SOP Title: Management of Warehouse
- Objective:
To lay down the procedure for Management of Warehouse in the Warehouse.
- Scope:
This SOP is applicable for Management of Warehouse in the Warehouse.
- Responsibility:
Warehouse Department: To prepare and review the SOP. To follow the procedures for Management of Warehouse as per this SOP.
Quality Assurance Department: To review and approve the SOP and Annexure. To ensure compliance of the procedure.
- Accountability:
Head Warehouse and Head Quality Assurance Department
- Procedure:
- Definitions:
- Packing Material: As per this scope of SOP, Packing materials include, Forming and Lidding foils, Cartons, Corrugated Boxes, Bottles and likewise.
- Raw Material: As per this scope of SOP, Raw materials are defined as Active Pharmaceutical Ingredients, Excipients, Coating materials, Empty Hard Gelatine shells and likewise.
- Disinfectant solutions:
- Prepared 2.5% solution by addition of 2.5 ml of Savlon in purified water to make it up to 100 ml. To be prepared and used freshly and not to be stored. Use the disinfectant for first fifteen days of the month.
- Prepared 2.5% solution by addition of 2.5 ml of Dettol in purified water to make it up to 100 ml. To be prepared and used freshly and not to be stored. Use the disinfectant for second fifteen days of the month.
- Soap Solution: Prepared 2.5 % solution by addition of 2.5 ml of Teapot in purified water to make it 100 ml. To be prepared and used freshly and not to be stored.
- Procedure:
- Definitions:
| 5.2 | Opening and closing of the Department | |
| 5.2.1 | Collect the keys from the Administration Department by signing in the key issuance and receipt register. | |
| 5.2.2 | Enter in to the respective department by following the Entry/Exit SOP. | |
| 5.2.3 | Upon opening the department and all cubicles, following are to be ensured:
a. All lights are switched ‘ON’’, b. All AHU of warehouse area are switched “ON”, c. LAF is switched “ON”. |
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| 5.2.4 | Make a physical inspection of the raw material warehouse area visually and observe for any unusual activity. | |
| 5.2.5 | Make a physical inspection of the packing material warehouse area visually and observe for any unusual activity. | |
| 5.2.6 | Check and record the temperature and humidity values of the different cubicles. | |
| 5.2.7 | Check and record the pressure difference of the cubicles. | |
| 5.2.8 | Switch “ON” the balances and perform the daily calibration. | |
| 5.2.9 | Clean and sanitise the area and arrange for stores activity. | |
| 5.2.10 | Upon closing the department and all cubicles, following are to be ensured:
a. All light are switched ‘OFF’, b. The balances are switched ‘OFF’, d. All AHU of warehouse area are switched “ON”. |
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| 5.2.11 | Follow the change room procedure and deposit the keys to the Administration Department and sign in the register. | |
| 5.3 | Storage of Materials | |
| 5.3.1 | The different areas in Raw Material Store are Under Test Area, Approved Materials Area, Cool Room 1 & 2, Rejected Materials Area and Solvent Storage Area. | |
| 5.3.2 | The different areas in Packing Material Store are, Primary Packing Materials Store, Secondary Packing Materials Store, Tertiary Packing Materials Storage Area, Under Test Area and Rejected Materials Area. | |
| 5.3.3 | Segregate the materials in the respective storage areas on racks or pallets as per storage recommendations. | |
| 5.3.4 | Each rack shall be labelled area wise. For example, Rack Numbers IA, IB, IC for Area I, Rack Numbers IIA, IIB, IIC for Area II, Rack Numbers IIIA, IIIB, IIIC for Area III respectively. | |
| 5.3.5 | Heavy materials are to be stored on lower platforms of every rack and lighter materials to be stored on the upper platforms of every rack.
NOTE: No materials are to be stored on the top of racks. |
|
| 5.3.6 | Each pallet is labelled in continuous serial numbers like, 1, 2, 3…. and so on. | |
| 5.3.7 | The materials are placed on clean pallets and the pallets can be moved around based on arrangement needs. | |
| 5.3.8 | Every month physically check the racks and pallets for rack labels, pallet count, damage and likewise. | |
| 5.4 | Retest, Expired and Rejected Materials | |
| 5.4.1 | Retest materials should be identified 15 days prior to the retest date as per COA. Submit the Sampling Intimation Slip to the Quality Control Department. | |
| 5.4.2 | Shift the retest material to the Under Test Area and label as ‘QUARANTINE’ | |
| 5.4.3 | Based on re-test COA if the material is ‘APPROVED’, shift it to the respective storage area with an appropriate complying label of Quality Control Department. | |
| 5.4.4 | Based on re-test COA, if the material is ‘FAILED’, shift it to the Rejected Materials Area with an appropriate Rejected label. | |
| 5.4.5 | Expired materials should be identified and intimated to QA and Purchase Department prior to the expiry date as per COA. | |
| 5.4.6 | Shift the expired materials to Rejected Materials Area for further action. | |
| 5.5 | Destruction of rejected materials | |
| 5.5.1 | All the materials collected in the Rejected Materials Area are to be sent to the scrap yard area and to be kept in dedicated “material for disposal area” at the end of every month after approval from QA Department. | |
| 5.5.2 | Fill the Material Destruction Note for destruction of materials. | |
| 5.5.3 | All raw materials which are to be destroyed shall be labelled as ‘HAZARDOUS WASTE’ and packing materials to be labelled as ‘NON HAZARDOUS WASTE’. | |
| 5.5.4 | The materials transferred to the scrap yard are entered in Material Destruction Register. | |
| 5.6 | Monthly Stock Audit | |
| 5.6.1 | At the end of every month, physical stock is verified against the Stock Register for Raw Materials and for Packing Materials. | |
| 5.6.2 | Check the used material container stock and unused container material stock. Check for the count of unused containers and weight of used containers. | |
| 5.6.3 | If any discrepancy is observed in the stock count or weight, inform the Head Warehouse and Head Quality Assurance. | |
| 5.6.4 | Prepare a monthly stock statement and submit one copy to the Purchase Department. | |
| 5.7 | Cleaning and Sanitation | |
| 5.7.1 | Daily cleaning is performed on all floor accessible surfaces using vacuum cleaner (if applicable), soap solution, lint free cloth moistened with water and disinfectant solution. | |
| 5.7.2 | Weekly cleaning is performed additionally on racks, pallets ceiling, walls, light fixtures and glass windows using dry lint free cloth then moistened with soap solution, finally with disinfectant solution.
Note: The cleaning may be performed as and when required as per the need of area. |
|
| 5.7.3 | Monthly cleaning is performed additionally on supply and returns air grills, doors, switch boards, windows etc. using dry lint free cloth followed by moistened with soap solution, finally with disinfectant solution. | |
| 5.7.4 | The area can be additionally mopped with soap solution and disinfectant solution as and when necessary. | |
| 5.7.5 | Unused and / or used cleaning solutions must be drained at the end of the day. The containers used for cleaning must be washed at the end of the day with water, soap solution and finally with disinfect disinfectant solution. | |
| 5.7.6 | All the unused plastic bins and S.S. cage must be wiped with a lint free cloth moistened with purified water at the end of day. | |
| 5.7.7 | Maintain cleaning and sanitization record of Warehouse Department specified for particular area. |
- Abbreviation:
| Abbreviation | Expansion |
| SS | Stainless Steel |
| ml | Millilitre |
| COA | Certificate of Analysis |
| AHU | Air Handling Unit |
| % | Percent |
| LAF | Laminar Air Flow |
| RM | Raw Material |
*Note – Ready to use SOP available in “DOWNLOAD” Section.