Complaints and recalls

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”

Complaints and recalls

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