1. Module 5Slide 1 of 24 WHO - EDM Part One, Sections 6 and 7 Basic Principles of GMP Complaints and Recalls

2. Module 5Slide 2 of 24 WHO - EDM Part One, 7.1 Complaints and Recalls Product Complaint Principle “All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures.” (WHO GMP)

3. Module 5Slide 3 of 24 WHO - EDM Complaints and Recalls Objectives l To identify the key issues in product complaint and recall handling l To understand the specific requirements for organization, procedures and resources l To understand and develop actions to resolve current issues applicable to you

4. Module 5Slide 4 of 24 WHO - EDM Part One, 6.1 Complaints and Recalls Complaints Handling Principle l All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures ä Handled positively and carefully reviewed ä Must be seen as important work ä Managed by a senior staff member ä Thorough investigation of the cause is essential ä A major source of information and learning ä Enable possible production defects to be remedied before they lead to a recall. ä Necessary actions taken -- even a recall decision

5. Module 5Slide 5 of 24 WHO - EDM Part One, 6.2 – 6.9 Complaints and Recalls Complaints Procedure - I l Designated responsible person ä May be authorized person ä If not, must advise authorized person of results ä Sufficient support staff ä Access to records l Written procedure describing action to be taken l Acknowledge and respond to complainant within a reasonable period l Record written and verbal comments

6. Module 5Slide 6 of 24 WHO - EDM Part One, 6.2 – 6.9 Complaints and Recalls Complaints Procedure - II l Investigate and review l QA review complaint l Appropriate follow up actions l Review of trends

7. Module 5Slide 7 of 24 WHO - EDM Part One, 6.4 Complaints and Recalls Records of Complaint Investigation l Name of product l Name of active substance (INN) if necessary l Strength, dosage form l Batch number l Name of complainant and nature of complaint l Records, retention sample investigated, other batches reviewed and staff interviewed l Result of investigation: “Justified” or “Not justified” l If “justified”, actions taken to prevent reoccurrence l Sign-off upon completion

8. Module 5Slide 8 of 24 WHO - EDM Complaints and Recalls Decision from a Complaint Investigation l Complaint justified ä Actions to prevent reoccurrence ä Ongoing observation of process ä Recall product may be required l Complaint not justified ä Advise customer of findings ä Appropriate marketing response

9. Module 5Slide 9 of 24 WHO - EDM Part One, 6.8 Complaints and Recalls Other issues l Regular review of trends required ä Reoccurring problems ä Potential recall or withdrawal l Inform competent authority of serious quality problems

10. Module 5Slide 10 of 24 WHO - EDM Complaints and Recalls Classification of Defects l If complaint is justified, then there has been a failure of the quality system l Once defect has been identified, company should be dealing with it in an appropriate way, even recall. l The definition of defects is useful. l The following system has been found in some countries (but it is not a WHO guideline): ä Critical defects ä Major defects ä Other defects

11. Module 5Slide 11 of 24 WHO - EDM Complaints and Recalls Critical Defects l Those defects which can be life threatening and require the company to take immediate action by all reasonable means, whether in or out of business hours Examples ä Product labelled with incorrect name or incorrect strength ä Counterfeit or deliberately tampered-with product ä Microbiological contamination of a sterile product

12. Module 5Slide 12 of 24 WHO - EDM Complaints and Recalls Major Defects l Those defects which may put the patient at some risk but are not life threatening and will require the batch recall or product withdrawal within a few days Examples ä Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient ä Microbial contamination of non-sterile products with some risk for patients ä Non-compliance to specifications (e.g. active ingredient assay)

13. Module 5Slide 13 of 24 WHO - EDM Complaints and Recalls Other Defects l Those defects which present only a minor risk to the patient — batch recall or product withdrawal would normally be initiated within a few days Examples ä Readily visible isolated packaging/closure faults ä Contamination which may cause spoilage or dirt and where there is minimal risk to the patient

14. Module 5Slide 14 of 24 WHO - EDM Complaints and Recalls Reasons for Recall l Customer complaint l Detection of GMP failure after release l Result from the ongoing stability testing l Request by the national authorities l Result of an inspection l Known counterfeiting or tampering l Adverse reaction reporting

15. Module 5Slide 15 of 24 WHO - EDM Complaints and Recalls Detection of GMP failure l The photo shows an active tablet in the row of placebos in a bi-phasic oral contraceptive blister pack.

16. Module 5Slide 16 of 24 WHO - EDM Part One, 7.1 Complaints and Recalls Product Recall Principle “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.” (WHO GMP)

17. Module 5Slide 17 of 24 WHO - EDM Complaints and Recalls Definition l Recall ä Removal from the market of specified batches of a product ä May refer to one batch or all batches of product

18. Module 5Slide 18 of 24 WHO - EDM Part One, 7.2, 7.3 Complaints and Recalls Designated Responsible Recall Person l May be authorized person l If not, must advise authorized person of results l Sufficient support staff for urgency of recall l Independent of sales and marketing l Access to records

19. Module 5Slide 19 of 24 WHO - EDM Part One, 7.2, 7.3 Complaints and Recalls SOP for Recall l Established, authorized l Actions to be taken l Regularly checked and updated l Capable of rapid operation to hospital and pharmacy level l Communication concept to national authorities and internationally

20. Module 5Slide 20 of 24 WHO - EDM Part One, 7.4, 7.5 Complaints and Recalls Distribution Records l Available to designated person for recall purposes l Accurate l Include information on: ä Wholesalers ä Direct customers ä Batch numbers ä Quantities

21. Module 5Slide 21 of 24 WHO - EDM Part One 7.6 - 7.8 Complaints and Recalls l Written progress report and reconciliation ä Record progress as procedure followed ä Reconcile delivered with recovered products ä Issue final report l Effectivemess of procedures checked ä Test effectiveness from time to time l Secure segregated storage of returned goods ä Essential to keep returned goods away from other goods

22. Module 5Slide 22 of 24 WHO - EDM Complaints and Recalls Group Session l Collect 3 examples of complaints or recalls from your experience l Describe the actions to be taken by the company or authority and the implications for all interested parties l Suggest a classification of the complaint or recall into critical (life threatening), major or other

23. Module 5Slide 23 of 24 WHO - EDM Complaints and Recalls Possible Issues – I l No response to justified complaints l Response to unjustified complaints l Failure to recall l Failure to correct frequent complaints l No resources to investigate l No senior management support l Senior management interference

24. Module 5Slide 24 of 24 WHO - EDM Complaints and Recalls Possible Issues – II l No distribution information/batch records l No access to records l Inability to contact government during holidays/weekends l Disagreement on severity of defect