1.0
|
PURPOSE
To Lay down systematic procedure to establish
handling of returned material/ products from market.
|
2.0
|
SCOPE
This method is applicable for the handling of
returned material/products from market.
|
3.0
|
RESPONSIBILITY
Production Head / Tech. Director/ Head
Quality Assurance
|
4.0
|
ACCOUNTABILITY
Head Quality Assurance
|
5.0
|
PROCEDURE
|
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
|
Any
material or goods (Finished products &/or intermediates) returned from
the market shall be stored in a separate area dedicated for storage of
returned goods.
Record
all the details in Returned Goods Record, as per the Annexure-II.
Inform
the Quality Assurance department for evaluation of the returned goods.
The
Quality Assurance chemist shall evaluate the returned goods for the
following:
(a) Check the COA and other documents with
the returned consignment.
(b)
Condition of the Packaging, carton and container.
(c) Labeling details.
If
the returned materials has exceeded the labeled expiry period &/or the
condition of the packaging, carton, container and storage condition of the
material before returning/ shipping are doubtful, then destroy the material
as per the XXX/SOP/QA/014 for control sample destruction.
If
none of the above condition is apparent, then sample the material as per the XXX/SOP/QA/013
for sampling of the FG.
Analyze
the sample as per the current approved product specification. If the product
meets appropriate product specification, then the returned material/ product
may be considered for reprocessing as per the SOP for reprocessing, provided
the subsequent product meets the product specification.
In
case the sample fails to meet the product specification, destroy the
material/product as per the SOP for destruction, and initiate failure investigation.
Identify
the batches manufactured during the same period &/or manufactured by
using the same RM’s. Extend the investigation to these batches also.
Refer
flow chart for handling of the returned material/ products as per Annexure I.
|
6.0
|
REFERENCES
NIL
|
7.0
|
ANNEXURES
|
Annexure No.
|
Title of Annexure
|
Format No.
|
Annexure I
|
FLOW CHART OF HANDLING OF
RETURNED MATERIAL/PRODUCT
|
QA/033/F01-00
|
Annexure
II
|
RETURNED
MATERIAL/ PRODUCT RECORD
|
QA/033/F02-02
|
8.0
|
ABBREVIATIONS
|
Abbreviations
|
Full Forms
|
|||||||||
SOP
|
Standard Operating
Procedure
|
|||||||||
QA
|
Quality Assurance
|
|||||||||
COA
|
Certificate of Analysis
|
|||||||||
FG
|
Finished good
|
|||||||||
9.0
|
DISTRIBUTION
|
|||||||||
Master Copy
|
Head Quality Assurance
Department
|
|||||||||
Controlled office Copy No. 1
|
Head Quality Assurance Deptt.
|
|||||||||
10.0
|
REVISION
HISTORY
|
|||||||||
S.No.
|
Revision No.
|
Effective
Date
|
Reason for
Revision
|
Details of
Change
|
Authorized
By
(sign
& Date)
|
|||||
Annexure I
FLOW CHART OF HANDLING OF
RETURNED MATERIAL/PRODUCT
Annexure II
RETURNED MATERIAL/ PRODUCT RECORD
Returned
Product details
|
Reason for Return
|
Condition
|
Disposition Details
|
Checked By
|
||||||
Name
|
Batch No.
|
A. R. No.
|
Mfg. Date
|
Exp. Date
|
Quantity
|
Decision
|
Date
|
|||
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