SOP for Handling of Market Complaints : Pharmaguideline

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SOP for Handling of Market Complaints

Standard operating procedure to handle the market complaints received from market.

1.0 Purpose:

To lay down a procedure for handling of market complaints.

2.0 Scope:

This procedure is applicable to all Market Complaints.

3.0  Responsibility:

Marketing Department         
Forwarding the complaints to QA. (If any)

Coordination for handling of complaints.
Quality Assurance Executive/ Designee
Logging of Complaint received from marketing department, customer (if any).
Assigning a number to the complaint.
Distribution to concerned departments

Maintaining records. Preparation of investigation report.
In-charge Production   
Investigation of complaint / Preparation of investigation report.
Training to the concerned person whenever required.
Implementation of the corrective action.
In-charge QC  
Analysis of the complaint sample whenever required.
In-charge QA  
Investigation of complaint
Suggesting corrective actions.
Ensuring implementation of corrective action.
Training to the concerned person whenever required.
Reply of the complaint based on the investigation report.
Head  Pharma Research /RA
Recommendation of any change in process, if required.
Regulatory Affairs               
Forwarding of investigation report to Regulatory Authorities/Customer (In case of Export only).   
Plant Head
Suggesting  Corrective and Preventive action.
Ensure implementation of the corrective action.
Site- Head Quality       
Review and approval of investigation report.
Suggesting Corrective and Preventive action.
Periodic review of the complaints.

4.0  Procedure :

4.1  Product complaint received serves as an indicator of product quality and potential source of danger or concern following distribution for sale. Therefore, as GMP each complaint or inquiry either oral or written is to be evaluated as per this SOP.
4.2  All the product complaints are to be promptly forwarded to QA department. If complaints are forwarded to Site-Head Quality then he has to forward the complaint to QA department for investigation.
4.3  The originator has to provide full details of complaint in prescribed format (as shown in annexure I) and to be send to QA department along with preferably complaint sample.
4.4  Complaints received from Drug regulatory authorities are to attend and evaluated as per the directives received form them.
4.5  Upon receipt of complaint at Quality Assurance department, QA personnel have to enter  the Complaint in the Market complaint register (as per the Annexure 2). Register consists of details as mentioned below
4.5.1  Sr.No.
4.5.2  Date of receipt
4.5.3  Complaint Reference
4.5.4  Complainant
4.5.5  Details of complaint (Product Name, Batch No., Quantity of sample & relevant information)
4.5.6  Nature of Complaint (To be filled during investigation)
4.5.7  Corrective Action (To be filled after investigation)
4.5.8  Preventive Action (To be filled after investigation)
4.5.9  Remarks :Reply Date (To be filled after investigation)
4.6  Serial No. in the register is to be entered as Sr. No. / Year. (e.g. 01/2005 Where 01 indicates first number of complaint received and recorded in year 2005 This complaint log will exist up to 31st December of the same commercial year.
4.7  QA department has to formalize and investigate any verbal complaint from Drug Authority / Regulatory Authority /Actual User / Physician / Pharmacist.
4.8  After logging of complaint, QA department has to start the investigation of complaint. QA department has to ,Check the nature of the Complaint, verify the complaint sample if available or control sample & on the basis of initial investigation categorize the complaints into Critical / Major / Minor.
Complaints related to defective/ dangerous/ Potentially life- threatening medicines that predictably or probably could result in to serious health Risk /adverse events or even death. For Example (But not limited to):
Wrong Product (Label and contents are different),
Correct product but wrong strength, with serious medical consequences, Wrong active ingredient in a multi-component product, Mix-ups of some products.
Complaints that could cause illness or mistreatment, but are not critical.
For example (but not limited to):           
Mislabeling (Wrong or missing text or figures)
Missing or incorrect information (leaflets or inserts)
Chemical /Physical contamination
Non-Compliance with specification
Complaint which may not pose a significant hazard to health, complaints due to secondary packing materials, Shortage complaints, Damage of containers. 
4.9  If the initial investigation indicates that the complaint is of critical, intimate to the Marketing Department (as per the format shown in Annexure – 3) for the stoppage of further sale and distribution within 24 hours from the receipt of communication.
4.10  Communicate to drug liaison, regulatory affairs and client/ customer regarding market complaint based on nature of market complaint (if required).

4.11  Record the observations (i.e. Critical/Major/Minor) in the Record for Market Complaint and start the complete investigation.
4.12  In case of quality related complaint, send the complaint sample if available (or sample from control sample) to Quality Control for analysis. Depending on the nature of complaint the control sample and complaint sample (if any) is to be analyzed for the relevant test parameters. Analysis of the sample is to be carried out as per the specification by which the product was initially released.
4.13  Test parameters to be performed for the complaint sample are to be specified by Site-Head Quality or his authorized nominee. After completion of analysis, QC has to send the report of Analysis to QA for further investigation. 
4.14  QA department has to consult (as per requirement) with Pharma Research/ ADL / Marketing/ Production for necessary investigation at their end. Appropriate action is to be chosen from the following ,depending on the nature of the complaint:
4.14.1  Observation and analysis of complaint sample and packing slip (if any)
4.14.2  Observation and analysis of retained sample of the same batch or other batches of same product.
4.14.3  Comparison of results of above.
4.14.4  Review of Product specification, Batch manufacturing record, batch analytical records.
4.14.5  Facility or equipment problem
4.14.6  Training records of concerned operators staff and identify the training needs if any
4.14.7  Trend analysis, Stability data, process validation report, product development report. Based on the observations, identify the root cause of the incidence.
4.14.8  Review of Control sample of ± three Batch Nos. from market complaint Batch
4.15  Take Medical opinion (if any) from medical experts with concern patient (if any) as a part of investigation.
4.16  Prepare an investigation report as per the Annexure 4 ( if require additional sheets are to be enclosed.)
4.17  Mention all the corrective and preventive actions in detail & target date for the completion of the corrective action in the investigation report. Forward it to the Plant Head &Site-Head Quality for review.
4.18  Prepare a reply based on the complete investigation.
4.19  Forward the  duly filled complete investigation details to Marketing department along with the reply letter mentioning the corrective and preventive actions taken to avoid future recurrence of the incidence ( In case of  Domestic complaint ) and  forward the same to RA ( In case of export complaint). 
4.20  As a part of investigation, the need for recalling the batch is to be decided by Site-Head Quality depending on the nature of the complaint. In such cases the SOP for Product Recall is to be followed. 

4.21  Initial response shall be sent to Marketing department within 7 days for domestic complaints and 10 days in case of Export complaints.
4.22  Marketing Department /RA department has to forward the Reply to the customer with a copy of same to QA department.
4.23  Feedback from the customer/complainant on the reply is to be taken. Feedbacks (if any) received from the customers/complainant are to be forwarded to QA department for records.
4.24  The complaint shall be treated as “Closed” after receiving feedback from the customer. The time period for receiving feedback from the customer is:
4.24.1  Customer feedback from Domestic Market within 3 weeks.
4.24.2  Customer feedback from International Market within 4 weeks.
If feedback is not received within the stipulated time, the complaint shall be treated as closed.
4.25  Review the customer complaint status and customer complaints every quarter to evaluate specific or recurring problems which require further attention.
4.25  Maintain all the records involving market complaints handling till one year after the Date of expiry of the product or one year after the date of complaint received whichever is longer.

5.0  Annexures:

Annexure 1             :           Record for market complaint
Annexure 2             :           Market complaint register
Annexure 3             :           Intimation to Marketing Department
Annexure 4             :           Investigation of complaint
Annexure 5             :           Flow for handling of market complaints
Annexure 6             :           Distribution list

6.0  Abbreviation:

6.1  SOP - Standard Operating Procedure

Annexure 1
Record for Market Complaint
 To be filled by Domestic/International Marketing/Originator :
Date:                                                                                     Date of Receipt of Complaint                                                 
Complaint Details :
Letter Reference(if any):
Name and Address of complainant:
Complaint From :
Complaint Received Through :
Name of Product :                                                                  Batch No :
Mfg. Date            :                                                                  Exp. Date :
Nature of Complaint :                                                   

Total Quantity of Complaint Sample:                              Sign: Domestic/ International Marketing/


Investigation Details :
To be Filled by QA :                                                          Complaint No: 
Name of Product :                                                                  Batch No :
Mfg. Date            :                                                                  Exp. Date :
Dosage form:
Marketing Authorisation Number/ Mfg. Lic. Number:
Nature of Complaint :  Critical / Major / Minor

Physical description of the Complaint Sample :
Review & Investigation by Q.A.
                                                                                                               Sign / Date:  ( QA In-charge )
Review & Investigation By Q.C.:

Report of Analysis (if any):                                                                    Sign / Date:  ( QC In-charge )
Review & Investigation By Production :

                                                                                                Sign / Date:  ( Production In-charge )

Review & Investigation By Pharma Research / ADL :                                                  
                                                                                                                                Sign / Date :
Review & Investigation By Marketing  :
                                                                                                                                Sign / Date :
Corrective and preventive action taken :

                                                                                                             QA department (Sign / Date)
Reviewed By :

                                                                                                           Site-Head Quality (Sign / Date)
Forward to RA/Marketing in case of Export/Domestic complaint respectively :

Reply Ref:
                                                                                                                         Head - RA ( Sign / Date )

Annexure 2
Market Complaint Register
   Left hand side of register
Complaint Reference & Date
Product Details
Details of Complaint
   Right hand side of register
Nature of Complaint  (Critical / Major / Minor )
Corrective action
Preventive Action taken

Annexure 3
Intimation to Marketing Department

Head – Marketing Department,

C. C.: V. P. (Quality & Regulatory), V. P. (Manufacturing). V. P. (Sale & Distribution), CMD Office
Subject: Immediate stoppage of sale and further distribution of the product.
With respect to market complaint received by us, you are requested to stop the further distribution and sale of the following product.
Product Name:
Batch No.
Mfg. Date:
Exp. Date:

Site Head Quality.

Annexure 4
   Investigation of Complaint
Party Ref. No :
Complaint From :
Date of Receipt :
ID No :
Product's Name :
Batch No :
Initiated on :
Completed on :
Sign QA :

1.  Incidence :
1.1.  Interpretation :
2.  Scientific or Practical Reason :
3.  Identification of Real Problem / Area :
4.  Responsible for Activity :
5.  Reviewed By :
5.1  Production Dept. :
5.2  In charge -  Q. A. :
5.3  QC in-charge :
5.4  Warehouse In-charge :
5.5  Pharma Research / ADL / RA / PD ( If required )
Corrective Action

Preventive Action:
                                                             Plant Head (Sign. & Date)
                                                             Head Quality (Sign. & Date)
Attach Extra Sheet for the Action Plan & Target dates, if Necessary
Production  In-charge

QA Incharge

Plant Manager  

Head Quality 

Annexure 6
Sr. No.
Name of Department
Quality Assurance
Quality Control
Regulatory Affairs
Pharma Research
Development Quality Assurance (Formulations)
Corporate Quality Assurance

Annexure 7

Reason for Revision
Change Control No.

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