SOP Guide for Pharma

SOP for Ensuring Proper Storage Conditions for Unapproved Raw Materials – V 2.0

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SOP for Ensuring Proper Storage Conditions for Unapproved Raw Materials – V 2.0

Standard Operating Procedure for Ensuring Proper Storage Conditions for Unapproved Raw Materials

Department Quality Assurance / Warehouse / Quality Control
SOP No. SOP/RM/091/2025
Supersedes SOP/RM/091/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for ensuring proper storage conditions for raw materials that have not yet been approved for use. The purpose is to maintain material integrity, prevent contamination, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials received at the facility that are pending approval, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials. It covers materials stored in quarantine awaiting quality control (QC) testing, documentation verification, and final release or rejection decisions.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that all unapproved raw materials are stored under proper conditions in compliance with regulatory standards. The Warehouse Manager is responsible for the physical handling and storage of these materials.

5. Procedure

See also  SOP for Handling Biodegradable and Environmentally Sensitive Raw Materials in Quarantine - V 2.0

5.1 Storage Requirements for Unapproved Raw Materials

  1. Quarantine Area Designation:
    • Unapproved materials must be stored in a physically segregated area designated for quarantine.
    • The quarantine area must be clearly marked with “Unapproved Materials” signage and have restricted access.
  2. Environmental Control:
    • Maintain temperature, humidity, and other environmental conditions within specified limits for each material type.
    • Monitor environmental conditions regularly and document in the Environmental Monitoring Log (Annexure-1).

5.2 Labeling and Identification of Unapproved Materials

  1. Labeling Requirements:
    • All unapproved raw materials must be labeled with the following information:
      • Material Name
      • Batch/Lot Number
      • “Unapproved” Status
      • Date of Receipt
      • Storage Conditions (if applicable)
  2. Color Coding:
    • Use color-coded tags to easily identify unapproved materials. For example:
      • Red tags for materials pending QC testing
      • Yellow tags for materials pending documentation review

5.3 Monitoring Storage Conditions

  1. Daily Monitoring:
    • Warehouse personnel must check storage conditions daily, including temperature, humidity, and physical integrity of the storage area.
    • Document findings in the Daily Storage Condition Log (Annexure-2).
  2. Deviation Handling:
    • Any deviations from specified storage conditions must be documented in the Deviation Log (Annexure-3) and reported to QA immediately.
    • Investigate deviations and implement corrective actions as needed.

5.4 Handling Special Categories of Unapproved Materials

  1. Hazardous Materials:
    • Store hazardous unapproved materials in compliance with safety regulations and Material Safety Data Sheets (MSDS).
    • Ensure proper labeling, use of personal protective equipment (PPE), and secure storage conditions.
  2. Temperature-Sensitive Materials:
    • Maintain cold chain conditions for temperature-sensitive unapproved materials.
    • Document temperature logs in the Temperature-Sensitive Material Log (Annexure-4).
See also  SOP for Fire Safety Precautions in Raw Material Storage Areas - V 2.0

5.5 Documentation and Record-Keeping

  1. Material Storage Records:
    • Maintain detailed records of all unapproved raw materials, including storage conditions, batch information, and movement logs.
    • Record all entries in the Unapproved Material Storage Log (Annexure-5).
  2. QA Review and Audits:
    • QA must periodically review storage practices and documentation for compliance.
    • Document audit findings in the Compliance Audit Log (Annexure-6).

5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All warehouse and QA personnel must be trained on proper storage procedures for unapproved raw materials.
    • Document training sessions in the Training Log (Annexure-7).
  2. Compliance Monitoring:
    • QA conducts regular inspections to ensure ongoing compliance with this SOP and regulatory requirements.

6. Abbreviations

7. Documents

  1. Environmental Monitoring Log (Annexure-1)
  2. Daily Storage Condition Log (Annexure-2)
  3. Deviation Log (Annexure-3)
  4. Temperature-Sensitive Material Log (Annexure-4)
  5. Unapproved Material Storage Log (Annexure-5)
  6. Compliance Audit Log (Annexure-6)
  7. Training Log (Annexure-7)

8. References

9. SOP Version

Version: 2.0

See also  SOP for Receiving Raw Materials from Different Manufacturers of the Same API - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Time Temperature (°C) Humidity (%) Recorded By
01/02/2025 09:00 AM 25°C 45% Ravi Kumar

Annexure-2: Daily Storage Condition Log

Date Material Name Batch Number Storage Condition Status Checked By
01/02/2025 API-X API-X-2025-001 Within Specified Limits Sunita Sharma

Annexure-3: Deviation Log

Date Material Name Batch Number Deviation Description Reported By
02/02/2025 API-X API-X-2025-001 Temperature Spike to 30°C Ajay Singh

Annexure-4: Temperature-Sensitive Material Log

Date Material Name Batch Number Storage Temperature (°C) Recorded By
01/02/2025 Solvent-Y SLV-Y-2025-002 5°C Ravi Kumar

Annexure-5: Unapproved Material Storage Log

Date Material Name Batch Number Storage Location Stored By
01/02/2025 API-X API-X-2025-001 Quarantine Area A Ravi Kumar

Annexure-6: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
04/02/2025 Storage Compliance Audit Temperature Monitoring Gaps Updated Monitoring Procedures Anjali Mehta

Annexure-7: Training Log

Date Training Topic Trainer Attendee Name Signature
05/02/2025 Proper Storage of Unapproved Raw Materials QA Manager Sunita Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated Storage Protocols for Unapproved Materials Regulatory Compliance QA Head
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