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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