HANDLING OF MARKET COMPLAINTS

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.

3.0 RESPONSIBILITY

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

4.0 ACCOUNTABILITY

Head Quality is responsible for compliance of this SOP.

5.0 Procedure

Market Complaint shall be categorized as

5.1 Minor Complaints:

Complaints those are related to but not limited to:

Physical damage to containers.

Shortages / short supply.

Poor presentation of product container.

5.2 Major 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.

5.3 Critical 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.

5.4 Handling of complaints

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 and record shall be kept along with Market complaint investigation form. After receipt the market complaint Head QA / Designee shall record the details “Market Complaint Log” and “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”.If the complaint sample confirms counterfeit, Head QA/Designee shall record the details of investigation carried out 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 SOP N “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 “Quality Risk Management”. Head QA/Designee 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”.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, QC Head and Head Quality.Head QA/Designee shall summaries his findings after discussing with Production Head, QC Head and Head Quality.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 “Recall of Product from Market”:Designee QA shall record summary of findings in ‘Market Complaints Records’ .The complaint shall be considered closed after 30 working days, CAPA response shall be provided to the customer. Head-QA/Designee shall ensure all quality related complaints are taken to their logical conclusion. Head QA/Designee shall monitor the corrective actions taken and ensure closure of complaints.Reoccurrence for the nature of complaint shall be monitored continuously. The complaint shall be shared with concerned regulatory authority/DRA/PL / QP/ MA holder. Refer flow chart for better understanding of SOP.

5.5 Preservation of records

The records shall be preserved with QA department for perpetual.

5.6 Procedure for Numbering of Market Complaint Investigation Form

The Market Complaint Investigation Form shall be numbered as.

QA : Quality Assurance.

MC : Market Complaints.

ZZZ : Indicates serial number.

5.7 Trending of Market complaint:

Continuous trending of the market complaint shall be carried out.

QA shall carry out the trend analysis for whole year at the beginning of the next year. A copy of trend analysis shall be forwarded to Head Quality.

The trending shall be carried out for the market complaint; same shall be done as minor, major and critical complaints. However the trending shall be done, like Shortages / short supply, Quality related complaint, adverse reaction leading to permanent damage/impairment or even death etc.

6.0 TRAINING

Trainer : Head – Quality Assurance

Trainees : Staff of all the departments

7.0 DISTRIBUTION

Master Copy : Quality Assurance

Controlled Copy : Quality Assurance

8.0 ATTACHMENT

9.0 REFERENCES

10.0 ABBREVIATION

11.0 REVISION HISTORY OF CHANGE