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Handling of Customer Complaint_Dr.A.Amsavel

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Reference Guideline Definitions GMP Requirement: 21 CFR § 211.198 and ICH Q7 Procedure for Handling of Complaints Complaint Investigation Remedial action and CAPA Report preparation Response to customer Verification of CAPA effectiveness Review of Complaints

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HANDLING OF CUSTOMERS COMPLAINT Dr. A. Amsavel
OVERVIEW  Reference Guideline  Definitions  GMP Requirement: 21 CFR § 211.198 and ICH Q7  Procedure for Handling of Complaints  Complaint Investigation  Remedial action and CAPA  Report preparation  Response to customer  Verification of CAPA effectiveness  Review of Complaints
GUIDELINES/ REQUIREMENTS  21 CFR § 211.198 Complaint files.  Investigation according to 21 CFR § 211.192 Production record review & Record and Reports shall be available § 211.180(c).§ 211.180(c).  Field Alert Report Submission Questions and Answers Guidance for Industry July 2018  ICHQ7 GMP for API: Section -15 Complaints and Recalls
DEFINITION Correction: An action to eliminate a detected nonconformity. ie Remedial action, Reprocess, rework, or adjustment Corrective Action: The action taken to eliminate the causesCorrective Action: The action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence. Preventive Action: The action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence. 4
DEFINITION  Conforming: Fulfillment of a requirement. An expected observation, event or characteristic.  Nonconforming Material or Process (Discrepancy) : Any material or process that does not meet its required specifications or documented procedure.specifications or documented procedure.  Nonconformity: Non-fulfillment of a specified requirement. (Any material or process that does not meet its required specifications or documented procedure).  Complaint : Customer / consumer reporting on the product or service, due to non-confirming of product or process or service. It may be related to quality, packing, document, service, etc. 5
DEFINITION Field Alert Report (USFDA) Any incident that causes the drug product or its labeling to be mistaken for or applied to another article, bacterial contamination, a significant chemical, physical,bacterial contamination, a significant chemical, physical, or other change, deterioration in the distributed drug product, and failure of one or more distributed batches of the drug product to meet the specifications established in its application I
PURPOSE OF COMPLAINT HANDLING  To ensure the patient safety.  To meet Regulatory Requirement  To maintain cGMP To maintain relationship with customers To maintain relationship with customers  It is reputation of company  It is an opportunity to improve the quality of the product or service  To improve the business growth
21CFR § 211.198 COMPLAINT FILES  Procedures shall be established and followed for handling of all written and oral complaints regarding a drug product  Any complaint involving the possible failure of a drug product to meet any of its specifications need for an investigation in accordance with § 211.192.investigation in accordance with § 211.192.  Review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration
21CFR § 211.198- COMPLAINT FILES.  A written record of each complaint shall be maintained at the site and readily available for inspection  Written records related to complaint shall be maintained until at least 1 year after the expiration date of the druguntil at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer.  For OTC drug products records shall be maintained for 3 years after distribution of the drug product.
21CFR § 211.198- COMPLAINT FILES  Record shall include the following information, the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant.  Record of Investigation conducted, and findings and Record of Investigation conducted, and findings and follow-up.  The record of the investigation shall be maintained  If investigation is not conducted, record the reason for an investigation was not necessary and the name of the responsible person making such a determination.
ICH Q7: 15.0 COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated Complaint records should include;  Firm, Name, title , phone number, address of the complaintant  Date complaint is received Date complaint is received  Complaint nature (Product & batch number of the API)  Immediate Action taken if any (dates & action taken by the person)  Investigation & CAPA  Response provided to the originator of complaint with date  Final decision / Conclusion  Follow-up action taken
ICH Q7: 15.0 COMPLAINTS AND RECALLS  Records of complaints should be retained in order to evaluate trends, product related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.  There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered.  The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.  In the event of a serious or potentially life-threatening situation, local, national, and/or international authorities should be informed and their advice sought.
PROCEDURE FOR HANDLING OF COMPLAINTS  SOP for investigation and reporting the market complaints should cover the following, but not limited to  Purpose, Scope, Responsibility & Authority  Cover all quality-related or other complaints, whether received orally or in writing, is being recorded and investigatedorally or in writing, is being recorded and investigated  Record the receipt of the complaint in complaint log book  Acknowledge the receipt of complaint (timeline eg within 24hrs)  Classify on nature of complaint. eg. Product quality , Packaging, Document, Label etc  Categorize as Critical / Major / Minor
PROCEDURE FOR HANDLING OF COMPLAINTS  Containment of complaint batch , if required  Investigation of complaint based on the complaint nature. Testing of reserve sample, review of manufacturing and test records, Equipment, calibration, facility, environment etc ..  Time period for investigation Time period for investigation  Content of Investigation report and response to customer  If complaint is not genuine or send response with justification  Remedial action and CAPA as appropriate  Closing of complaint  Review of effectiveness  Maintain the compliant records
COMPLAINT INVESTIGATION  Record the receipt of the complaint in complaint log book  Complaint number & Date of complaint received  Details of organisation/person, title, address, contact of complainant  Product name, Batch number, quantity and date of supply  Nature of Complaint: Quality , packing, document error, label etc  Category - Critical/ Major/ Minor Category - Critical/ Major/ Minor  Containment of material, if stock is available from the complaint batch at warehouse.  Time period for investigation and response to customer  If it is critical (life threaten) send response within 2-5 days to contain / action at customer end, and investigation can be continued  Other than critical 2-4 weeks  Interim report if investigation required time
INVESTIGATION STEPS 1. Define the Complaint 2. Evaluate the Magnitude and Impact 3. Make a Plan for Investigation 4. Identify RCA thorough Assessment 5. Remedial & CAPA plan with tasks 6. Implementation the action plan 7. Follow up /verify the effectiveness Use investigation tool as required ie. why-why, cause and effect (fish bone), brainstorm, FEMA etc
COMPLAINT INVESTIGATION  Investigation : Uses check list for review / verification  Test the reserve sample of the complaint batch. If required test the previous and subsequent to complaint batches.  Request sample from customer if required for investigation and test the sampleand test the sample  Form the Investigation team: QA, QC, production and if required ES, R&D and others  Review the records (details -next slide)  Identify the root cause or probable cause  If required visit the customer site for investigation
INVESTIGATION: REVIEW OF RECORDS  Review past history /similar issue & their investigation reports  Review the following records and documents, but not limited to;  BPR, cleaning record, test records, trend , change control ...  OOS, deviation if found  Review of input material, quality, quantity & vendor Review process/operations Review process/operations  Review the situation/ environment  Review of Systems / facility/ Equipment  Eg. Environment, Log book, cleaning,, PM, Calibration physical check etc  Interview people involved in the manufacturing, sampling & testing  Gemba-Inspect equipment & facilities at site  Any additional testing required based on the above
COMPLAINT INVESTIGATION  Review the storage & transportation, if special storage condition recommended  Extend the investigation to other batches , other campaign, other Product / materials, other Equipment / train etc  Evaluate Product Impact / Disposition Evaluate Product Impact / Disposition  Provide reason for accept / rejection of the batch based on the outcome of the investigation.  Justify the exclusion of other batch if required  Consider toxicological evaluation if required  Remedial Action/Correction: Action to address an immediate problem ie Reprocess/ reworking or can be taken in conjunction with CAPA
COMPLAINT INVESTIGATION REPORT  Prepare the Complaint Investigation report with the following details, but not limited to,  Complaint number & Date of complaint received  Details of organisation/person, title, address, contact of complainant  Product name, Batch number, quantity and date of supply  Nature of Complaint: Quality , packing, document error, label etc  Category - Critical/ Major/ Minor Category - Critical/ Major/ Minor  Immediate action taken (with date & name of person taking the action)  Investigation report with root cause or most probable cause  Remedial action or correction  Corrective action and preventive action if possible  Conclusion & Recommendation to customer if required  Decision on recall, if complaint is serious or potentially life-threatening situation.
RESPONSE TO CUSTOMER  Information to regulatory agencies if complaint is serious or potentially life-threatening situation.  Submit the investigation report to customer as per time line specified in the SOP and based on the nature of complaint.  In case the investigation require additional time, provide interim report and get extended time with justification.  The complaint shall be closed based on the acceptance of the response from the customer and assessment of CAPA.  In case the customer is not responding within 2-3 weeks send the reminder for feedback; if customer is not responding, inform as complaint is closed.
COMPLAINT VERIFICATION & RECORDS  Verify the implementation of correction and CAPA for its effectiveness.  Review the complaint periodically (may be monthly or quarterly) to determine if there are any unfavourable trends in the complaint data.trends in the complaint data.  Review all the complaints in the management review meeting  All complaints shall be reviewed and reported in APQR  Complaint records shall be maintained at least one year after retest date of API or expiration date of drug product
RECALL  Decision on recall, if complaint is serious or potentially life- threatening situation.  Information to local, national, and/or international authorities should be informed and their advice sought.  Initiate the recall as per procedure should designate who Initiate the recall as per procedure should designate who should be involved in evaluating the information,  Who should be informed about the recall, and  How the recalled material should be treated.
Thank YouThank You Dr. A. Amsavel

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Handling of Customer Complaint_Dr.A.Amsavel

  • 1. HANDLING OF CUSTOMERS COMPLAINT Dr. A. Amsavel
  • 2. OVERVIEW  Reference Guideline  Definitions  GMP Requirement: 21 CFR § 211.198 and ICH Q7  Procedure for Handling of Complaints  Complaint Investigation  Remedial action and CAPA  Report preparation  Response to customer  Verification of CAPA effectiveness  Review of Complaints
  • 3. GUIDELINES/ REQUIREMENTS  21 CFR § 211.198 Complaint files.  Investigation according to 21 CFR § 211.192 Production record review & Record and Reports shall be available § 211.180(c).§ 211.180(c).  Field Alert Report Submission Questions and Answers Guidance for Industry July 2018  ICHQ7 GMP for API: Section -15 Complaints and Recalls
  • 4. DEFINITION Correction: An action to eliminate a detected nonconformity. ie Remedial action, Reprocess, rework, or adjustment Corrective Action: The action taken to eliminate the causesCorrective Action: The action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence. Preventive Action: The action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence. 4
  • 5. DEFINITION  Conforming: Fulfillment of a requirement. An expected observation, event or characteristic.  Nonconforming Material or Process (Discrepancy) : Any material or process that does not meet its required specifications or documented procedure.specifications or documented procedure.  Nonconformity: Non-fulfillment of a specified requirement. (Any material or process that does not meet its required specifications or documented procedure).  Complaint : Customer / consumer reporting on the product or service, due to non-confirming of product or process or service. It may be related to quality, packing, document, service, etc. 5
  • 6. DEFINITION Field Alert Report (USFDA) Any incident that causes the drug product or its labeling to be mistaken for or applied to another article, bacterial contamination, a significant chemical, physical,bacterial contamination, a significant chemical, physical, or other change, deterioration in the distributed drug product, and failure of one or more distributed batches of the drug product to meet the specifications established in its application I
  • 7. PURPOSE OF COMPLAINT HANDLING  To ensure the patient safety.  To meet Regulatory Requirement  To maintain cGMP To maintain relationship with customers To maintain relationship with customers  It is reputation of company  It is an opportunity to improve the quality of the product or service  To improve the business growth
  • 8. 21CFR § 211.198 COMPLAINT FILES  Procedures shall be established and followed for handling of all written and oral complaints regarding a drug product  Any complaint involving the possible failure of a drug product to meet any of its specifications need for an investigation in accordance with § 211.192.investigation in accordance with § 211.192.  Review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration
  • 9. 21CFR § 211.198- COMPLAINT FILES.  A written record of each complaint shall be maintained at the site and readily available for inspection  Written records related to complaint shall be maintained until at least 1 year after the expiration date of the druguntil at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer.  For OTC drug products records shall be maintained for 3 years after distribution of the drug product.
  • 10. 21CFR § 211.198- COMPLAINT FILES  Record shall include the following information, the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant.  Record of Investigation conducted, and findings and Record of Investigation conducted, and findings and follow-up.  The record of the investigation shall be maintained  If investigation is not conducted, record the reason for an investigation was not necessary and the name of the responsible person making such a determination.
  • 11. ICH Q7: 15.0 COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated Complaint records should include;  Firm, Name, title , phone number, address of the complaintant  Date complaint is received Date complaint is received  Complaint nature (Product & batch number of the API)  Immediate Action taken if any (dates & action taken by the person)  Investigation & CAPA  Response provided to the originator of complaint with date  Final decision / Conclusion  Follow-up action taken
  • 12. ICH Q7: 15.0 COMPLAINTS AND RECALLS  Records of complaints should be retained in order to evaluate trends, product related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.  There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered.  The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.  In the event of a serious or potentially life-threatening situation, local, national, and/or international authorities should be informed and their advice sought.
  • 13. PROCEDURE FOR HANDLING OF COMPLAINTS  SOP for investigation and reporting the market complaints should cover the following, but not limited to  Purpose, Scope, Responsibility & Authority  Cover all quality-related or other complaints, whether received orally or in writing, is being recorded and investigatedorally or in writing, is being recorded and investigated  Record the receipt of the complaint in complaint log book  Acknowledge the receipt of complaint (timeline eg within 24hrs)  Classify on nature of complaint. eg. Product quality , Packaging, Document, Label etc  Categorize as Critical / Major / Minor
  • 14. PROCEDURE FOR HANDLING OF COMPLAINTS  Containment of complaint batch , if required  Investigation of complaint based on the complaint nature. Testing of reserve sample, review of manufacturing and test records, Equipment, calibration, facility, environment etc ..  Time period for investigation Time period for investigation  Content of Investigation report and response to customer  If complaint is not genuine or send response with justification  Remedial action and CAPA as appropriate  Closing of complaint  Review of effectiveness  Maintain the compliant records
  • 15. COMPLAINT INVESTIGATION  Record the receipt of the complaint in complaint log book  Complaint number & Date of complaint received  Details of organisation/person, title, address, contact of complainant  Product name, Batch number, quantity and date of supply  Nature of Complaint: Quality , packing, document error, label etc  Category - Critical/ Major/ Minor Category - Critical/ Major/ Minor  Containment of material, if stock is available from the complaint batch at warehouse.  Time period for investigation and response to customer  If it is critical (life threaten) send response within 2-5 days to contain / action at customer end, and investigation can be continued  Other than critical 2-4 weeks  Interim report if investigation required time
  • 16. INVESTIGATION STEPS 1. Define the Complaint 2. Evaluate the Magnitude and Impact 3. Make a Plan for Investigation 4. Identify RCA thorough Assessment 5. Remedial & CAPA plan with tasks 6. Implementation the action plan 7. Follow up /verify the effectiveness Use investigation tool as required ie. why-why, cause and effect (fish bone), brainstorm, FEMA etc
  • 17. COMPLAINT INVESTIGATION  Investigation : Uses check list for review / verification  Test the reserve sample of the complaint batch. If required test the previous and subsequent to complaint batches.  Request sample from customer if required for investigation and test the sampleand test the sample  Form the Investigation team: QA, QC, production and if required ES, R&D and others  Review the records (details -next slide)  Identify the root cause or probable cause  If required visit the customer site for investigation
  • 18. INVESTIGATION: REVIEW OF RECORDS  Review past history /similar issue & their investigation reports  Review the following records and documents, but not limited to;  BPR, cleaning record, test records, trend , change control ...  OOS, deviation if found  Review of input material, quality, quantity & vendor Review process/operations Review process/operations  Review the situation/ environment  Review of Systems / facility/ Equipment  Eg. Environment, Log book, cleaning,, PM, Calibration physical check etc  Interview people involved in the manufacturing, sampling & testing  Gemba-Inspect equipment & facilities at site  Any additional testing required based on the above
  • 19. COMPLAINT INVESTIGATION  Review the storage & transportation, if special storage condition recommended  Extend the investigation to other batches , other campaign, other Product / materials, other Equipment / train etc  Evaluate Product Impact / Disposition Evaluate Product Impact / Disposition  Provide reason for accept / rejection of the batch based on the outcome of the investigation.  Justify the exclusion of other batch if required  Consider toxicological evaluation if required  Remedial Action/Correction: Action to address an immediate problem ie Reprocess/ reworking or can be taken in conjunction with CAPA
  • 20. COMPLAINT INVESTIGATION REPORT  Prepare the Complaint Investigation report with the following details, but not limited to,  Complaint number & Date of complaint received  Details of organisation/person, title, address, contact of complainant  Product name, Batch number, quantity and date of supply  Nature of Complaint: Quality , packing, document error, label etc  Category - Critical/ Major/ Minor Category - Critical/ Major/ Minor  Immediate action taken (with date & name of person taking the action)  Investigation report with root cause or most probable cause  Remedial action or correction  Corrective action and preventive action if possible  Conclusion & Recommendation to customer if required  Decision on recall, if complaint is serious or potentially life-threatening situation.
  • 21. RESPONSE TO CUSTOMER  Information to regulatory agencies if complaint is serious or potentially life-threatening situation.  Submit the investigation report to customer as per time line specified in the SOP and based on the nature of complaint.  In case the investigation require additional time, provide interim report and get extended time with justification.  The complaint shall be closed based on the acceptance of the response from the customer and assessment of CAPA.  In case the customer is not responding within 2-3 weeks send the reminder for feedback; if customer is not responding, inform as complaint is closed.
  • 22. COMPLAINT VERIFICATION & RECORDS  Verify the implementation of correction and CAPA for its effectiveness.  Review the complaint periodically (may be monthly or quarterly) to determine if there are any unfavourable trends in the complaint data.trends in the complaint data.  Review all the complaints in the management review meeting  All complaints shall be reviewed and reported in APQR  Complaint records shall be maintained at least one year after retest date of API or expiration date of drug product
  • 23. RECALL  Decision on recall, if complaint is serious or potentially life- threatening situation.  Information to local, national, and/or international authorities should be informed and their advice sought.  Initiate the recall as per procedure should designate who Initiate the recall as per procedure should designate who should be involved in evaluating the information,  Who should be informed about the recall, and  How the recalled material should be treated.