I.
PURPOSE
To describe
the procedure for the recall of the marketed products, which are found or
suspected of not meeting the quality parameters.
II.
SCOPE
This SOP is
applicable to recall the finished product from the market at Unit-V.
III.
RESPONSIBILITY
Head QA
Head
Marketing
IV.
ACCOUNTABILITY
Managing
Director
V.
PROCEDURE
1.0
Reasons for recall
1.1 If any degradation,
detoriation is observed during the stability study.
1.2 If instructions are
given by FDA or Drug Control Authority of India.
1.3 A customer complaint, which has been
established after investigation.
1.4 If any major variation in quality is
observed.
1.5 Change in physical parameters like odour
,colour, taste.
1.6 If any discrepancy is found in the
label over coding.
1.7 Package is damaged during the transit.
2.0
In any of the
above cases trace the location of the batch through the distribution record
of
the product and recall the marketed
batch.
3.0
If any
complaint is received from the market, then the Head QA decides the recall after consulting the Head-Production,
Plant-Head, Corporate QA-Head and getting approval
from the Director as per the Format No.: F01/SOPQA015-00.
4.0 The Head QA
immediately informs the Head - Marketing through telephone, telex,
fax, E-mail and asks him to stop the further
sales of the batch. The Head Marketing must give the follow up in a written form.
5.0 If the recall
is confined within India, then intimate the drug control authority of India
& local FDA and send the recall request to all the depot
locations through fax / register letter/courier
service /E-mail.
6.0 If the batch
to be recalled has been exported, then inform the respective regional director /country manager through fax/courier/ E-mail
and ask him to recall the batch. The
director/country manager should inform the regulatory agency of the
importing country.
7.0
After receiving the recalled product, Warehouse Head
informs the QA.
8.0 QA Head
compares the stocks returned from the market with the despatch record and
fills the
‘Recalled Product checklist’ as per the Format No.:F02/SOPQA015-00.
9.0 Update the recalled stock record.
10.0 Store the recalled product separately
11.0
Head QA investigates the cause of failure leading to the product recall
and recommends the corrective action.
12.0 After the date of destruction is confirmed
from the legal authorities, QA Head fills
the ‘Destruction approval form’ as per the Format No.: F03/SOPQA015-00 ,duly signed
by Head QA, and the destruction must be done in the presence of Head QA, Head Warehouse, and Head Production.
13.0
The records of product recall should be filed in QA.
14.0 List of formats
Format No.
|
Title |
F01/SOPQA015-00
|
Authorization
for product recall
|
F02/SOPQA015-00
|
Recalled
Product Checklist
|
F03/SOPQA015-00
|
Destruction
approval form
|
VI. REVISION SUMMARY
Version No.
|
Revised on
|
Reason for Revision |
00
|
NA
|
NA |
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