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Complaints.pptx

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1. The document outlines the standard operating procedure (SOP) for handling product complaints at a pharmaceutical company. It describes the process for receiving, investigating, taking corrective actions for complaints, and generating monthly reports. 2. Key aspects of the SOP include categorizing complaints, timelines for investigation, using a product complaint data sheet to document details, conducting documentation-based and laboratory investigations, and providing feedback and corrective actions to customers. 3. Monthly reports analyze complaint trends to assess quantities and types of complaints received. This allows the company to improve product quality and maintain good customer relationships.

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COMPLAINTS BY- KASHISH WILSON ASSISTANT PROFESSOR M.M.COLLEGE OF PHARMACY, MM(DU)
CONTENTS • Introduction • SOP for complaint handling • Product Complaint Data Sheet • Steps in handling complaints • corrective actions and feedbacks to customers • Monthly report and trend analysis
INTRODUCTION In Pharmaceutical Industry Complaint is defined as a statement that is something wrong or not good enough which shows the dissatisfaction of customers about products and the company. Examples Complaint about product quality. Complaints about packaging materials.
PRINCIPLES All complaints and other information received Concerning possibly faulty items Should be carefully received According to the written procedure, corrective action should be taken
NEED FOR COMPLAINT HANDLING SYSTEM There are the following needs for a complaint handling system: • It presents a chance for the business to raise the caliber of the product. • It is beneficial to keep cGMP. • It sustains a loyal relationship between the client and the business. • It is a requirement of the law.
SOP ON COMPLAINT HANDLING OBJECTIVE: To outline the process for looking into and disclosing market concerns. RESPONSIBILITY: The quality assurance manager and the manager of the complaint-related department are both responsible. PROCEDURE: To make an enquiry easier, complaints must be divided into the following categories: • Product quality complaints (non-therapeutic). • Packaging complaints (shortages and packaging errors). • Medical complaints (therapeutic problems).
RECEIVING THE COMPLAINTS/VERBAL REPORT ( Details of the product, complainant, etc. will be taken). SPECIFIC PCR(Private Complaint Record) will be assigned. Example- PCR/001/11 RECALLS IF ANY FORWARDING TO THE HEAD OF QA, QC DEPT INVESTIGATION OF THE COMPLAINTS MAINTAIN THE COMPLAINT REGISTER
TIME PERIOD FOR INVESTIGATION After receiving of complaints there are following time periods for investigation will be taken for the following complaints: • Product quality complaints – within 5 days. • Packaging and quality complaints – within 10 days. • Medical complaint – within 3 days. Records of complaints must be kept for at least a year following drug expiry. A monthly summary for the management must be created after reviewing complaint records.
PRODUCT NAME 1. Batch no., MFG date, Expiry date. 2. Name/ address of the complainant. 3. The complainant reported through. 4. The complainant sample enclosed is yes/no. 5. The quality of the sample is enclosed. 6. Investigation report 7. Recommended corrective actions. COMPLAINT CATEGORY 1. Packaging/product quality 2. Total quantity involved. PCR received by 3. Investigation was done by Conclusion confirmed/not confirmed PCR no: PCR approved by
PRODUCT COMPLAINT DATA SHEET There are the following details complaint datasheet have: 1. Serial number of complaints 2. Exact nature of the complaints. 3. Name of the complainants. 4. Address of the complainants. 5. Date of complaint received. 6. If the verbal, name of the person who received the complaint. 7. Name of the product, strength and batch number of the product.
• The quantity involved in the complaint. • Size of the sample obtained from the complainant. • Evaluation of complaint by QC department. • Materials and records were used to perform the evaluation. • Other possible affected materials, products and results of their investigation. • Name and signature of the investigator(s) and date. • Action was taken by the company. • Copy of reply sent to the complainant.
STEPS IN HANDLING COMPLAINTS The suggested handling method is given in four parts and complies with the GMP Guidelines of the EU, USA, and Brazil. 1. Receiving complaint 2. Technical investigation 3. Corrective actions/feedback to customers. 4. Monthly reports/trend analysis
RECEIVING COMPLAINTS To accept recommendations, questions, and complaints from clients, it is important to have open lines of communication. There are the following channels for receiving complaints from the customer: a. Toll-free numbers (more flexible). b. E-mails c. Chat rooms d. P.O. Boxes The task of receiving complaints and entering them into the proper investigative forms that will be addressed must be assigned to someone.
CUSTOMER Company’s Contact person QA complaint officer The investigation will be open. The following information should be taken like customer details(Name, address, contact details) and product details(product name, Lot no, MFG and Exp date, Amount of the product with the problem, Detailed description of the complaint A toll-free number, E-mails, P.O boxes, chat rooms
TECHNICAL INVESTIGATION After receiving a complaint and investigation form QA department starts an investigation. There are two phases of technical investigation:- 1. Documentation-based investigation. 2. Laboratory analysis.
QA OFFICER LABORATORY ANALYSIS • Analyze complained sample and retained sample. • The result will be sent to the QA complaint officer. DOCUMENTATION BASED • Check previous files for complaints of the same nature. • Check batch record CONFIRMED COMPLAINTS NON - CONFIRMED COMPLAINTS The conclusion will be provided after the investigation. COUNTERFIT/TAMPER SUSPICION
CONFIRMED COMPLAINTS When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results. EXAMPLE When one tablet is missing from an intact blister in the complaint sample but there is no deviation/change in the retained sample. NON-CONFIRMED COMPLAINTS When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results. EXAMPLE Change in appearance of tablets due to light, humidity, or high- temperature exposure. COUNTERFIT/TAMPER SUSPICION When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product. EXAMPLE The colour of the product is completely different from the original product or any type of mixing takes place.
Following Points Must Be Taken Care of At The Time of Complaint Handling:-  The complaint Officer must check whether the complaint represents any serious and unexpected adverse drug reactions or not.  After the completion of the investigation, the investigation form must be signed off by the complaint officer and the QA manager.  A suitable period of time for an investigation's conclusion is 30 days.
CORRECTIVE ACTIONS AND FEEDBACKS TO CUSTOMERS Corrective measures(ranging from simple and quick training to selected employees to formal Corrective And Preventive Actions, CAPA Handling) must be carried out for all complaints that have been verified. Representatives of QA, QC, Regulatory Affairs and Product Management established the multidisciplinary team.
For non-confirmed complaints originating from misuse and improper handling of products written response together with scientific information on correct use and handling of product is provided to the customer. In order to provide feedback to the customer, the company sent a written letter to the complainant in which the company explain all the measures taken by them including the investigation approach, and the results obtained. Since the customer returned the goods (the "complaint sample") to the business for investigation and a quality issue was discovered, the consumer should also get a free replacement product along with the response letter.
4) MONTHLY REPORTS AND TREND ANALYSIS Monthly reports should be prepared in order to assess the quantity and kind of complaints received, as well as to do a trend analysis of these complaints. The following questions must be answered in the monthly reports: 1. How many complaints did the firm get within that time frame? 2. How many have been confirmed? 3. How many were unconfirmed or suspected of being counterfeit or tampered with?  Graphic data display technologies are useful tools for data analysis and presentation.  The report must be easily accessible, particularly during GMP inspections.
DOCUMENTATION OF FINAL PRODUCT COMPLAINT REPORT

More Related Content

Complaints.pptx

  • 1. COMPLAINTS BY- KASHISH WILSON ASSISTANT PROFESSOR M.M.COLLEGE OF PHARMACY, MM(DU)
  • 2. CONTENTS • Introduction • SOP for complaint handling • Product Complaint Data Sheet • Steps in handling complaints • corrective actions and feedbacks to customers • Monthly report and trend analysis
  • 3. INTRODUCTION In Pharmaceutical Industry Complaint is defined as a statement that is something wrong or not good enough which shows the dissatisfaction of customers about products and the company. Examples Complaint about product quality. Complaints about packaging materials.
  • 4. PRINCIPLES All complaints and other information received Concerning possibly faulty items Should be carefully received According to the written procedure, corrective action should be taken
  • 5. NEED FOR COMPLAINT HANDLING SYSTEM There are the following needs for a complaint handling system: • It presents a chance for the business to raise the caliber of the product. • It is beneficial to keep cGMP. • It sustains a loyal relationship between the client and the business. • It is a requirement of the law.
  • 6. SOP ON COMPLAINT HANDLING OBJECTIVE: To outline the process for looking into and disclosing market concerns. RESPONSIBILITY: The quality assurance manager and the manager of the complaint-related department are both responsible. PROCEDURE: To make an enquiry easier, complaints must be divided into the following categories: • Product quality complaints (non-therapeutic). • Packaging complaints (shortages and packaging errors). • Medical complaints (therapeutic problems).
  • 7. RECEIVING THE COMPLAINTS/VERBAL REPORT ( Details of the product, complainant, etc. will be taken). SPECIFIC PCR(Private Complaint Record) will be assigned. Example- PCR/001/11 RECALLS IF ANY FORWARDING TO THE HEAD OF QA, QC DEPT INVESTIGATION OF THE COMPLAINTS MAINTAIN THE COMPLAINT REGISTER
  • 8. TIME PERIOD FOR INVESTIGATION After receiving of complaints there are following time periods for investigation will be taken for the following complaints: • Product quality complaints – within 5 days. • Packaging and quality complaints – within 10 days. • Medical complaint – within 3 days. Records of complaints must be kept for at least a year following drug expiry. A monthly summary for the management must be created after reviewing complaint records.
  • 9. PRODUCT NAME 1. Batch no., MFG date, Expiry date. 2. Name/ address of the complainant. 3. The complainant reported through. 4. The complainant sample enclosed is yes/no. 5. The quality of the sample is enclosed. 6. Investigation report 7. Recommended corrective actions. COMPLAINT CATEGORY 1. Packaging/product quality 2. Total quantity involved. PCR received by 3. Investigation was done by Conclusion confirmed/not confirmed PCR no: PCR approved by
  • 10. PRODUCT COMPLAINT DATA SHEET There are the following details complaint datasheet have: 1. Serial number of complaints 2. Exact nature of the complaints. 3. Name of the complainants. 4. Address of the complainants. 5. Date of complaint received. 6. If the verbal, name of the person who received the complaint. 7. Name of the product, strength and batch number of the product.
  • 11. • The quantity involved in the complaint. • Size of the sample obtained from the complainant. • Evaluation of complaint by QC department. • Materials and records were used to perform the evaluation. • Other possible affected materials, products and results of their investigation. • Name and signature of the investigator(s) and date. • Action was taken by the company. • Copy of reply sent to the complainant.
  • 12. STEPS IN HANDLING COMPLAINTS The suggested handling method is given in four parts and complies with the GMP Guidelines of the EU, USA, and Brazil. 1. Receiving complaint 2. Technical investigation 3. Corrective actions/feedback to customers. 4. Monthly reports/trend analysis
  • 13. RECEIVING COMPLAINTS To accept recommendations, questions, and complaints from clients, it is important to have open lines of communication. There are the following channels for receiving complaints from the customer: a. Toll-free numbers (more flexible). b. E-mails c. Chat rooms d. P.O. Boxes The task of receiving complaints and entering them into the proper investigative forms that will be addressed must be assigned to someone.
  • 14. CUSTOMER Company’s Contact person QA complaint officer The investigation will be open. The following information should be taken like customer details(Name, address, contact details) and product details(product name, Lot no, MFG and Exp date, Amount of the product with the problem, Detailed description of the complaint A toll-free number, E-mails, P.O boxes, chat rooms
  • 15. TECHNICAL INVESTIGATION After receiving a complaint and investigation form QA department starts an investigation. There are two phases of technical investigation:- 1. Documentation-based investigation. 2. Laboratory analysis.
  • 16. QA OFFICER LABORATORY ANALYSIS • Analyze complained sample and retained sample. • The result will be sent to the QA complaint officer. DOCUMENTATION BASED • Check previous files for complaints of the same nature. • Check batch record CONFIRMED COMPLAINTS NON - CONFIRMED COMPLAINTS The conclusion will be provided after the investigation. COUNTERFIT/TAMPER SUSPICION
  • 17. CONFIRMED COMPLAINTS When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results. EXAMPLE When one tablet is missing from an intact blister in the complaint sample but there is no deviation/change in the retained sample. NON-CONFIRMED COMPLAINTS When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results. EXAMPLE Change in appearance of tablets due to light, humidity, or high- temperature exposure. COUNTERFIT/TAMPER SUSPICION When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product. EXAMPLE The colour of the product is completely different from the original product or any type of mixing takes place.
  • 18. Following Points Must Be Taken Care of At The Time of Complaint Handling:-  The complaint Officer must check whether the complaint represents any serious and unexpected adverse drug reactions or not.  After the completion of the investigation, the investigation form must be signed off by the complaint officer and the QA manager.  A suitable period of time for an investigation's conclusion is 30 days.
  • 19. CORRECTIVE ACTIONS AND FEEDBACKS TO CUSTOMERS Corrective measures(ranging from simple and quick training to selected employees to formal Corrective And Preventive Actions, CAPA Handling) must be carried out for all complaints that have been verified. Representatives of QA, QC, Regulatory Affairs and Product Management established the multidisciplinary team.
  • 20. For non-confirmed complaints originating from misuse and improper handling of products written response together with scientific information on correct use and handling of product is provided to the customer. In order to provide feedback to the customer, the company sent a written letter to the complainant in which the company explain all the measures taken by them including the investigation approach, and the results obtained. Since the customer returned the goods (the "complaint sample") to the business for investigation and a quality issue was discovered, the consumer should also get a free replacement product along with the response letter.
  • 21. 4) MONTHLY REPORTS AND TREND ANALYSIS Monthly reports should be prepared in order to assess the quantity and kind of complaints received, as well as to do a trend analysis of these complaints. The following questions must be answered in the monthly reports: 1. How many complaints did the firm get within that time frame? 2. How many have been confirmed? 3. How many were unconfirmed or suspected of being counterfeit or tampered with?  Graphic data display technologies are useful tools for data analysis and presentation.  The report must be easily accessible, particularly during GMP inspections.
  • 22. DOCUMENTATION OF FINAL PRODUCT COMPLAINT REPORT