis, production and packing records for that batch as per the nature of the complaint and forward report to Q.A manager as in Annex III & Annex IV for necessary action.

9.7.      If the complaint is regarding the product quality or laboratory analysis then QA and QC managers shall carry out detailed investigation , check the retain sample of same batch, and shall get the retain sample and complaint sample re-analyzed using an approved method for routine testing of the product and compare the results.

9.8.      If the complaint is regarding manufacturing procedure then Q.A manager should recheck the BMR of that batch and also preceding and succeeding batch to confirm that the operation of manufacturing and packing was performed as per SOP & GMP norms as a part of investigation.

9.9.      On the completion of the investigation the quality assurance manager shall discuss his finding with managing director and make the decision that product is necessary for Recall or not.

9.10.  Investigation shall be completed within 2 weeks and should be taken up in the format for market complaint investigation report as in Annex V of this SOP.

9.11.  If required in the meantime an interim may be sent to complainant.

9.12.  A written reply shall be sent to respective agency about the finding and necessary action taken.

9.13.  A review of such complaint where drug deficiency/below standard ingredient is involved shall be carried out by the managing director, production manager, QC manager and QA manager and plan shall be designed to avoid any recurrence of such complaints.

10.        Attached Documents:

10.1.QC Investigation report

10.2.Production Investigation

10.3.Complaint No. Form

10.4.Data Sheet

10.5.Investigation report