1.0
OBJECTIVE:
To describe the procedure for reconciliation of
printed packaging materials to avoid misuse and mix ups.
2.0
SCOPE:
This SOP is applicable to printed packaging material
procured at --------------------------------
3.0
RESPONSIBILITY:
Production
Officer/designee & HOD responsibility for follow this SOP, and IPQA Officer
& Q.A. Head responsible for complies this SOP.
4.0
ACCOUNTABILITY:
The Accountability lies upon implementation &
complies production HOD & Q.A. Head.
5.0
PROCEDURE:
5.1
The printed
packaging material can be divided in 3 parts:-
5.1.1
Labels,
cartons, Shippers.
5.1.2
Aluminum
Foils.
5.1.3
Inserts or leaflet
or literature, ROPP Caps, Tubes.
5.2
Procedure for
Labels, cartons, Shippers:
5.2.1
After
completion of packing of particular batch, determine the quantity of labels,
cartons and shippers (Packing material) consumed taking into account the packed
quantity for FGTN and transfer to FG store. There after reconciliation of
rejections of packing material on the packing processing, sample drawn by QA
department for In-process testing, for control sample and stability sample and
quantity left unused in hand.
5.2.2
And Compare
the consumed quantity with the requisition quantity.
5.2.3
Determine
whether the unused quantity that is left in hand that can be returned to
Warehouse with Excess Material Requirement / Return Memo or not i.e. the
overprinted labels, cartons and shippers cannot be used for next batch and
hence are to be destroyed as per destruction SOP. The labels, cartons and
shippers that are not overprinted shall be return to Warehouse.
5.3
Procedure for
Aluminum Foil:
5.3.1
Reconcile the
foil by comparing the quantity issued and consumed in batch packing
5.3.2
If any foil
is left then overprinted part of the foil shall be removed and destroyed.
5.3.3
The remaining
foil shall be weighed and return to Warehouse with Excess Material Requirement
/ Return Memo
5.4
Procedure for
Inserts of leaflet or literature, ROPP Caps:
5.4.1
As there
shall be no overprinting on leaflet or ROPP caps, they shall be counted or an
approximation shall be made and returned to Warehouse with Excess Material
Requirement / Return Memo
5.4.2
Acceptance criteria: Reconciliation of issued quantity should be match with used, rejected,
destroyed and returned qty.
5.4.3
Frequency: After
completion of packing of every batch.
6.0
LIST OF ANNEXURE AND FORMAT:
Sr. No. |
Title of
Format |
Format No. |
01 |
NA |
NA |
7.0
REFERENCES:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-014
8.0
REVISION HISTORY:
Sr. No. |
Date |
Reason for Revision |
Revision No |
1.
|
31/10/2018 |
New SOP |
R0 |
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
Sr. No |
Abbreviations |
Details |
|
SOP |
Standard
operating procedure |
|
NA |
Not applicable |
|
QA |
Quality
assurance |
|
ROPP |
Round of
pilfer proof |
|
HOD |
Head Of
Department |
|
FGTN |
Finish Good
Transfer Notes |
|
FG Store |
Finish Good Store |
END
OF DOCUMENT
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Pharmaceutical guideline only