Standard Operating Procedure for Handling and Storing Packed Capsules

Department	Capsule Packaging
SOP No.	SOP/CP/210/2025
Supersedes	SOP/CP/210/2022
Page No.	Page 1 of 5
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to provide guidelines for the proper handling and storage of packed capsules to maintain product integrity, ensure quality, and prevent contamination or damage during storage or transportation.

2. Scope

This SOP applies to the handling, storage, and transportation of packed capsules, ensuring compliance with GMP guidelines and regulatory requirements.

3. Responsibilities

• Packaging Operator: Responsible for placing packed capsules into the designated storage area and ensuring that they are handled with care to avoid damage or contamination.
• Warehouse Personnel: Responsible for the proper storage of packed capsules, ensuring that environmental conditions are monitored, and that capsules are protected from temperature extremes, humidity, and light.
• Quality Control (QC) Team: Ensures that the packed capsules meet quality standards and are stored in appropriate conditions to maintain product quality.
• Production Supervisor: Oversees the handling and storage process to ensure compliance with this SOP and resolves any issues that may arise during handling or storage.

4. Accountability

The Production Manager is accountable for ensuring that packed capsules are handled and stored properly. The QC Manager ensures that all packaging and storage conditions comply with quality standards and regulatory guidelines.

5. Procedure

5.1 Pre-Storage Preparation

Before storing packed capsules, ensure the following:

1. Verify Packaging Integrity
   1. Ensure that the packaging of the capsules (e.g., bottles, blister packs) is intact and properly sealed.
   2. Check that the correct labeling, including product details, batch number, expiry date, and regulatory information, is affixed to the packaging.
2. Check Storage Conditions
   1. Ensure that the storage area is clean, dry, and free of contaminants. The area should be secured and monitored to prevent unauthorized access.
   2. Verify that environmental conditions such as temperature, humidity, and light exposure are within the specified limits for capsule storage.
3. Prepare for Handling
   1. Ensure that all personnel handling the packed capsules are trained in good handling practices to avoid contamination or damage.

5.2 Handling Packed Capsules

Follow these steps for proper handling of packed capsules:

1. Handle with Care
   1. Ensure that packed capsules are handled gently to avoid physical damage to the packaging. Use appropriate tools, such as lifting equipment or trolleys, when moving large quantities of capsules.
2. Inspect Packaging During Handling
   1. Inspect the packaging for any signs of damage during handling. If any defects are found (e.g., broken seals, damaged bottles), take appropriate action to isolate the affected products for further inspection or disposal.

5.3 Storing Packed Capsules

Follow these steps to properly store packed capsules:

1. Store in Designated Area
   1. Place packed capsules in the designated storage area. Ensure that products are organized by batch number, with clear labeling for easy identification.
2. Monitor Environmental Conditions
   1. Monitor temperature, humidity, and light conditions in the storage area regularly to ensure compliance with storage requirements. Adjust HVAC or lighting systems as needed to maintain optimal conditions.
3. Ensure Stock Rotation
   1. Use the FIFO (First-In, First-Out) method to rotate stock, ensuring that older batches are used or shipped first. Keep records of stock movement for traceability.
4. Protect from Contamination
   1. Ensure that packed capsules are stored away from sources of contamination, such as chemicals, moisture, or physical damage. Use protective covers or containment as needed.

5.4 Post-Storage Activities

After storing the packed capsules, ensure the following:

1. Record Storage Data
   1. Document the storage details, including the number of units stored, storage location, batch number, and environmental conditions at the time of storage.
   2. Maintain records of any environmental monitoring data, such as temperature or humidity logs.
2. Ensure Access Control
   1. Ensure that access to the storage area is restricted to authorized personnel only. Implement a sign-in and sign-out system for tracking movement in and out of the storage area.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• FIFO: First-In, First-Out
• BPR: Batch Production Record

7. Documents

1. Annexure 1: Storage Log
2. Annexure 2: Environmental Monitoring Log
3. Annexure 3: Packaging Inspection Report

8. References

• USP <701> – Disintegration of Tablets and Capsules
• Good Manufacturing Practice (GMP) Guidelines
• Regulatory Requirements for Capsule Storage

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 ID	Storage Date	Storage Location	Operator	Comments
Batch 022	07/02/2025	Warehouse A	John Doe	No issues

Annexure 2: Environmental Monitoring Log

Monitoring Date	Temperature	Humidity	Operator	Remarks
07/02/2025	25°C	45%	Jane Smith	Within acceptable limits

Annexure 3: Packaging Inspection Report

Batch ID	Inspection Date	Defects Identified	Corrective Actions	Final Outcome
Batch 022	07/02/2025	None	None	Approved

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for handling and storing packed capsules	QA Head
01/02/2025	2.0	Updated procedures for monitoring environmental conditions	Improvement in storage and handling methods	QA Head