1.0 Purpose
1.1 To lay down a procedure for receipt, issuance, storage and handling of solvent.
2.0 Scope
2.1 This SOP shall be applicable for receipt, issuance, storage and handling of solvent at Warehouse
Department of NAME Pharmaceuticals Limited.
3.0 Responsibility
3.1 Warehouse persons and concern people.
4.0 Abbreviations and Definitions
4.1 SOP : Standard Operating Procedure
4.2 Flammable : Sensitive to burn
easily.
5.0 Materials and Equipment
5.1 Mask / Gas Mask (if required)
5.2 Rubber Gloves
5.3 Eye Protector
6.0 Precaution / Health and Safety Considerations
6.1 Use Mask / gas mask (if required), Hand
Gloves, and Eye protector during Handling of flammable
/ hazardous solvent.
6.2 The solvent should issue only in the
dedicated stainless-steel container / HDPE container.
6.3 The solvent should dispense through hand
operated barrel pump and pipe.
7.0 Procedure
7.1 Receipt
7.1.1
After receipt of the consignment every document
should be examined carefully as per checklist:
- Whether
the material belongs to us
- Delivery
challan
- Whether
the materials received as per Purchase Order
- Whether
the material received from approved Vendors.
- Mfg.
COA.
7.1.2 Before unloading, store person shall inspect
the vehicle for cleanliness and allow the vehicle for unloading.
7.1.3
Unload the drum in the solvent room and clean
the drums with clean dry cloth damped with potable water.
7.1.4
Store person shall check the Item Name, Batch
No. and Mfg. Name on each drum and note down the gross weight, tare weight and
net weight in physical verification record.
7.1.5
If Mfg. COA is not received with the
consignment, store person shall immediately inform to purchase department.
7.1.6
Store person shall transfer solvent drums in
the solvent room under lock and key and shall be opened only for dispensing,
sampling and cleaning purpose.
7.1.7
Give the acknowledgment to the transporter and
record all the details in Raw Material Receiving Register.
7.1.8
If any discrepancy found, immediately, store person
informed to commercial dept. in written with a copy to QA department for taking
necessary action with the concern
7.1.9
Filled MRR along with the Certificate of
analysis and Invoice copy will be given to QC department as sampling intimation
and for their necessary action and affix QUARANTINE label on each drum.
7.1.10
Sampling of solvent shall be done by QC. After
sampling, QC department shall affix the UNDER-TEST labels of sampled
containers.
7.1.11
After completion of the analysis, QC Person
shall affix the “APPROVED” or “REJECTED” label on the “QUARANTINE” label.
7.1.12
Sample quantity of each consignment shall be
deducted respectively in stock register by store person immediately.
7.1.13
Store person shall segregate the “Approved”
Material.
7.2 Issuance
7.2.1 Store person shall wear safety protective equipment like hand gloves, safety shoe, safety goggles and mask while dispensing of solvent.
7.2.2
Store person and QA person shall check the
label on each drum for details of Approved Label, Mfg date, Exp. date, Material
name and QC reference number.
7.2.3
Remove the solvent with help of stainless-steel
dedicated barrel pump in cleaned, closed, tare SS container/ HDPE container at
the solvent room.
7.2.4
Place the stainless-steel container on weighing
balance and adjust the weight as per required qty. and transfer the balance
qty.
7.2.5
Closed the stainless-steel container properly
with lid, after required quantity of materials is dispensed.
7.2.6
Store person shall note down the gross weight
and net weight in dispensing slip and sign it with date and countersigned by QA
person.
7.2.7
Enter the QC reference no. and net quantity in
raw materials requisition / BMR.
7.2.8
Transfer the drum into the solvent room.
7.2.9
Store person shall keep back all safety
protective equipment to its original place and transfer the barrel pump and
pipe to washing area.
7.3 Storage
7.3.1 Store
the solvent barrel in the solvent room only under lock and key.
7.3.2 Store
each type solvent in solvent room item wise and MRR wise.
7.3.3 If the
material is rejected by QC, segregate the drum from other drums in a solvent
room and tied with red color rope, check rejected label should be affixed on
each drum for waiting disposal or returned to supplier.
7.3.4 Close
the solvent containers tightly after dispensing / sampling.
7.4 Handling
7.4.1 Flammable
solvent drums should be moved using drum trolley and should never be dropped or
rolled over the floor.
7.4.2 Whenever
it is necessary to transfer solvent from the drum into small closed containers,
appropriate handling equipment should be provided to enable the operation to be
carried out with minimum risk of spillage and exposure.
7.4.3 While
opening drums and other containers care must be taken for any excess pressure
in the form of vapor.
7.4.4 Good
ventilation is essential in rooms where flammable solvent are handled to prevent
accumulation of flammable vapors.
7.4.5 Personnel
handling flammable solvent should wear necessary personal protective equipment
including respiratory protective equipment to minimize the risk of exposure.
8.0 Reference Document
8.1 WHO GMP Guideline, trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
- |
11.0 Training
11.1 Training is
required for store officer trained by Head of Warehouse.
