ISSUANCE
AND CODING OF PACKAGING COMPONENTS SOPS
1.0 PURPOSE
|
To ensure proper
issuance & coding of packaging components.
2.0 SCOPE
|
Ø This
Procedure is applied for issuance & coding of packaging components to
achieve the following objectives:-
Ø To
fulfill cGMP requirements
Ø For
efficient and smooth operation
Ø To
operate the system for its accountability
Ø
To minimize the
wastage of packaging components.
3.0 RESPONSIBILITY
|
Ø Production
Pharmacist
Ø Section
Supervisor
Ø Q.A
Officer
4.0 PROCEDURE
|
4.1). Issuance of Packing Components
Ø Batch
Packing Order for packing components is issued by material control department.
Ø Issuance
of packing components is done against assigned quantities of B.P.O. one day in
advance.
Ø GRN
number and quantities are entered in B.P.O. by Raw Material & Packaging
Material Store Incharge and counter checked by Production Supervisor.
Ø Packaging
components are checked for description. GRN number and issued quantities.
Ø Issuance
is done under the supervision of Production and Packaging Store Supervisors.
Ø Production
and Packaging Store Supervisors will put date & signature on B.P.O. in
respective columns.
Ø Issued
quantities are checked by Packing Supervisor for accountability & defects.
Ø Packing
Supervisor will check randomly the bundles of packing components against
claimed quantities.
Ø The
whole lots are then stacked as uncoded materials in packaging store against its
specific place.
Ø Transaction
of uncoded components for its coding is done under the supervision of
production supervisors.
Ø The
transaction is duly signed and logged in the book for its accountability.
4.2). Coding of Packaging Components
Ø Arrange
the nylon stamps in advance as per packing schedule provided which had
information about B.No. Mfg / EXP Dates and retail price.
Ø All
stamps for the month are over-printed on a separate sheet and this sheet is
kept by production supervisor.
Ø Prior
to start the coding for any particular batch, make sure that all stamps are
over-printed on the Batch Packaging Order specified for that product.
Ø Production
supervisor will check and sign each stamp being over-printed on the Batch
Packaging Order.
Ø Quality
Control Inprocess Supervisor will check and counter sign each stamp
over-printed on Batch Packing Order.
Ø Approved
Carton, Label, Inner Pack and Leaflet are attached with Batch Packaging Order
as a part of Batch History Record.
Ø After
approval by QC start the regular coding.
Ø Only
one required stamp is kept, while coding the cartons & labels.
Ø One
product is kept & coded in one coding desk.
Ø Prior
to coding each operator is instructed to check each bundle of cartons and
labels for its “CODE BAR SYSTEM” Potency and any defect.
Ø Coded
materials are given on lines under the supervision of production supervisor.
Ø Coded
packaging components are stacked in labeled empty shippers / boxes.
Ø At
the end of batch written request will be made to coding section for extra
labels or cartons.
Ø At
the completion of batch all stamps which are used for that particular batch
either on packing line or in coding section will be submitted to the production
incharge, which after its checking will finally be attached with the B.P.O. as
a part of Batch History Record.
Ø This
transaction of coded materials is rerecorded and documented in register for its
accountability and traceability.
4.3). Reconciliation:-
Ø Reconciliation
of packaging components is done during coding and online operation, to minimize
the wastages.
Ø After
packing the wastage of packing components is calculated on B.P.O.
5.0 QUALITY FORMS AND RECORDS
|
Sheet attached in BMR.
6.0 DISTRIBUTION
|
Ø Head of Operation
Ø Q.A Manager
Ø Production Manager
Ø Q.C Manager
Ø Production Pharmacist
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