1. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency 1 Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 Prepared by Heng Huot - Cambodia Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Committee ASEAN GMP TRAINING MODULE PRODUCT COMPLAINT

2. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 2  Introduction  Objective  Scope  Definition of product complaint  Basic Principle of Product Complaints  Complaint Handling Principles  References CONTENT OF PRESENTATION

3. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 3 INTRODUCTION

4. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 4 This module is to assist the cosmetic manufacturer and distributor to establish a system to handle product complaints based on its quality, safety and efficacy; Any activity related to complaint handling must be aligned to the adopted Post Marketing Surveillance guideline. INTRODUCTION

5. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 5  To identify the key issues in product complaint.  To put in place a system, procedures and resources to resolve product complaint. OBJECTIVES

6. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 6 All complaints and other information concerning potentially defective products. SCOPE

7. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 7 A complaint is when a customer or any other (internal or external party) has reported a product defects, adverse events, or serious adverse events with any of the company's marketed products. This is valid regardless of whether:  the report is written or verbal  there is a returned product attached to the report or not The defective product :  proved to be harmful under condition of use.  lacking in quality, safety, and efficacy.  the qualitative and quantitative composition of the product is not as declared.  the manufacturing process has not been fulfilled. DEFINITION

8. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 8 BASIC PRINCIPLE OF PRODUCT COMPLAINTS

9. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 9 “All complaints and other information concerning potentially defective products must be carefully investigated according to written procedures.” PRODUCT COMPLAINT PRINCIPLE

10. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 10 The manufacturer should be responsible to impose self-regulation upon itself and to remove sub- standard or defective products as fast as possible from the market. It would be in the interest of the company to assign responsible person to:  investigate product complaints  identify & rectify product shortcomings  manage product recalls  monitor adverse events ROLES OF MANUFACTURER

11. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 11 1.Complaints should be handled in accordance with a written procedure 2.Carefully reviewed and handled positively 3.Managed by an appointed responsible person 4.Must be given importance 5.Thorough investigation of the cause is essential 6.A major source of information and learning 7.Enable possible production defects to be remedied before they lead to a recall. 8.Necessary actions taken - even a recall decision 9.All complaints should be well documented COMPLAINT HANDLING PRINCIPLES

12. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 12 COMPLAINT HANDLING PRINCIPLES

13. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 13 Within each company a person with adequate knowledge shall be assigned the task of dealing with complaints. This person must also have the authority to decide the measures to be taken. RESPONSIBLE PERSON

14. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14 Assigned responsible person May be authorized person If not, must advise authorized person of results Sufficient support staff Access to records Written procedure describing action to be taken Acknowledge and respond to complainant within a reasonable period Record written and verbal comments Investigate and review to identify the complaint trend Appropriate follow up actions COMPLAINT HANDLING PROCEDURE

15. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 15  The person in charge of complaints is responsible for initiating the investigation immediately. The person responsible for Quality Control should normally be involved in the investigation.  The investigator is responsible for the investigation which has to be carried out immediately. The investigation shall be documented in writing.  If a product defect is discovered or suspected in a batch, consideration should be given to determine whether other batches are also affected.  The investigation should also cover:  distribution condition  condition under which the product is used INVESTIGATION

16. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 16 Records of Complaint Investigation describe : Name of product Name of active substance, if any Product type Batch number Name of complainant and nature of complaint Records, retention sample investigated, other batches reviewed and staff interviewed Result of investigation: “Justified” or “Not justified” If “justified”, actions taken to prevent reoccurrence Sign-off upon completion INVESTIGATION RECORDS

17. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 17  The person in charge of complaints is responsible for the remedial action decided upon following the outcome of investigation.  If it has been decided to make a recall some of the procedures stated in Product Recall Procedure shall be applied. The company management shall discuss possible steps to prevent defects, and take over responsibility for further handling of the cause of the complaint from the person in charge of complaints. REMEDIAL ACTIONS

18. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 18  Complaints shall always be answered by person(s) assigned by the company.  Immediate response should be given to the complainant and the manufacturer must be notified of the complaint.  If the person who complains is informed of the outcome of the investigation over the telephone, the date and information provided shall be noted. RESPONSES

19. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 19 Complaint justified  Actions to prevent reoccurrence  Ongoing observation of process  Recall product may be required Complaint not justified  Advise customer of findings  Appropriate marketing response COMPLAINT DECISION

20. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 20 If complaint is justified, then there has been a failure of the quality system Once defect has been identified, company should be dealing with it in an appropriate way, even recall. The definition of defects is useful. The following system has been found in some countries:  Critical defects  Major defects  minor defects While complaints can be classified as:  Medical (e.g unexpected adverse reactions)  Technical (e.g quality,packaging or labeling defects) COMPLAINT & DEFECTS CLASSIFICATION

21. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 21 Those defects which can be life threatening and require company to take immediate action by all reasonable means, whether in or out of business hours Examples :  Product labeled with incorrect name or incorrect formula  Counterfeit or deliberately tampered-with product CRITICAL DEFECTS

22. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 22 A defect, which is a non conforming product, obvious to the consumer, it may not be hazardous. Example:  Microbiological contamination of products with some risk for users  sub standard cosmetic products  lack of information in use or warning which represents a significant hazard to the users. MAJOR DEFECT

23. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 23 A defect,which has no important effect upon the use of the cosmetic product and does not otherwise produce a hazard. Example : Lacking in labeling, packaging. MINOR DEFECT

24. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 24 As complaints are investigated and records are built up, then trends may start to become clear. Regular review of trends required to establish :  Reoccurring problems  Potential recall or withdrawal Inform competent authority of serious quality problems TRENDS REVIEW

25. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 25 Documentation of complaint investigation : Each individual complaint and attached documents shall be filed. A final report shall be prepared and documented. In the event of product recall (product safety) the authority should be notified DOCUMENTATION

26. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 26 Procedures shall be developed within the company for the receipt of reports on complaints both inside and outside working hours. It is important that complaints reach the person in charge. All complaints are reported in the complaint form. In case of urgency can be made over the telephone and confirmed in writing. REPORTING

27. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 27 RELATED HYPERLINK DOCUMENTS  Trainer Manual of Product Complaints  SOP of Product Complaint Handling SOP of Product Complaint Handling

28. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 28 REFERENCES 1.ASEAN Guidelines for Cosmetic GMP (2003) 2.WHO EDM, Basic Principle of GMP: Complaints and Recalls part 1

29. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 13 GMP Workshop Kuala Lumpur 14-16 Nov 2005 29