Standard Operating Procedure for Storage of Intermediate Products in Tablet Manufacturing

Department	Tablet
SOP No.	SOP/TAB/048/2025
Supersedes	SOP/TAB/048/2022
Page No.	Page 1 of 6
Issue Date	11/10/2025
Effective Date	16/10/2025
Review Date	11/10/2026

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the proper storage of intermediate products during tablet manufacturing. Proper storage conditions are essential to maintaining the quality, stability, and integrity of intermediate products before they undergo further processing.

2. Scope

This SOP applies to the storage of all intermediate products, including granules, blends, and uncoated tablets, during the manufacturing process. It covers storage conditions, handling procedures, and inventory management to ensure that intermediate products are properly stored before they move to the next production stage.

3. Responsibilities

• Manufacturing Personnel: Responsible for ensuring that intermediate products are stored according to the specified conditions, with proper labeling and inventory tracking.
• Quality Control (QC): Responsible for performing periodic checks to ensure that the storage conditions meet the required specifications and for reviewing product quality.
• Quality Assurance (QA): Ensures that all storage procedures are in compliance with GMP regulations and verifies that records are accurate and complete.
• Warehouse Personnel: Responsible for maintaining the storage environment, ensuring that it is clean, organized, and secure, and that intermediate products are stored in compliance with the SOP.

4. Accountability

The Production Manager is accountable for ensuring that intermediate products are stored under the proper conditions during the manufacturing process. The QA Manager is responsible for overseeing compliance with this SOP and ensuring that all related documentation is reviewed and maintained.

5. Procedure

5.1 Storage Conditions

1. Ensure that the storage area is clean, dry, and free from any potential sources of contamination, including dust, moisture, and pests.
2. Control the temperature and humidity within specified ranges for the storage of intermediate products. Typical conditions include a temperature range of 20°C to 25°C and a relative humidity of 30% to 60%, unless otherwise specified.
3. Ensure proper ventilation in the storage area to prevent the accumulation of excess heat and moisture.
4. Maintain lighting that allows for clear visibility of stored products and proper inspection.

5.2 Labeling and Identification

1. All intermediate products must be labeled clearly with product details, including the batch number, storage date, product type, and any relevant handling instructions (e.g., “Store in cool, dry place”).
2. Ensure that the labels are legible and securely attached to the containers to prevent misidentification.
3. Use a unique identification number or barcode to facilitate easy tracking and retrieval of intermediate products during storage and when needed for further processing.

5.3 Storage Practices

1. Store intermediate products in containers that are properly sealed to protect them from contamination and environmental exposure.
2. Place containers on clean, dry pallets to prevent contact with the floor and ensure proper airflow around the products.
3. Ensure that the containers are stacked in a stable manner to prevent damage and allow for easy access to all stored products.
4. Follow the First In, First Out (FIFO) principle when storing and using intermediate products to ensure that older batches are used first and do not exceed their shelf life.

5.4 Monitoring and Inspection

1. Inspect the storage area regularly to ensure compliance with the specified storage conditions. Record temperature and humidity readings at least once a day and log the data in the storage log (Annexure-1).
2. Check stored intermediate products for any signs of damage, contamination, or degradation. If any issues are detected, immediately notify QA and investigate the cause.
3. Perform periodic sampling and testing of stored intermediate products to verify that they maintain their quality and meet the required specifications.

5.5 Handling and Transfer

1. When transferring intermediate products to another processing area, ensure that they are properly handled to avoid contamination, spillage, or damage. Use clean, sanitized containers and tools for transfer.
2. Document each transfer in the batch record (Annexure-2), noting the date, personnel involved, and any relevant product details.
3. Verify that the product is being transferred to the correct processing area and that all relevant paperwork is completed before the transfer is carried out.

5.6 Waste Management

1. If intermediate products are found to be damaged, contaminated, or no longer suitable for use, they must be properly disposed of according to the facility’s waste management procedures.
2. Ensure that any waste generated during the storage or transfer of intermediate products is disposed of in compliance with environmental and safety regulations.

5.7 Documentation and Record-Keeping

1. Maintain all records related to the storage of intermediate products, including batch numbers, storage dates, temperature and humidity logs, inspection results, and any deviation reports in the batch record (Annexure-2).
2. Ensure that all records are reviewed by QA personnel to verify compliance with the SOP before storage is completed.
3. Keep records secure and readily accessible for audits, inspections, and traceability purposes.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Storage Log (Annexure-1)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Storage Log

Batch Number	Product Type	Storage Location	Temperature (°C)	Humidity (%)	Inspection Date	Comments
Batch 001	Granules	Storage Room A	22	45	01/10/2025	No issues
Batch 002	Blended Tablets	Storage Room B	23	50	02/10/2025	Humidity slightly high

Annexure-2: Batch Record

Batch Number	Product Type	Storage Date	Transferred To	Quantity	Comments
Batch 001	Granules	01/10/2025	Blending Room	100 kg	No deviations
Batch 002	Blended Tablets	02/10/2025	Compression Room	75 kg	Minor delay in transfer

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Storage Procedures	Improved Storage Management	QA Head