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Complaints (QUALITY ASSURANCE)

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ShrutiBattinwar

COMPLAINTS TOPIC COVERED 1.Definition 2.Principle 3.Need for complaint handling system 4.Objectives 5.Responsibility 6.Type of complaints (CRITICAL,MAJOR ,MINOR) 7.Key for handling complaint 8.Content of product complaint data sheet 9.Steps involved in handling of complaint 10.Recordings of complain

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complaints BY SHRUTI.S.BATTINWAR B.PHARM VI SEMESTER QUALITY ASSURANCE
 Defination  Principle  Need for complaint handling system  Objectives  Responsibility  Type of complaints (CRITICAL,MAJOR ,MINOR)  Key for handling complaint  Content of product complaint data sheet  Steps involved in handling of complaint  Recordings of complain
COMPLAINTS SOMETHING WRONG or NOT GOOD ENOUGH IN PHARMACEUTICAL INDUSTRY, complaints are regarding quality of the drug product. A COMPLAINT SHOWS CUSTOMERS DISSATISFACTION ABOUT PRODUCT AND CONSEQUENTLY, ABOUT COMPANY.
PRINCIPLE All complaints and other information Concerning potentially defective product Should be carefully received According to written procedure And corrective action should be taken.
Need for complaint handling system It gives opportunity to improve quality of the product. It is helpful to maintain cGMP. It maintains committed relationship between customer and company. Regulatory obligation.
OBJECTIVE Immediately recall, investigate or take remedial measure against defective product. RESPONSIBILITY The quality manager along with manager of complaint related department .
Type of complaint QUALITY COMPLAINT • Originate at consumer level and concern with physical, chemical and biological property • Condition of labeling/packaging of product ADVERSE REAACTION COMPLAINT • Due to allergic reaction of any other untoward reaction or fatal or near fatal reaction OTHER MEDICALLY RELATED COMPLAINT • Includes lack of efficacy or clinical response
TIME PERIOD FOR INVESTIGATION AFTER RECEIPT OF COMPLAINT • PRODUCT QUALITY COMPLAINT 1O DAYS • ADVERSE REACTION COMPLAINTS 5 DAYS • MEDICAL COMPLAINTS 3 DAYS
Type of complaint CRITICAL • Can be life threatening and require company to take immediate action (even out of business hours • Eg microbiological contamination of sterile product ; product with incorrect name or incorrect strength MAJOR • May put the patient at some risk but are not life threatening and will require batch recall or product withdrawal within few days • Eg microbial combination of non sterile product(some risk for patient);lack of information (labeling/leaflet) MINOR • Minor risk to patient batch recall or product withdrawal would normally be initiated within a few day • Eg visible isolated packaging/closure fault ; Contamination which may cause spoilage or dirt and where there is minimal risk to the patient
Key points for handling complaints  Don’t take it personally.  Never act on a complaint without hearing two side story.  Say what you will do and do what you say; set the time . frame.  Keep notes
Content of a product complaint data sheet Serial number assigned to the complaints. Exact nature of the complaints. Name of the complaints. Address of the complaints. Date of the complaint received. Name of the product, strength and batch number of the product. Quantity involved in the complaint. Size of the sample obtained by QC department. Name and signature of the investigator and date. Action taken by the company. Copy of reply sent to complains.
STEPS INVOLVE IN HANDLING COMPLAINTS RECIVING COMPLAINTS TECHNICAL INVESTIGATION CORRESCTIVE ACTION AND PREVENTIVE ACTION FEEDBACK TO CUSTOMER MONTHLY REPORT AND TREND ANALYSIS
1.RECEIVING COMPLAINTS Its important to have a open channel with customer in order to receive their suggestions, doubts and complaints. These channel are toll free number, e-mail, chat room and P.O. boxes. Its necessary to have a person in charge of receiving the complaints and inputting them into an appropriate investigation form that shall be addressed to quality assurance unit for investigarion.
2.TECHNICAL INVESTIGATION Upon the receipt of investigation form, the QA unit is able to start investigation.(they are divided into 2 phase DOCUMENTATION BASED and LABORATOTY ANALYSIS) DOCUMENTATION BASED INVESTIGATION:- -consist of checking if this complaint occurred previously in the same lot or if any non-conformance was found in the lot during its production that could explain the complaint. -the primary documentation to be reviewed in this step consist of the complaint files and the batch record. LABORATORY BASED INVESTIGATION: consist of requesting the QC laboratory to analyze both complaint samples – reserve sample representative of lot of manufacture.
LABORATORY BASED INVESTIGATION: consist of requesting the QC laboratory to analyze both complaint samples – reserve sample representative of lot of manufactured. -if the customer did not send complaint sample for analysis, the laboratory investigation will be carried out only with retained samples. -similar to the receiving step, it is fundamental that the company elects a person in the QA unit to be in charge of technical investigation of each complaint e.g. Complaint Officer. -after receiving the analytical results, there are three possible conclusion: i. Confirmed Complaint ii. Non-Conformed Complaint iii. Counterfeit/ Tamper suspicion
3.CORRECTIVE ACTION AND PREVENTIVE ACTION CORRECTIVE ACTION (eliminate detected non-conformity) oIt aims to correct an existing non-conformity and avoid reoccurrence of same conformity. oEg: arises from manufacturing deviations, OOS investigation, complaints audit findings, recall. PREVENTIVE ACTION (prevent Non-conformity occurrence) oIt aims to avoid the initial occurrence of a non-conformity by pro-actively implementing improvement. oEg: result from trending in process data, of analytical data, of audit findings, trending of root causes for non-conformities or complaints, from product quality reviews (annual product reviews), quality risk analysis.
For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective action and Preventive active (CAPA) handling. The criteria for choosing appropriate action depends on the nature of the complaint, and the complaint incidence. If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory affairs and Production Management must be established. Concerning non-conformed complaints originating from the misuse or inadequate handling of the drug product, even if there is no need for internal corrective actions, corrective measures should be implemented to provide orientation to the customer. Regarding counterfeit or tampered suspicious complaints, a response letter should also be sent to the customer, but the legal affairs unit must be copied for further arrangements.
4.FEEDBACK TO CUSTOMERS As feedback to the customer, the company must write a response letter to the complaint to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was comfirmed. The customer should be sent a free replacement product together with the response letter, since the customer returned to the product (the complaint sample) to the company for analysis and 5.MONTHLY REPORTS AND TREND ANALYSIS Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints.
RECORDING OF COMPLAINTS Its responsibility of the in-charge, Quality control to see that each complaint is recorded, evaluated and reported to the management. Includes the following information: 1. Content Complaints- these should include: •Name, dosage form, package form, batch number •Date and the place of occurrence of complaints •Cause of complaints •Name and address of complaint in detail
2. Results of investigation : it include •Regarding market place, circulation condition and condition in which the defect was observed. •Results of investigation of analysis and testing records, production and storage records. 3. Evaluation 4. Follow up measures : it include •Reply to the complainant. •Remedial action so that complaint of this type should not reoccur.
THANKYOU HAVE A NICE DAY

More Related Content

Complaints (QUALITY ASSURANCE)

  • 1. complaints BY SHRUTI.S.BATTINWAR B.PHARM VI SEMESTER QUALITY ASSURANCE
  • 2.  Defination  Principle  Need for complaint handling system  Objectives  Responsibility  Type of complaints (CRITICAL,MAJOR ,MINOR)  Key for handling complaint  Content of product complaint data sheet  Steps involved in handling of complaint  Recordings of complain
  • 3. COMPLAINTS SOMETHING WRONG or NOT GOOD ENOUGH IN PHARMACEUTICAL INDUSTRY, complaints are regarding quality of the drug product. A COMPLAINT SHOWS CUSTOMERS DISSATISFACTION ABOUT PRODUCT AND CONSEQUENTLY, ABOUT COMPANY.
  • 4. PRINCIPLE All complaints and other information Concerning potentially defective product Should be carefully received According to written procedure And corrective action should be taken.
  • 5. Need for complaint handling system It gives opportunity to improve quality of the product. It is helpful to maintain cGMP. It maintains committed relationship between customer and company. Regulatory obligation.
  • 6. OBJECTIVE Immediately recall, investigate or take remedial measure against defective product. RESPONSIBILITY The quality manager along with manager of complaint related department .
  • 7. Type of complaint QUALITY COMPLAINT • Originate at consumer level and concern with physical, chemical and biological property • Condition of labeling/packaging of product ADVERSE REAACTION COMPLAINT • Due to allergic reaction of any other untoward reaction or fatal or near fatal reaction OTHER MEDICALLY RELATED COMPLAINT • Includes lack of efficacy or clinical response
  • 8. TIME PERIOD FOR INVESTIGATION AFTER RECEIPT OF COMPLAINT • PRODUCT QUALITY COMPLAINT 1O DAYS • ADVERSE REACTION COMPLAINTS 5 DAYS • MEDICAL COMPLAINTS 3 DAYS
  • 9. Type of complaint CRITICAL • Can be life threatening and require company to take immediate action (even out of business hours • Eg microbiological contamination of sterile product ; product with incorrect name or incorrect strength MAJOR • May put the patient at some risk but are not life threatening and will require batch recall or product withdrawal within few days • Eg microbial combination of non sterile product(some risk for patient);lack of information (labeling/leaflet) MINOR • Minor risk to patient batch recall or product withdrawal would normally be initiated within a few day • Eg visible isolated packaging/closure fault ; Contamination which may cause spoilage or dirt and where there is minimal risk to the patient
  • 10. Key points for handling complaints  Don’t take it personally.  Never act on a complaint without hearing two side story.  Say what you will do and do what you say; set the time . frame.  Keep notes
  • 11. Content of a product complaint data sheet Serial number assigned to the complaints. Exact nature of the complaints. Name of the complaints. Address of the complaints. Date of the complaint received. Name of the product, strength and batch number of the product. Quantity involved in the complaint. Size of the sample obtained by QC department. Name and signature of the investigator and date. Action taken by the company. Copy of reply sent to complains.
  • 12. STEPS INVOLVE IN HANDLING COMPLAINTS RECIVING COMPLAINTS TECHNICAL INVESTIGATION CORRESCTIVE ACTION AND PREVENTIVE ACTION FEEDBACK TO CUSTOMER MONTHLY REPORT AND TREND ANALYSIS
  • 13. 1.RECEIVING COMPLAINTS Its important to have a open channel with customer in order to receive their suggestions, doubts and complaints. These channel are toll free number, e-mail, chat room and P.O. boxes. Its necessary to have a person in charge of receiving the complaints and inputting them into an appropriate investigation form that shall be addressed to quality assurance unit for investigarion.
  • 14. 2.TECHNICAL INVESTIGATION Upon the receipt of investigation form, the QA unit is able to start investigation.(they are divided into 2 phase DOCUMENTATION BASED and LABORATOTY ANALYSIS) DOCUMENTATION BASED INVESTIGATION:- -consist of checking if this complaint occurred previously in the same lot or if any non-conformance was found in the lot during its production that could explain the complaint. -the primary documentation to be reviewed in this step consist of the complaint files and the batch record. LABORATORY BASED INVESTIGATION: consist of requesting the QC laboratory to analyze both complaint samples – reserve sample representative of lot of manufacture.
  • 15. LABORATORY BASED INVESTIGATION: consist of requesting the QC laboratory to analyze both complaint samples – reserve sample representative of lot of manufactured. -if the customer did not send complaint sample for analysis, the laboratory investigation will be carried out only with retained samples. -similar to the receiving step, it is fundamental that the company elects a person in the QA unit to be in charge of technical investigation of each complaint e.g. Complaint Officer. -after receiving the analytical results, there are three possible conclusion: i. Confirmed Complaint ii. Non-Conformed Complaint iii. Counterfeit/ Tamper suspicion
  • 16. 3.CORRECTIVE ACTION AND PREVENTIVE ACTION CORRECTIVE ACTION (eliminate detected non-conformity) oIt aims to correct an existing non-conformity and avoid reoccurrence of same conformity. oEg: arises from manufacturing deviations, OOS investigation, complaints audit findings, recall. PREVENTIVE ACTION (prevent Non-conformity occurrence) oIt aims to avoid the initial occurrence of a non-conformity by pro-actively implementing improvement. oEg: result from trending in process data, of analytical data, of audit findings, trending of root causes for non-conformities or complaints, from product quality reviews (annual product reviews), quality risk analysis.
  • 17. For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective action and Preventive active (CAPA) handling. The criteria for choosing appropriate action depends on the nature of the complaint, and the complaint incidence. If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory affairs and Production Management must be established. Concerning non-conformed complaints originating from the misuse or inadequate handling of the drug product, even if there is no need for internal corrective actions, corrective measures should be implemented to provide orientation to the customer. Regarding counterfeit or tampered suspicious complaints, a response letter should also be sent to the customer, but the legal affairs unit must be copied for further arrangements.
  • 18. 4.FEEDBACK TO CUSTOMERS As feedback to the customer, the company must write a response letter to the complaint to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was comfirmed. The customer should be sent a free replacement product together with the response letter, since the customer returned to the product (the complaint sample) to the company for analysis and 5.MONTHLY REPORTS AND TREND ANALYSIS Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints.
  • 19. RECORDING OF COMPLAINTS Its responsibility of the in-charge, Quality control to see that each complaint is recorded, evaluated and reported to the management. Includes the following information: 1. Content Complaints- these should include: •Name, dosage form, package form, batch number •Date and the place of occurrence of complaints •Cause of complaints •Name and address of complaint in detail
  • 20. 2. Results of investigation : it include •Regarding market place, circulation condition and condition in which the defect was observed. •Results of investigation of analysis and testing records, production and storage records. 3. Evaluation 4. Follow up measures : it include •Reply to the complainant. •Remedial action so that complaint of this type should not reoccur.