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Standard Operating Procedure (SOP) & Guideline for Handling of Market Complaint of Drug Product. 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.

Handling of Market Complaint

1.0   Objective :

• To lay down the procedure for investigation and reporting of market complaint to generate appropriate response based on the conclusions drawn from the investigation.

2.0   Scope :

• This SOP is applicable to all Market Complaint received at pharmaceuticals drug manufacturing plant.

3.0   Responsibility :

• Head Quality Assurance / Designee, Head Quality Control / Designee & Head Production / Designee.

4.0   Procedure for Handling of Market Complaint :

• Market Complaint shall be categorized as

• Minor Market Complaints:

• Complaints those are related to but not limited to:
  • Physical damage to containers.
  • Shortages / short supply.
  • Poor presentation of product container.

• Major Market Complaints :

• Complaints those are related to but not limited to:
  • Chemical / Physical attribute of the product.
  • Complaints related to Stability.
  • Un-coded or wrongly coded product, Batch No.
  • Mixing of Carton, PP Cap & Literature.

• Critical Market Complaints

• Complaints those are related to but not limited to:
  • Adverse reaction leading to permanent damage/impairment or even death.
  • In case Change in organoleptic properties, Discoloration of product.
  • Incorrect Manufacturing or Expiry dates, Label & Printed Foil, Product mix-ups, Batch mix-ups etc.
  • Significant drop from reported assay value, abnormal impurity levels.

• Handling of Market complaint (s) :

  • Any Market complaint received shall be sent to the Head – QA.
  • Complaints can be reported through verbal communications, fax or any mail forms.
  • The complaint shall be acknowledged by Head QA / designee through Email / letter within three working days and record shall be kept along with Market complaint investigation form.
  • After receipt the market complaint Head QA / Designee shall record the details in Annexure-II “Market Complaint Log” and Annexure-I “Market Complaint Investigation Form” within 24 hour.
  • On receipt of the complaint, Head – QA shall request the complainant to send the complaint sample (if the sample is not received) for better investigation. Also ask the extent of quality defect.
  • Head – QA shall discuss all the complaints with the Production Head and QC Head.
  • On receipt of complaint sample, Head QA/Designee shall compare the sample received with the control sample to check for any counterfeit and shall record in “Market Complaint Investigation Form” as per Annexure-I.

  • Investigation of Market Complaint :

  • If the complaint sample confirms counterfeit, Head QA/Designee shall record the details of investigation carried out in Annexure-I and inform the details to the complainant and the legal advisor.
  • If the complaint sample does not confirm for any counterfeit, continue the investigation to find the root cause for effective CAPA following  “Corrective and preventive action”.
  • Head QA on consultation with Production Head and QC Head shall classify the complaint as Major/Minor or Critical and shall depute his designee for further investigations.
  • Head QA shall do the risk assessment posed by quality defect, based on severity and extent of quality defect following SOP for “Quality Risk Management”.
  • QA shall assess the impact of the complaint sample on the other batches and also for other products by comparing the control samples and based on the impact assessment investigation shall be extended to impacted batches.

  • Head QA shall review the investigation report.

  • If required analysis of the complaint sample shall be carried out to investigate the complaint.
  • The results obtained shall be evaluated and if the data indicates variance with initial COA value, the differences observed shall be recorded in the “Market Complaint Investigation Form” as per Annexure-I.
  • If required the Head QA/Designee shall seek additional information from the customer vis-a-vis methods, sample handling, storage etc. through the Marketing Head.
  • If the analysis reveals any stability related problems, Head QA/Designee shall investigate batch history, storage and distribution.
  • Head QA/Designee and Production Head shall review various records/documents during investigation. These may include executed BMR/BPR, analytical test records, sampling and release records, batch distribution record and other processing records.
  • Head QA/Designee shall share the findings with the Production Head and QC Head.
  • QA Head /Designee shall summaries his findings after discussing with Production Head and QC Head.

  • Head QA shall review the summary report in Annexure-I with comments.

  • Based on the complaint review outcomes, CAPA shall be planned and shared to domestic and international customers.
  • If required recall shall be done following SOP for “Recall of Product from Market”:
  • Designee QA shall record summary of findings in ‘Market Complaints Records’ as per Annexure-II.
  • Investigate the root cause for Critical Complaint within 10 working days and for Minor/Major Complaint complete within 30 working days.
  • Provide the CAPA response to the customer.
  • If there is no further query received from the complainant on respective complaint response in next 15 days then complaint shall be considered as closed.
  • Head-QA/Designee shall ensure all quality related complaints taken to their logical conclusion.
  • Head QA/Designee shall monitor the corrective actions taken and ensure closure of complaints.
  • Monitor the reoccurrence for the nature of complaint continuously.
  • Share the complaint with concerned regulatory authority (ies)
  • Refer flow chart for better understanding of SOP.

• Preservation of records

  • The records shall be preserved with QA department for perpetual.

• Procedure for Numbering of Market Complaint Investigation Form

  • The Market Complaint Investigation Form shall be numbered as. MC/YY/ZZZ
  • Where,
  • MC                  :           Market Complaints.
  • XX                   :           Stands for last two digit of the calendar year
  • ZZZ                 :           Indicates serial number.

• Trending of Market complaint:

• Carryout the Continuous trending of the market complaint.
• QA shall carry out the trend analysis for whole year at the beginning of the next year.
• Forward a copy of trend analysis to Head QA.
• Carryout the trending for the market complaint; as minor, major and critical complaints.
• However the trending like Shortages / short supply, Quality related complaint, adverse reaction leading to permanent damage/impairment or even death etc.

5.0   Reference (S) :

• Revised Schedule M
• Volume 4:   EU Guidelines to Good Manufacturing Practice Medicinal Products for
  Human and Veterinary Use, Chapter 8 Complaints, Quality defects and product Recalls
• PIC/S “Guide to Good Manufacturing Practice for Medicinal Products Part I.

6.0   Annexure (S) :

Annexure – I : Market Complaint Investigation Form.

Annexure – II  : Market Complaint Log Record.

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