SOP on Receipt and Storage of Packaging
Materials
1.0 Purpose: This SOP describes the procedure
for receipt and storage of packaging materials.
2.0 Scope: This SOP applies to all
the packaging materials (i.e. primary packing and secondary packing) used in
the packaging of drug formulations.
3.0 Responsibilities: 1. The Packing
Materials Store supervisor is responsible for the receipt, proper storage and
records thereof.
2. The
store supervisor is also responsible for sending requests to Quality Control
Laboratory for sampling and testing of the materials received.
4.0 Materials and Equipment: As
required.
5.0 Procedure:
5.1.0 Policy
5.1.1. The packing materials will be held in
quarantine till they are approved and released
by the Quality Control Department.
5.1.2. The packing materials approved and released
by Quality Control Department only will be accepted by the store supervisor.
5.2.0
Receipt
of Materials :
5.2.1. Materials will be received from the approved suppliers against a purchase
order sent by the purchase department.
5.2.2. Materials from local or outstation suppliers will be received by the
concerned supervisor on all working days during normal working hours.
5.2.3
On receiving the information,
packing materials store supervisor will receive the materials after checking
the delivery Challan for following details:
*Name of the material supplied.
*Supplier’s name & address.
*Quantity supplied.
*Purchase order number & date.
No
material will be accepted if the accompanying Challan does not mention the
above details.
5.2.4
In case any discrepancy is
observed on checking up the delivery challan with purchase order, the stores supervisor
will report the same to the purchase department and will not take any delivery
of the goods unless the discrepancy is clarified to satisfaction.
5.2.5
The packaging materials will be
stored in “Under Test” area till released by Quality Control Department.
5.2.6
The receipt of the packaging materials
will be entered in an electronically maintained inward receipt register for packaging
materials.
5.2.7
A Goods-in Inspection Report
(GIR) form will be completed.
5.2.8
The store supervisor will prepare
a requisition form for testing and send to the Quality Control Department.
5.2.9
The Quality Control Department
will arrange to draw the samples of packaging materials as per SOP.
5.2.10 n case the material is rejected by the Quality Control Department because
of it non-compliance with the prescribed specifications rejected label will be
super-imposed on the “under test” labels of each container / package covering
the words “under test.”
5.2.11 The store supervisor will arrange to get physically transferred all the
containers / packages of the material to the area reserved for the storage of
rejected materials.
5.2.12 The purchase officer will immediately arrange to return the rejected
unprinted material and the printed material is destroyed by shredding or
suitable other means.
5.2.13 In case the material is approved by the Quality Control, signed approved
label will be super-imposed on the “under test” labels of each container/package
covering the words “under test.”
5.2.14 The store supervisor will arrange to physically transfer all the
containers/packages of the material to the area reserved for the storage of
approved materials.
5.2.15 In case the material received comprises of more than one lot, samples
will be drawn from each lot. If some lots are approved by the Quality Control
and others are rejected, the stores supervisor will take action as indicated above
in respect of containers/packages of the approved or rejected lots.
5.2.16 Entries of the receipt of the approved materials should be made in the
registers and other records maintained by the stores.
5.3 Storage
5.3.1 Primary Packaging Materials like aluminium
foil, polyglassine foil, PVC foil etc. requiring to be stored in a relatively cool
place shall be stored at a temperature not more than 270C.
5.3.2
The store supervisor will maintain records of
temperature.
5.3.3
All the materials will be stored in such a
manner so as to permit issue of the materials on the “first in, first out” basis.
5.3.4
Materials should be stored in
such a manner in any given area on racks or pallets so that they can be easily
traced. Racks bear identity numbers.
5.3.5
No two materials of similar
printing should be stored together so as to prevent issue of wrong materials.