Standard Operating Procedure for storage of Raw Material and Packing Materials in warehouse
1. Purpose
To provide a standard operating procedure for storage of Raw Material and Packing Materials in warehouse.
2. Scope
The scope of this SOP is applicable for storage of Raw Material and Packing Materials in warehouse at [company name].
3. Responsibility
Warehouse person: Storage of Raw Material and Packing Materials in warehouse
Warehouse supervisor: Checking of material storage as per required storage condition
Warehouse head: Overall responsibility to ensure compliance to the procedure
4. Definitions
Storage conditions as per different pharmacopoeia:
| Storage Condition | Pharm. Eur. | WHO | USP | JP |
| Frozen/ deep-freeze | > -15°C | -20°C | – | – |
| Refrigerator | 2°C – 8°C | – | – | – |
| Cold | 8°C – 15°C | 2°C – 8°C | <8°C | 1°C – 15°C |
| Cool | 8°C – 15°C | 8°C – 15°C | 8°C – 15°C | – |
| Room temperature | 15°C – 25°C | 15°C – 25°C | temperature prevailing in a work area | 1°C – 30°C |
| Controlled room temperature | – | – | 20°C – 25°C excursions between 15°C and 30°C are allowed | – |
| Ambient temperature | – | 15°C – 25°C or 30°C depending on climatic conditions | – | – |
5. Procedure
1. Storage of material in the warehouse is the next step after material is successfully received and goods inward is done in the material management software.
2. The received material must be storage as per applicable storage condition for the material. Material shall be handled using Pallet Truck for proper handling and to prevent damage.
Hand Pallet Truck
3. Material shall be stored as per labeled claim/ storage condition defined on the container label.
4. In case of material storage condition is not specified on the label, it shall be verified on the Certificate of Analysis for storage condition of the material.
5. For the materials, where storage condition is not provided by manufacturer on Certificate of Analysis as well as in the certificate of analysis, list of storage condition shall be maintained as per format for storage condition list.
6. Following steps shall be followed to maintain the storage condition list.
6.1 Stability data of material shall be requested from the material manufacturer and based on the long term stability condition; material storage condition shall be decided.
6.2 In case, sufficient data are not available, pharmacopoeia can be referred to identify the material storage condition.
6.3 In case, there is no data and reference available, material shall be stored < 25 Deg. C.
6.4 Material shall be stored in the warehouse as per defined storage condition area or room. The location within the room shall be decided based on temperature mapping study.
6.5 No material shall be stored at the area within the room or storage facility, which is not covered during the mapping study. For example, material shall not be stored in room walkway or corridor if the room walkway or corridor is not covered during the mapping study.
7. Storage of Capsule shell: Capsule shells are sensitive to humidity condition in addition to the temperature requirement. Capsule shell requires humidity control at lower as well as upper level. Hence, capsule shell shall be stored as designated storage facility with humidity control.
8. Storage of cold chain materials (2-8 Deg. C, -20 Deg. C, and – 80 Deg. C.): As soon as cold chain material received in the facility, before unloading the material, all the necessary material receipt documentation shall be completed. After unloading the material from the transporter’s vehicle, any necessary checking needs to be done, shall be completed material shall be transferred in the warehouse designated storage facility within 30 minutes [Note: study data for more than 30 minutes excursion should be available from material manufacturer]. In case any material does not have any supporting information for allowed excursion, material shall be received with passive storage facility to maintain the temperature end to end.
9. Material shall be stored in segregated manner. Different batch of same material shall be stored on different pallets. Different material shall be stored on different pallet.
Plastic Pallet
10. Material shall be store in such a manner that, it will prevent possibility of contamination and mix-ups.
11. Material shall be stored off the floor to enable cleaning of floors.
12. Material storage location shall be maintained through material management software.
13. Controlled substance shall be stored in lock and key. The lock and key shall be maintained by authorized personnel only.
14. If the raw material damaged during storage, handling and exposed to environment, information shall be given to QA for observation and disposition decision regarding the material.
15. Material shall be segregated as per its status of approval. Quarantine/ under test, approved and rejected materials shall be stored separately.
16. Rejected material shall be stored under lock and key. Key should be available with Quality Assurance person. It shall be ensured that rejected material shall not be accidentally used or misused.
17. Solvent shall be stored is well ventilated area to prevent any accident. Arrangement shall be made to ensure that static charge should not be generated and if generated, immediately it gets discharged.
18. Solvent and liquid shall be stored on Spill Pallets to ensure that if any spillage occurs, it can be easily contained and prevent spreading in entire storage area and prevent possibility of accident.
19. Storage of Packaging material:
20. Packaging material shall be stored as per storage condition recommended by manufacturer.
21. Following packing material shall be stored < 25 Deg. C, or as recommended by manufacturer:
21.1 Aluminum foils
21.2 Film PVC
21.3 Film PVC – PVDC coated
21.4 Polyethylene bags
21.5 Cotton pharmaceuticals
21.6 HDPE closures
21.7 Silica gel canister
21.8 Vials
21.9 Rubber stoppers
21.10 Pre sterilized ophthalmic bottle
21.11 Nozzle
21.12 Caps
21.13 Flip off seals
21.14 Pre filled syringe
22. Care should be taken while storage of silica gel canister as it is very much sensitive to moisture.
23. Similarly, pre-sterilized material shall be stored to ensure that sterility of material container should not be compromised.
24. The printed packing materials shall be stored in lock and key under safe and secure area.
6. Frequency
Storage of raw material and packing material
7. Formats
- Format for storage condition of material
| Sr. No. | Material Name | Pharmacopoeial grade | Storage Condition | Reference document |