SOP for Receipt and Storage of Raw Materials

OBJECTIVE

To lay down a procedure for the receipt and storage of raw materials in the raw material warehouse.

SCOPE

This procedure applies to the Warehouse Department at PharmaInfo Ltd.

RESPONSIBILITY

Raw material warehouse personnel to follow the procedure.

Warehouse in charge and Beta-Lactam In-Charge to ensure compliance.

PROCEDURE

1. Documents / Material verification:

• The warehouse personnel shall receive the documents like delivery notes/packing lists and certificates of analysis from the transporter.
• Warehouse personnel shall physically verify each consignment before unloading from the truck to ensure that the consignment is not mixed with other materials during transit and there is no contamination.
• In the case of mixed consignment, if there is a damage to one or more containers/bags, the consignments would be segregated and unloaded on pallets lot/batch-wise. These will be verified for any damages.

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• Material damage report would be prepared for all consignments purported to have been contaminated. However, GRN would be raised and the material accepted/ rejected depending on QC report.
• Inform warehouse In-charge of any damage or discrepancy.

2. Receipt of materials:

• Unload the material on pallets in the de-dusting area. Check the containers for any damage and integrity of seals.
• Check each container label against the material delivery note or packing list for details like material name, manufacturer's name, batch number, manufacturing date, expiry date, (if any) quantity, etc.,.
• Clean the container surface using a vacuum cleaner/lint-free cloth at the receipt area (de-dusting area).
• Weigh the containers and verify the gross weight at the receipt area.
• In case of any damaged container is received, fill the Material Damage report (Annexure No.: 1) and get the signature of the transporter.

• If the container is received in damaged condition, transfer the material into another container, or double polybag. Retain the manufacturer label, wherever possible.
• The warehouse in charge shall acknowledge the duplicate copy of the delivery note and hand it to the transporter.
• Enter the details in "Raw Material Quarantine Register. (Annexure No.: 2).

3. Storage of materials:

• After receiving the consignment, arrange the consignment lot/batch-wise on pallets together. To be sampled label (Annexure No.: 3) shall be prepared by Warehouse Personnel. Display the material status label in front of the consignment.
• Material that needs to be stored under a controlled environment shall be moved to a controlled environment Quarantine.
• Enter the material details in "Good's Receipt note (GRN)"
• "Good's Receipt note (GRN)" shall be raised for each lot No. / Batch No. of the consignment in duplicate (QC copy/ Warehouse copy).
• Each GRN shall be identified with a GRN number.

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• Hand over the GRN in duplicate and the supplier's / manufacturer's Certificate of Analysis, if any to the Quality Control department.
• After sampling is done by QC personnel, a "Sampled" label shall be sticked on the containers from which the sample is taken by them. The material shall remain in the Quarantine area.
• The Quantity drawn for sampling by QC shall be entered in the sampling register and duly signed by the QC personnel and warehouse personnel.

4. General instructions

• No fiber-shedding packages (jute bags, jute ropes etc.,) shall be allowed into the warehouse. Received, if any, shall be removed from the pack in the de-dusting area and disposed of.
• No bag shall be tied with jute or shedding ropes/tapes. Plastic tape of suitable size and thickness shall be used for tying the bags.
• Method for closing of opened bags: Air shall be removed from the bag by pressing the empty space. The loose portion of the bag shall be folded and twisted tight, folded to half, and tied firmly using plastic tape. Any dispensing aids shall be immediately cleaned and dried. They shall not be left in the containers.

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ABBREVIATION

Q.A - Quality Assurance

Q.C - Quality Control

SOP - Standard Operating Procedure

No. - Number

W.H - Warehouse

R.M - Raw materials

GRN - Goods receipt note

ANNEXURE

Annexure No.: 1 - Material damage report

Annexure No.: 2 - Raw material quarantine register

REVISION HISTORY

Nil

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