Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
SlideShare a Scribd company logo

Complaints and recalls

•Download as PPTX, PDF•
•
Kandarp KT
Kandarp KT

This document discusses complaints and recalls procedures for pharmaceutical products. It outlines the objectives of complaint handling, defines complaint procedures and classifications of defects. Critical defects pose life-threatening risks and require immediate action. Major defects present some risk to patients and require batch recall within days. Other defects have minimal risks. Recall procedures include designating an authorized person to manage the recall according to a standard operating procedure and maintaining distribution records to effectively recall affected products.

1 of 24
COMPLAINTS AND RECALLS Present By : Kandarp N. Trivedi M.Pharm.[PMRA]
CONTENTS :  Objectives  Complaint Handling Principle  Complaint Procedures  Classification of Defects  Critical Defects  Major Defects  Other Defects  Records of complaint Investigation  Recall definition  Recall process
OBJECTIVES :  To recognize the key issues in product complaint and recall handling  To identify with the specific requirements for organization, procedures and resources  To appreciate and develop actions to resolve current issues applicable to you
COMPLAINTS PRINCIPLE :  All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken  Principle should follow bellowing criteria  Manage optimistically and ingeniously reviewed.  Handle by expert staff member.  Methodical investigation of the cause is necessary.  A foremost resource of information and knowledge.  Compulsory actions taken if recall decision
COMPLAINTS PROCEDURE – I :  Selected in charge person should have perform following task  To handle complaint  Decide on quantify to be taken  If not authorized person must advise authorized person of results  Adequate support staff  Access to records  Written procedure (SOP):  Describes action to be taken  Includes require to consider a recall
COMPLAINTS PROCEDURE – II :  Comprehensive investigation:  With individual concentration to set up whether "counterfeiting" may have been the cause  Cary out Fully recorded investigation – be a sign of all the details  QC concerned  Caused by product defect (discovered or suspected):  Regard as inspection other batches  Batches containing reprocessed product
COMPLAINTS PROCEDURE – III :  Investigation and evaluation should outcome in proper follow-up actions  possibly will take account of a "recall"  All decisions and manner taken should be recorded  Referenced in batch records  Records reviewed - trends and frequent problems
ADDITIONAL ACTION TO BE :  Inform competent authorities in case of serious quality problems such as:  defective manufacture  Product deterioration  counterfeit
CLASSIFICATION OF DEFECTS :  One time defect has been identified or justified , company should be dealing with it in a suitable way, even recall  The following system has been established in some countries (but it is not a WHO guideline): A. Critical defects B. Major defects C. Other defects
A. CRITICAL DEFECTS :  Individuals defects which can be critical and require the company to take in need of attention action by all reasonable resources, whether in or out of company hours Examples  Product labelled with inaccurate name or incorrect strength  Imitation or deliberately tampered-with product  Microbiological contamination of a sterile product
B. MAJOR DEFECTS :  Those defects which possibly will put the patient at a little hazard but are not life-threatening and will require the batch recall or product withdrawal within a few days Examples  Any labelling/leaflet misinformation which represents a significant hazard to the patient  Microbial contamination of non-sterile products with some risk for patients  Disobedience to specifications
C. OTHER DEFECTS :  Individuals defects which present only a insignificant risk to the patient — batch recall or product withdrawal would normally be initiated within a few days. Examples  Readily visible inaccessible packaging/closure faults  Contamination which may cause spoilage or dirt and where there is least risk to the patient
REASONS FOR RECALL :  Patients complaint  Recognition of GMP failure after release  Consequence of an inspection  Result from the in progress stability testing  Identified counterfeiting or tampering  Adverse reaction reporting  Appeal by the national authorities
PRODUCT RECALLS: PRINCIPLE “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.”
DEFINITION :  Recall  Removal from the market of specified batches of a product , may refer to one batch or all batches of product
RECALL PROCEDURE - I :  Designated authorized responsible person  To accomplish and coordinate recalls  Decide on measure to be taken  Adequate support staff  To handle all aspects and necessity of recall
SOP FOR RECALL :  Established, written and authorized  Detailed actions to be taken  Regularly reviewed and updated  Capable of rapid operation to required level of distribution chain, e.g. hospital and pharmacy level  Store recalled products in a secure, segregated area
DISTRIBUTION RECORDS :  Allocation records on hand to authorized person and contain enough information on:  Regulatory permit effective recall  Including for clinical tests and medical samples  Batch numbers and quantities  Wholesalers  Direct customers  Export locations
PROGRESS OF RECALL :  Supervise and record the progress during the recall  Inform all competent authorities of all countries where the given product had been distributed  Final report should include reconciliation between delivered and recovered products  Record of the disposition of the product  Effectiveness of procedure tested and evaluated from time to time with reference past events.
DISCUSSION WITH EXPERT AND STAFF :  Collect 3 examples of complaints or recalls from your experience  Describe the actions to be taken by the company or authority and the implications for all interested parties  Suggest a classification of the complaint or recall into critical (life-threatening), major or other
POSSIBLE ISSUES WITH RECALL PROCEDURE  No response to justified complaints  Response to unjustified complaints  Collapse to recall  Failure to correct common complaints  No capital to investigate  No superior management support  Senior management interference
 No access to records likewise distribution information/batch records  Incapacity to contact government during holidays/weekends  Dissimilarity on harshness of defect
REFERENCES :  WHO Module 5, January 2006.  www.authorstream.com  www.wikipedia.com
THANKS ‘’Serve for Healthy India”

More Related Content

Complaints and recalls

  • 1. COMPLAINTS AND RECALLS Present By : Kandarp N. Trivedi M.Pharm.[PMRA]
  • 2. CONTENTS :  Objectives  Complaint Handling Principle  Complaint Procedures  Classification of Defects  Critical Defects  Major Defects  Other Defects  Records of complaint Investigation  Recall definition  Recall process
  • 3. OBJECTIVES :  To recognize the key issues in product complaint and recall handling  To identify with the specific requirements for organization, procedures and resources  To appreciate and develop actions to resolve current issues applicable to you
  • 4. COMPLAINTS PRINCIPLE :  All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken  Principle should follow bellowing criteria  Manage optimistically and ingeniously reviewed.  Handle by expert staff member.  Methodical investigation of the cause is necessary.  A foremost resource of information and knowledge.  Compulsory actions taken if recall decision
  • 5. COMPLAINTS PROCEDURE – I :  Selected in charge person should have perform following task  To handle complaint  Decide on quantify to be taken  If not authorized person must advise authorized person of results  Adequate support staff  Access to records  Written procedure (SOP):  Describes action to be taken  Includes require to consider a recall
  • 6. COMPLAINTS PROCEDURE – II :  Comprehensive investigation:  With individual concentration to set up whether "counterfeiting" may have been the cause  Cary out Fully recorded investigation – be a sign of all the details  QC concerned  Caused by product defect (discovered or suspected):  Regard as inspection other batches  Batches containing reprocessed product
  • 7. COMPLAINTS PROCEDURE – III :  Investigation and evaluation should outcome in proper follow-up actions  possibly will take account of a "recall"  All decisions and manner taken should be recorded  Referenced in batch records  Records reviewed - trends and frequent problems
  • 8. ADDITIONAL ACTION TO BE :  Inform competent authorities in case of serious quality problems such as:  defective manufacture  Product deterioration  counterfeit
  • 9. CLASSIFICATION OF DEFECTS :  One time defect has been identified or justified , company should be dealing with it in a suitable way, even recall  The following system has been established in some countries (but it is not a WHO guideline): A. Critical defects B. Major defects C. Other defects
  • 10. A. CRITICAL DEFECTS :  Individuals defects which can be critical and require the company to take in need of attention action by all reasonable resources, whether in or out of company hours Examples  Product labelled with inaccurate name or incorrect strength  Imitation or deliberately tampered-with product  Microbiological contamination of a sterile product
  • 11. B. MAJOR DEFECTS :  Those defects which possibly will put the patient at a little hazard but are not life-threatening and will require the batch recall or product withdrawal within a few days Examples  Any labelling/leaflet misinformation which represents a significant hazard to the patient  Microbial contamination of non-sterile products with some risk for patients  Disobedience to specifications
  • 12. C. OTHER DEFECTS :  Individuals defects which present only a insignificant risk to the patient — batch recall or product withdrawal would normally be initiated within a few days. Examples  Readily visible inaccessible packaging/closure faults  Contamination which may cause spoilage or dirt and where there is least risk to the patient
  • 13. REASONS FOR RECALL :  Patients complaint  Recognition of GMP failure after release  Consequence of an inspection  Result from the in progress stability testing  Identified counterfeiting or tampering  Adverse reaction reporting  Appeal by the national authorities
  • 14. PRODUCT RECALLS: PRINCIPLE “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective.”
  • 15. DEFINITION :  Recall  Removal from the market of specified batches of a product , may refer to one batch or all batches of product
  • 16. RECALL PROCEDURE - I :  Designated authorized responsible person  To accomplish and coordinate recalls  Decide on measure to be taken  Adequate support staff  To handle all aspects and necessity of recall
  • 17. SOP FOR RECALL :  Established, written and authorized  Detailed actions to be taken  Regularly reviewed and updated  Capable of rapid operation to required level of distribution chain, e.g. hospital and pharmacy level  Store recalled products in a secure, segregated area
  • 18. DISTRIBUTION RECORDS :  Allocation records on hand to authorized person and contain enough information on:  Regulatory permit effective recall  Including for clinical tests and medical samples  Batch numbers and quantities  Wholesalers  Direct customers  Export locations
  • 19. PROGRESS OF RECALL :  Supervise and record the progress during the recall  Inform all competent authorities of all countries where the given product had been distributed  Final report should include reconciliation between delivered and recovered products  Record of the disposition of the product  Effectiveness of procedure tested and evaluated from time to time with reference past events.
  • 20. DISCUSSION WITH EXPERT AND STAFF :  Collect 3 examples of complaints or recalls from your experience  Describe the actions to be taken by the company or authority and the implications for all interested parties  Suggest a classification of the complaint or recall into critical (life-threatening), major or other
  • 21. POSSIBLE ISSUES WITH RECALL PROCEDURE  No response to justified complaints  Response to unjustified complaints  Collapse to recall  Failure to correct common complaints  No capital to investigate  No superior management support  Senior management interference
  • 22.  No access to records likewise distribution information/batch records  Incapacity to contact government during holidays/weekends  Dissimilarity on harshness of defect
  • 23. REFERENCES :  WHO Module 5, January 2006.  www.authorstream.com  www.wikipedia.com
  • 24. THANKS ‘’Serve for Healthy India”