SOP on Receipt & Issue of raw & packaging materials in the material Stock Card (Top & Bottom Card).
Objective : To delineate the procedure for the receipt, storage and approval / rejection of Raw and Packaging Materials in the Material Stock Card.
Scope : This SOP is applicable for raw and packaging material warehouse in formulation plant.
Responsibility: Officer / above Warehouse is responsible for implementation of SOP.
Accountability: Head- Warehouse shall be accountable for compliance of SOP.
Procedure:
Receipt of the Material: On receipt of material, security personnel checks the delivery documents and ensure that consignment is meant for own company only. In case of any discrepancy vehicle shall not be allowed to enter into premises.
After confirmation of the address, security informs Warehouse department and send the delivery documents for verification.
Warehouse Personnel shall collect the documents and check the following in the delivery documents.
Check the correctness of company address on the delivery documents.
Check that the vendor is approved as per current version of Approved Manufacturer / Vendors List, including vendor address.
Check the availability of Vendor Certificate of Analysis copy.
Check the purchase order number is mentioned on the delivery documents.
Ensure the description of the material in purchase order tallies with that mentioned in delivery documents.
In case of any discrepancies observed, the same shall be informed to HOD (Store) & Purchase department for corrective action (if any), and vehicle shall not be allowed to enter into the factory premises till the corrective action taken.
After verification Warehouse sends back the documents to security and instructs to make the entry in security inward.
Security personnel shall record the entry of material and put gate entry stamp on the delivery documents and allows the vehicle to enter into the premises along with the documents.
The documents related to Raw materials & Packing materials are incorporated in Material Inward Register for Raw Material & Packing Material as per SOP.
The MRIN (Material Receipt & Inspection Note) is created after the receipt of Q.C. report.
Pre-Unloading Activities
On arrival of the vehicle carrying material at unloading area, carry out the following activities.
Instruct the vehicle driver to stop the engine to avoid carbon spillage from silencer, till completion of de-dusting and transfer of materials to staging area.
Warehouse personnel ensure to check the vehicle for material other than mentioned in the delivery documents in order to avoid mix-ups.
Ensure the material receiving area is clean before unloading the material.
Ensure the cleanliness of the pallets on which the material to be unloaded.
Ensure the cleanliness and working condition of the handling equipment and vacuum cleaner.
Ensure the air curtain is switched on.
Before starting the De-dusting operation ensure the inside door is closed.
Ensure the weighing balance is calibrated.
Note: Ensure that at a time only one material is unloaded. .
Unloading Activities:
Open the door of receiving bay area to receive the material. Ensure that inside door is closed.
Ensure to unload the material safely from the vehicle onto the clean pallets.
Warehouse personnel checks the material container for external identification label for the following details and fill the checklist.
Material Name (To match with COA & Company Specifications)
Supplier/Manufacturer Address. (To match with Approved Vendor list).
Batch Number/Lot number.
Manufacturing date (if available on the container/ COA copy.)
Expiry date / Retest date. (As available on the container/ COA copy).
Check any storage conditions are mentioned on the container label.
Deface the supplier’s / Manufacturer’s approved label available on the container / pack.
Ensure to physically verify all the unloaded containers / packs, identification and seal (quantity and condition) as per Delivery documents. If it is tallied, acknowledgement is given to the vehicle driver by putting the stamp and sign on a copy of the delivery documents.
In case of any shortage, damage, breakage or tampered containers (occurred due to the fault of transporter) is received, the same shall be mentioned on all copies of delivery documents and signature of the driver shall be taken as a confirmation and intimation is given to quality assurance department through check list, and next action is decided after due consultation with Quality Assurance Department.
De-Dusting Procedure
Proceed for de-dusting of containers as below.
Transfer one container at a time, on the clean pallets for de-dusting Operation.
Clean the external surface of the container by using the Vacuum cleaner, operating the vacuum cleaner as per SOP no. WH-SG-001.
Rotate the container sideways and ensure the vacuum suction of all external surfaces of top and bottom during the de-dusting.
Clean the container with lint free duster.
After cleaning and de- dusting, ensure to segregate the material as per batch / lot wise. Ensure to handle the containers carefully to avoid damage to the seal during de-dusting.
Post de-dusting procedure : Ensure that out side door of air lock room is closed.
Ensure the Waste generated in the de-dusting area is disposed off in dustbin provided.
Ensure to close the inside door of the airlock room.
After completion of receiving operation, ensure the cleaning of receiving area.
Weighing Procedure: Transfer the containers and other suitable means batch / lot wise to the weighing balance.
Check for the cleanliness of the balance and ensures the routine calibration of the same.
Switch on the balance wait till zero is displayed.
Follow the below mentioned weighing table plan for verification of the received containers.
| S.No. | Type of materials | No. Of container to be weight verified |
| 01 | Active Pharmaceutical Ingredients | 100 % |
| 02 | Excipients | 100 % |
| 03 | Cartons / Labels / Shippers | Number of packs counting & weighing of one pack for content |
| 04 | Aluminium Seal Boxes | Number of shippers, content in one shipper and weighing one bag |
| 05 | Rubber Stoppers Boxes | Number of boxes & content in one box and weight in one box |
Note: For any additional five containers received verify weight for the one container.
Quarantine Procedure: Transfer the material to Quarantine area and store the material as per recommended storage conditions.
Ensure the cleanliness of the storage pallet.
Stack the materials in designated storage pallet.
After selecting the required series Prepare GRN for Raw material / Packing material for each batch of the raw material received in one consignment.
On the same GRN, QC assigns one unique A R. No. / Lot No. This AR No. will continue for one year from January to December.
Record the details of Material in Material Stock Card (Top Card).
Prepare the Quarantine label and affix on each container of raw material.
Send Goods Received Note (GRN) to Quality Control department.
Co-ordinate with Quality Control chemist for batch wise sampling as per SOP for Sampling of the raw material.
Ensure the Quality Control chemist affixes “Under Test label”, on the entire container as per SOP.
Ensure under test Labels are duly filled and signed.
Ensure the sampled containers are sealed properly and placed in its respective location.
Approval / Rejection:
After analysis, Quality Control sends back the GRN to Warehouse indicating the material status and mention the Quality Control sampled quantity, status of approval / rejection along with the Certificate of Analysis.
Quality control chemist Affixes Approved / Rejected label on Under Test label on all the containers / packs.
Quality control returns the hard copy of the GRN indicating the result of analysis along with the Certificate of Analysis.
Ensure all the status labels are filled properly with date and signatures.
Enter the approved quantity into material stock card.
Transfer the material to designated approved area and store under recommended storage conditions.
File the following documents with each GRN.
Goods Received Note
Certificate of Analysis
Delivery Documents.
Note: In case of rejection, shift the material to the rejected area having lock and key facility, just after the receipt of the REJECTION NOTE and affixing the REJECTED labels on the container. Inform to Purchase department for return to vendor along with proper documents.