POST OPERATIONAL ACTIVITIES
(COMPLAINT HANDLING)
NAVIN K KHARE
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9.0. INTRODUCTION
Satisfactory feed back
Unsatisfactory feed back
9.1. DISTRIBUTION
Certificate
Release of Batch
Distribution of record
9.2. RECALLED PRODUCT
REASON
FDA instruction
Market complaint
Quality Problem
Damage
HANDLING RECALLS
SOP
Promptness
Dummy Recall
Responsible Person
Distribution Record
Inform Authority
Receiving Recall
Reconciliation
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Check List
9.3 RETURNED PRODUCT
Reason , Quality , Damage Stability
Handling
Identity/Store secure
Record
Assessment by QC
Reprocess
Precaution
Investigate
9.4 COMPLAINT AND ADVERSE EVENT
Adverse Drug Reaction/ Unexpected adverse drug reaction/ Adverse Event
Handling
Sop/ Responsible Person/ Investigation/Record of Action/ Record in factory/
Duration of record/ Content of record/ Review Record /Trend Analysis
9.5 DRUG PRODUCT SALVAGING
Applicable: Meets Quality
Not Applicable: If active content damaged Record of disposition
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INTRODUCTION
Pharmaceutical manufacturing and distribution
Distribution is a cyclic process
Develop………… Production………Distribution…..
Feedback
Satisfactory feed back from customer: if more demand &
product is there.
Unsatisfactory feedback from customer: complaint is
received. Recall the product, remove deficiency , redevelop
product i.e salvage, if defect removal not possible, reject the
product.
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Follow Regulatory guidelines on
following post operational activities
Distribution of Finished products
Recalled Products
Returned Products
Complaints and adverse reaction etc
Drug product salvaging.
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9.1 DISTRIBUTION
Product is manufactured and attributed for sales.
Maintain record of distribution upto whole sale level .
Usual market godown or c&f maintains distribution record .
It is needed for traceability , recall etc .
Regulatory guideline states.
A)Release of batch
Quarantine batch till released by QA then it is stored as
usable stock, store as per label claim
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B QC Certificate
Batch is passed by QC. QC certificate should be available with
manufacturer
C) Distribution Record
Name and strength of product
B.No
Name and address of consigner
Quantity dispatched
Documents Required
SOP on distribution of finished product or sample
Record of distribution
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9.2 RECALLED PRODUCTS
Distributed product is recalled due to following reasons
Reasons for Recall
1 .FDA instruction:
Due to quality or other reason FDA orders to recall product
2. Market complaint:
Physician/custom complains. If problem is genuine, product is
recalled.
3 .Quality Problem:
Stability problem, or other quality problem after release, it is recalled
by manufacturer.
4.Damage:
Damage may occur due to transport or other problem. Product become
un-suitable for use. It is recalled
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Handling of Recalls
SOP: The SOP is available to recall product
Promptness : Should be there to recall
Dummy Recall: Mock Trial should be taken for dummy recall,
for effectiveness
Responsible Person: Usually QA, or other person is responsible
.He co-ordinates with distribution or Marketing to recall. He is
supported by team of staff.
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Distribution Record: Distribution/marketing has distribution
record, with name, phone, fax, qty etc.
Inform Authority:
Who has stock, inform them for recall/stop sale promptly.
Receiving Recall:
Recalled stock is stored in secured place, and wait for decision
Reconciliation:
Reconcile market recall, dispatched and consumed material.
Record recall process
Check list:
Is kept ready
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Documents Required
SOP of recalling of finished product of the distribution
Record of recalled product.
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9.3 RETURNED PRODUCT
Identify or store secure Market return. Keep in secure place.
Record The detail
Name of product/strength
B.No
MFG
BXP
Quantity returned
Reason for return
Disposition of return
Date of disposition of return
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Assessment by QC
Based on time elapsed, batch history , condition,
examination
QC recommends:
Resale , Repacking, Reprocessing, destruction.
Reprocess.
If it on meets quality standard
Precaution:
In case of doubt of quality it is rejected
Investigate:
Assess returned batch and associated batches.
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Document Required
SOP on handling of returned product
Record of returned product and action taken.
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9.4 COMPLAINT AND ADVERSE EVENTS
The complaints are feed back, to improve the quality of product
It may lead to recall of product
Complaints related to drug reaction
Adverse Drug Reaction: It is mentioned on product insert.
Unexpected adverse drug reaction: This unexpected
Adverse event or experience:
Untoward medical phenomena, eg Minoxidil was given for BP,
it helped in hair grow/ baldness.
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SOP
Details SOP is available to handle complaints. Maintain record for
action taken
Responsible Person
Senior person to from quality management tackles. He is
experienced persons. He is supported by slot. Co-ordinate with
distribution for recall.
Investigation
The batch is checked. Related batches are also checked which
contain rework material of said batch.
Record of action and steps taken: maintain record
Record: is kept in factory where product was produced
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Duration of record
Maintain record 1 year after expiry
Maintain record 3 year after distribution for OTC product.
Content of record:
Name and strength of product
B.No
Name of component
Nature complaint
Detail of action, investigation
If no investigation, record reason, name who not to
investigate
Review of record:
To know it is recurring and repeated recall.
Trend Analysis: To know about repeated problem. Take corrective
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Adverse Event:
Responsible Person; From quality management support by
team of staff handles
He is experienced and knowledgeable
Investigation is done thoroughly
Record of Action and measures taken is maintained
Corrective Action if recurrence is there
Recall the batch if necessary.
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Documents Required
SOP/R on complaint handling
SOP/R on adverse event handling.
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9.5 DRUG PRODUCT SALVAGING:
APPLICABLE
Applicable: on product store in ware house of company or in market
place
Product meets quality standards: Identify , strength, purity and safety
i.e conforms to quality parameters
Product should meet quality standard and organoleptic requirement.
Record: For drug product salvaging is maintained
Name/Strength of product
B.No
Disposition of batch
SOP: detail SOP is available
Document Required
SOP and record of salvaged product
20 Not applicable: IF API/ active drug of product damage due to expiry ,
age, temp, RH, storage, radiation light etc.
THANK YOU..
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