SOP Title: Receipt of Raw Materials and Packing Materials
- Objective:
To lay down procedure for receipt of Raw Material and Packing Materials in the Warehouse.
- Scope:
This SOP Applicable to Raw materials and Packing Materials in the Warehouse received from the suppliers.
- Responsibility:
- Warehouse Department: To prepare and review the SOP. To follow the procedures laid down for receipt and handling of raw materials and Packing materials as per this SOP.
- Purchase Department: To share a copy of the Purchase Order to the warehouse department and to collect the GRN copy from the warehouse
- Quality Control Department: To receive the Sampling Intimation Slip and GRN copy from the Warehouse Department
3.4 Quality Assurance Department: To share the Approved Vendor List and to handle discrepancies during receipt of materials. To review and approve the SOP and Annexure
- Accountability:
Head, Warehouse Department and Head, Quality Assurance Department
- Procedure:
- Definitions:
- In-warding: Receipt of raw materials and packing materials from suppliers and / or other Sites.
- Raw Materials: As per this scope of SOP, Raw Materials include, Active Pharmaceutical Ingredients, Excipients, Colours, Coating Agents, Hard Gelatin Capsules and likewise.
- Packing Materials: As per this scope of SOP, Packing materials include, Forming and Lidding foils, Cartons, Corrugated Boxes, Bottles and likewise.
- Approved Supplier List: List of approved manufacturers, vendors and / or suppliers for raw materials and packing materials as her by Quality Assurance department
- MODVAT: Modified Value Added Tax, which is related to government excise duty and taxation policies to be followed during procurement.
- Procedure
- Definitions:
| INWARDING | ||
| 5.2.1 | On arrival of the material at the Warehouse receiving bay, receive the documents from the transporter at the Warehouse office | |
| 5.2.2 | Refer the received material against the Purchase Order as received from the Purchase Department. In case of any discrepancy, consult the Purchase Department | |
| 5.2.3 | Check whether the Supplier is an approved supplier from the approved supplier list provided by Quality Assurance. | |
| 5.2.4 | Confirm that the Delivery Challan and Lorry Receipt contain the following details required for the materials.
a. Suppliers full name and address. b. Manufacturer’s name c. Check Suppliers Drug Licence No. (if applicable). d. Name of material in full. e. Manufacturer’s Batch No. / Lot No. f. Mfg. Date and expiry date or retest date. g. Quantity/ weight per pack, per batch and total quantity. h. Check the COA availability i. Excise invoice for MODVAT (if applicable). j. Any additional details as mentioned in PO |
|
| 5.2.5 | Upon ensuring the steps 5.2.2 upto 5.2.4 proceed for unloading of the raw materials. If any discrepancy in inform Head Warehouse prior to unloading. | |
| UNLOADING | ||
| 5.2.6 | Open the outside shutter of the Warehouse receiving bay to unload the raw materials and Packing materials. Ensure that the inside shutter of the Warehouse receiving bay is closed during the unloading operation | |
| 5.2.7 | Unload the material on first come first basis and on priority whenever necessary. | |
| 5.2.8 | Before unloading ensure the packages to have identification labels, indicating the item, batch number, quantity packed, date of manufacturing and the name of manufacturer as per the Delivery Challan and Lorry Receipt. Check that the packages have not been tampered or damaged during transit. | |
| 5.2.9 | Before unloading material, the Checklist for Raw Materials / Packing Materials Receipt should be filled and filed. | |
| 5.2.10 | If the received raw material or packing material and Delivery Challan and Lorry Receipt match as per checklist give instructions to unload the materials | |
| 5.2.11 | Warehouse person to verify each drum / bag / rolls / box and likewise having proper labelling of each container and also check the intactness of the consignment | |
| 5.2.12 | Segregate the damaged items received in the consignment. | |
| 5.2.13 | If the damage is extensive then put an external Polythene bag and seal the bag so that there is no further spillage. | |
| 5.2.14 | In case of Raw material or Packing material if there is damage to the bag or container, close the damaged bags and containers with BOPP tape. | |
| 5.2.15 | Store the damaged bags / containers / packs on a pallet in the ‘Holding area’ in the receiving bay separately. | |
| 5.2.16 | Record the discrepancy in Material Discrepancy Register as per Annexure and intimate QA for inspection and wait for Quality assurance comments. | |
| 5.2.17 | If QA report indicate to reject materials, transfer the rejected material with same vehicle by putting remarks on transporter LR copy by taking signature of Driver of vehicles & immediately inform Purchase Department | |
| 5.2.18 | Perform the outer cleaning of the containers / bags of raw materials / packing materials in dedusting area with vacuum cleaner and then with dry lint free cloth | |
| 5.2.19 | Close the outer shutter and open the inner shutter and on air curtain, move the received raw materials or packing materials. Perform the checks as mentioned in step 5.2.4 and stamp as received in the Delivery Challan and Lorry Receipt. | |
| 5.2.20 | The stamped Delivery Challan is retained at the Warehouse and the stamped Lorry Receipt is handed over to the transporter. | |
| SHIFTING | ||
| 5.2.21 | Enter all the received raw materials and packing materials in Raw Material / Packing Material Receipt Register. | |
| 5.2.22 | Shift the materials to respective designated areas. Example, Empty gelatin shells to cold store, Packing materials to primary or secondary packing store, Solvents to solvent store and likewise. | |
| 5.2.23 | In their respective areas, sort the materials batch wise and get the material arranged systematically on clean pallets / racks in the under test area or any specific designated area in the warehouse, so as to ensure maximum utilization of space and easy view of identity labels. Ensure the temperature and humidity is within the limits of NMT 25°C and NMT 60%RH | |
| INTIMATION | ||
| 5.2.24 | Prepare the Goods Receipt Note (GRN). Submit the GRN to purchase department along with excise invoice for Modified Value Added Tax (MODVAT). One copy of the GRN is retained at the warehouse department. GRN is to be prepared and submitted to purchase department, not later than 1 day from the receipt of goods. | |
| 5.2.25 | Intimate the QC for sampling as per Annexure along with one photocopy of the GRN and the Vendor COA for reference. Intimation to the QC department is to be given not later than 2 days from the GRN date. | |
| 5.2.26 | Label (orange coloured) the raw material and packing material as QUARANTINE. |
- Abbreviation
| Abbreviation | Expansion |
| HOD | Head of Department |
| PO | Purchase Order |
| COA | Certificate of Analysis |
| GRN | Goods Receipt Note |
| WHD | Warehouse Department |
| Mfg. Date | Manufacturing Date |
| G. Wt | Gross Weight |
| BOPP Tape | Biaxially Oriented Polypropylene Tape |
*Note – Ready to use SOP available in “DOWNLOAD” Section.