Learn the SOP for Handling and Storage of Raw & Packing Material in pharmaceutical industries. This guide explains quarantine storage, QC approval, FIFO system, rejection handling, and GMP-compliant storage procedures for raw materials and packaging materials.
SOP for Handling and Storage of Raw & Packing Material
The SOP for Handling and Storage of Raw & Packing Material defines the standard procedure followed in pharmaceutical industries to ensure proper identification, storage, and handling of raw materials and packaging materials. Proper storage practices are essential to maintain product quality, regulatory compliance, and adherence to Good Manufacturing Practices (GMP).
This procedure ensures that materials received in the warehouse are inspected, stored in quarantine areas, verified physically, and transferred to approved storage locations only after Quality Control (QC) approval.
1.0 OBJECTIVE
The objective of this SOP for Handling and Storage of Raw & Packing Material is to establish a standardized procedure for:
- Proper identification of raw and packing materials
- Safe unloading and handling of materials
- Maintaining proper storage conditions
- Ensuring GMP compliance
- Preventing contamination, mix-ups, or deterioration
2.0 SCOPE
This SOP applies to the storage and handling of Raw Materials (RM) and Packing Materials (PM) in the Stores Department of pharmaceutical manufacturing facilities.
3.0 RESPONSIBILITY
Stores Assistant / Stores Officer
- Receiving and unloading materials
- Cleaning containers
- Physical verification of materials
- Placing materials in quarantine storage
- Maintaining records
4.0 ACCOUNTABILITY
Head of Department (HOD)
- Ensuring compliance with this SOP
- Monitoring storage conditions
- Reviewing documentation
- Ensuring GMP compliance
5.0 PROCEDURE
5.1 Receipt and Quarantine of Materials
- After receiving materials, the store personnel shall unload them in the staging area.
- Containers shall be cleaned using a vacuum cleaner or dry lint-free cloth.
- Physical verification of materials shall be carried out.
- Materials shall be transferred to the designated quarantine storage area.
- A Quarantine Label shall be affixed to each container.
5.2 Documentation of Physical Verification
The store person shall record observations in:
- Physical Verification Record for Raw Materials (RM)
- Physical Verification Record for Packing Materials (PM)
5.3 Transfer of Approved Materials
- After Quality Control testing, QC shall affix an APPROVED label on containers.
- Store personnel shall transfer materials to the designated approved storage area as per storage conditions.
5.4 STORAGE OF RAW MATERIAL
5.4.1 Cold Storage Materials
If raw material storage temperature is 2°C to 8°C, materials shall be transferred to cold storage and temperature records shall be maintained daily.
5.4.2 Controlled Temperature Materials
If storage condition is below 25°C, materials shall be stored in the Raw Material Store.
5.4.3 Unspecified Storage Conditions
If storage conditions are not mentioned, materials shall be stored in the RM Store under controlled conditions.
5.4.4 Rejected Raw Materials
- Rejected materials shall be shifted to the Rejected Material Area.
- The area shall remain under lock and key.
- A rejected material logbook shall be maintained.
5.4.5 Information to Purchasing Department
The purchasing department shall be informed about rejected materials for further action.
5.4.6 Handling Loose Materials
After dispensing, remaining material shall be tightly closed with nylon thread and placed back into the original container.
5.4.7 Temperature Deviation
If store temperature exceeds limits, the maintenance department shall be informed immediately for rectification.
5.4.8 Disposal or Return of Rejected Materials
Rejected materials shall either be returned to the supplier or destroyed within the factory premises after preparing a destruction note.
5.5 STORAGE OF PACKING MATERIALS
Packing materials shall be stored separately according to type to prevent mix-ups.
5.5.1 Printed Labels
- Store labels product-wise or item-code wise.
- Keep them in cupboards under lock and key.
5.5.2 Printed Packing Materials
- Store cartons and inserts on racks or pallets.
- Maintain item-wise and lot-wise segregation.
5.5.3 Aluminium Foil / PVC / PVDC Film
- Store printed or plain foil in the foil storage room.
- Ensure physical segregation of consignments.
5.5.4 Measuring Caps / Plastic Jars / Containers
- Store items on pallets after QC approval.
- Small consignments shall be kept on racks or pallets.
5.5.5 Issuance of Packing Materials
All packing materials shall be issued to production on a FIFO (First In First Out) basis.
5.5.6 Rejected Printed Packing Materials
Rejected printed packing materials shall be destroyed in factory premises after completing all necessary documentation and approvals.
Frequently Asked Questions (FAQ)
1. What is SOP for Handling and Storage of Raw & Packing Material?
It is a standard procedure used in pharmaceutical industries to manage receiving, identification, storage, and handling of raw and packaging materials.
2. Why are materials kept in quarantine?
Quarantine ensures materials are not used until they are tested and approved by the Quality Control department.
3. What is FIFO in pharmaceutical storage?
FIFO (First In First Out) ensures older materials are used first to prevent expiry and wastage.
4. Who is responsible for material storage?
The Stores Assistant or Stores Officer is responsible for receiving and storing materials.
5. What temperature is used for cold storage?
Cold storage temperature ranges between 2°C and 8°C.
6. What happens to rejected materials?
Rejected materials are stored separately and either returned to the supplier or destroyed.
7. Why are printed labels stored under lock and key?
To prevent label mix-ups which can cause serious regulatory violations.
8. What records are maintained in stores?
Physical verification records, temperature logs, and rejected material records.
9. What is the purpose of quarantine labeling?
It indicates that the material is awaiting QC approval.
10. Why is segregation important in packing materials?
Segregation prevents mix-ups between different products, batches, and consignments.
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