SOP Guide for Pharma

Capsule: SOP for Labeling and Storage of Dispensed Materials – V 2.0

Auditor

Capsule: SOP for Labeling and Storage of Dispensed Materials – V 2.0

Standard Operating Procedure for Labeling and Storage of Dispensed Materials

Department Capsule Manufacturing
SOP No. SOP/CM/003/2025
Supersedes SOP/CM/003/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To define the procedure for the correct labeling and storage of dispensed materials, ensuring compliance with GMP standards and facilitating easy identification and traceability.

2. Scope

This SOP applies to all dispensed materials used in capsule manufacturing, including APIs, excipients, and packaging materials, from the point of dispensing to their storage for further use.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the correct storage of materials, while the QA Manager ensures compliance with all GMP and regulatory requirements.

5. Procedure

5.1 Dispensing and Labeling of Materials

Follow these instructions when dispensing materials and labeling them for storage:

  1. Material Dispensing
    1. Ensure that materials to be dispensed are first verified by the Manufacturing Supervisor for the correct batch and quantity according to the work order.
    2. Ensure that dispensing is performed in a clean and controlled environment to prevent contamination or mix-up of materials.
    3. Once dispensed, verify the material using the batch record and weigh or measure according to the required quantities.
  2. Labeling Materials
    1. Each dispensed material must be labeled with the following information: material name, batch number, quantity dispensed, date of dispensing, and the responsible personnel’s initials.
    2. Labels should be clear, legible, and attached securely to the material containers to ensure visibility and prevent loss of information.
    3. If any discrepancies occur during dispensing or labeling, notify the QA team immediately for further review and action.
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5.2 Storage of Dispensed Materials

Follow these instructions to ensure proper storage of dispensed materials:

  1. Storage Location
    1. Materials should be stored in designated areas that are clearly labeled according to the material type (e.g., excipients, APIs, packaging materials).
    2. Ensure that storage areas are clean, dry, and free from contamination or cross-contamination between different material types.
    3. Materials requiring specific conditions (e.g., temperature-sensitive) must be stored in designated storage units (e.g., refrigerators or freezers) as per the material’s requirements.
  2. Inventory Management
    1. Materials should be stored in a way that allows easy access and minimizes the risk of damage or loss.
    2. Ensure that materials are stored according to FIFO (First In, First Out) to prevent the use of expired or obsolete materials.
    3. Regularly check the inventory levels of stored materials to ensure there is no excess or shortage.
  3. Segregation of Rejected Materials
    1. Rejected materials must be segregated from approved materials and clearly marked as “Rejected” to prevent their accidental use.
    2. All rejected materials must be quarantined until further investigation and resolution are made.
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5.3 Periodic Review and Inspection

Ensure periodic inspections and audits are performed as follows:

  1. Routine Inspections
    1. Conduct routine inspections of stored materials to ensure that labels are intact and legible, and materials are properly stored.
    2. Any discrepancies should be recorded and addressed according to the Corrective and Preventive Action (CAPA) process.
  2. Periodic Audits
    1. QA will perform regular audits to ensure compliance with storage and labeling procedures.
    2. Audits should include random checks of stored materials and verification of labeling accuracy and completeness.

5.4 Handling Non-Conforming or Damaged Materials

If materials are found to be non-conforming or damaged during inspection or storage, follow these steps:

  1. Quarantine the affected materials immediately and label them as “Rejected.”
  2. Record the incident in the Discrepancy Report (Annexure-1) and notify QA for further investigation.
  3. Coordinate with Procurement to resolve the issue (e.g., return, replacement, or disposal).

5.5 Documentation and Record-Keeping

Ensure proper documentation for all labeling and storage activities:

  1. Complete the Material Dispensing Log (Annexure-2) with the material details, quantity dispensed, and the name of the responsible personnel.
  2. Update the inventory management system to reflect the quantity of dispensed and stored materials accurately.
  3. Maintain records of all rejected materials, including the reason for rejection and corrective actions taken, in the Discrepancy Report (Annexure-1).
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6. Abbreviations

7. Documents

  1. Material Dispensing Log (Annexure-2)
  2. Discrepancy Report (Annexure-1)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date Material Name Batch Number Issue Description Corrective Action
02/02/2025 Excipient Material A Batch 12345 Damaged Packaging Returned to Supplier

Annexure-2: Material Dispensing Log

Date Material Name Batch Number Quantity Dispensed Responsible Personnel
03/02/2025 API-123 Batch 67890 500 g John Doe

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 Document Format and Updates Standardization QA Head
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