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. 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”