1.0
|
PURPOSE
To lay down systematic procedure for line clearance before
commencing of packing of the batch.
|
2.0
|
SCOPE
This method is applicable to given line clearance
for packing of each batch of all products.
|
3.0
|
RESPONSIBILITY
Production Chemist/IPQA Chemist
|
4.0
|
ACCOUNTABILITY
Head QA/Head Production
|
5.0
|
PROCEDURE
|
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
5.12
|
The Production Supervisor should ensure that the
necessary precautions are taken for line cleaning before obtaining line
clearance. Before Taking line clearance from QA Deptt. fallowing activity
should be Insure
As soon as packing of a batch is over
remove all the cartons, labels, bottles, strips, outers, any material left
over on the line and on the lower space of the 2 belts joints.
Check that all the remaining material
like capsules, tablets, Soap, Ointment, Shampoo, etc. are removed out from
Packing operation area for reworking/rejects.
Remove the label of the hopper and
replace with a new one for the batch to be started and ensure that the hopper
is cleaned properly.
Remove any other packing material from
Packing area.
Insure that Stereo of previous product
is submitted to production officer.
Change the Batch details on status
board.
The Production Chemist should ensure
that line is cleaned as per SOP and all process documents and remaining
materials from the previous process are removed before inviting QA for line
clearance.
Insure correct stereo issued for
commencing product by taking overprinting details such as batch no.
manufacturing date, expiry date, and Mfg. Lic. No. and other details on all
overprinting material like the plain foil, carton, label, catch over shall be
checked by production chemist and filled line clearance check list as per
annexure I. QA Chemist shall verified Line clearance Checklist.
Put an authorized overprinted specimen
of strip/blister/cartons/Label/Tube in a folder for ready reference.
QA shall check all checkpoints as per checklist for
confirming any evidence of previous product.
Non compliance to the line clearance checklist is
immediately notified to QA Head & Production Head / Chemist.
|
6.0
|
REFERENCES
SOP guideline by D.H. Shah
|
7.0
|
ANNEXURES
|
Annexure No.
|
Title of Annexure
|
Format No.
|
Annexure I
|
LINE CLEARANCE
CHECKLIST
|
QA/032/F01-00
|
8.0
|
ABBREVIATIONS
|
Abbreviations
|
Full Forms
|
|||||||||
SOP
|
Standard Operating
Procedure
|
|||||||||
QA
|
Quality Assurance
|
|||||||||
9.0
|
DISTRIBUTION
|
|||||||||
Master Copy
|
Head Quality Assurance
Department
|
|||||||||
Controlled office Copy No. 1
|
Head Quality Assurance Deptt.
|
|||||||||
Controlled office Copy No. 2
|
Head Production (Tablet) Deptt.
|
|||||||||
Controlled office Copy No. 3
|
Head Production (Liquid)
Deptt
|
|||||||||
Controlled office Copy No. 4
|
Head Production (External)
Deptt
|
|||||||||
Controlled office Copy No. 5
|
Head Production (Soap)
Deptt
|
|||||||||
10.0
|
REVISION
HISTORY
|
|||||||||
S.No.
|
Revision No.
|
Effective
Date
|
Reason for
Revision
|
Details of
Change
|
Authorized
By
(sign
& Date)
|
|||||
Annexure I
LINE CLEARANCE CHECKLIST (PACKING AREA)
Date:
Product Name:
Mfg. Date:
Batch No.
:
Exp. Date:
Sr. No.
|
CHECK POINTS
|
OBSERVATIONS
( OK/NOT OK)
|
REMARKS
|
|
01.
|
Room is identified with the
current batch details.
|
|||
02.
|
Packing area is clean as per SOP.
|
|||
03.
|
Check the environmental
condition
|
|||
04.
|
Check absence of previous
product packing material
|
|||
05.
|
Check packing material as
per material requisition slip.
|
|||
06.
|
Insure Stereo of previous
product is not available on the machine and area.
|
|||
07.
|
Check availability of
documents pertaining to the current batch
|
|||
08
|
Check the details of Overprinted
packing material.
|
Checked By
Verified By
(Production Deptt.)
(QA Deptt.)
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