SOP Guide for Pharma

SOP for Quarantine Procedures for Raw Materials Requiring Special Handling – V 2.0

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SOP for Quarantine Procedures for Raw Materials Requiring Special Handling – V 2.0

Standard Operating Procedure for Quarantine Procedures for Raw Materials Requiring Special Handling

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/082/2025
Supersedes SOP/RM/082/2022
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 handling raw materials requiring special handling during quarantine. This ensures the safe storage, segregation, and management of hazardous, temperature-sensitive, and biologically sensitive materials, in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials that require special handling, including hazardous chemicals, temperature-sensitive materials, biologically active substances, and highly potent compounds, during their storage in the quarantine area.

3. Responsibilities

4. Accountability

The Warehouse Manager is responsible for ensuring safe handling and storage of special-handling materials. The QC Manager ensures proper sampling and testing, while the QA Manager oversees adherence to regulatory requirements and approves deviations.

5. Procedure

5.1 Identification and Classification of Special-Handling Materials

  1. Material Categories:
    • Hazardous Chemicals: Corrosive, flammable, toxic, or reactive substances.
    • Temperature-Sensitive Materials: Materials requiring cold chain management or specific temperature conditions.
    • Biologically Active Substances: Enzymes, cultures, or biologics requiring sterile or biohazard containment.
    • Highly Potent Compounds: Materials with high pharmacological activity requiring containment procedures.
  2. Labeling Requirements:
    • Clearly label all special-handling materials with hazard symbols and handling instructions.
    • Include details like Material Name, Batch Number, Special Handling Instructions, and Storage Conditions.
See also  SOP for Receiving Hazardous Chemicals and High-Risk Raw Materials - V 2.0

5.2 Storage and Segregation Procedures

  1. Designated Storage Areas:
    • Store hazardous chemicals in designated flammable or corrosive cabinets with proper ventilation.
    • Store temperature-sensitive materials in cold rooms, refrigerators, or freezers, with continuous temperature monitoring.
    • Biologically active substances must be stored in sterile, contamination-free environments.
    • Highly potent compounds must be stored in secure, access-controlled areas.
  2. Segregation Requirements:
    • Physically separate incompatible materials to prevent cross-contamination or chemical reactions.
    • Maintain distance between flammable and reactive materials and avoid storing acids and bases together.

5.3 Handling Procedures

  1. Personal Protective Equipment (PPE):
    • Wear appropriate PPE, including gloves, lab coats, face shields, and respirators, based on the material’s hazard classification.
  2. Material Transfer:
    • Use spill-proof, tamper-resistant containers for transporting hazardous and temperature-sensitive materials within the facility.
    • For biologically active materials, use sterile transport containers to maintain integrity.
    • Ensure that all transfer activities are logged in the Material Handling Log (Annexure-1).

5.4 Monitoring and Documentation

  1. Environmental Monitoring:
    • Continuously monitor temperature, humidity, and other environmental parameters for sensitive materials.
    • Record data in the Environmental Monitoring Log (Annexure-2).
  2. Material Inspection:
    • Conduct routine inspections of special-handling materials for signs of degradation, leakage, or contamination.
    • Document inspection results in the Special-Handling Material Inspection Log (Annexure-3).
See also  SOP for Storage of Hazardous Chemicals in Compliance with Safety Regulations - V 2.0

5.5 Handling Deviations in Special-Handling Procedures

  1. Deviation Reporting:
    • Immediately report any deviations from special-handling procedures, such as temperature excursions or packaging damage, to the QA Manager.
    • Document deviations in the Special-Handling Deviation Report (Annexure-4).
  2. Corrective Actions:
    • Investigate the cause of the deviation and implement corrective actions to prevent recurrence.
    • Document corrective measures in the Corrective Action Log (Annexure-5).

5.6 Training and Compliance

  1. Personnel Training:
    • All personnel involved in handling special-handling materials must receive training on specific procedures and safety measures.
    • Document training in the Training Log (Annexure-6).
  2. Compliance Monitoring:
    • QA must conduct periodic audits to ensure adherence to special-handling procedures.
    • Document audit findings in the Compliance Audit Log (Annexure-7).

6. Abbreviations

7. Documents

  1. Material Handling Log (Annexure-1)
  2. Environmental Monitoring Log (Annexure-2)
  3. Special-Handling Material Inspection Log (Annexure-3)
  4. Special-Handling Deviation Report (Annexure-4)
  5. Corrective Action Log (Annexure-5)
  6. Training Log (Annexure-6)
  7. Compliance Audit Log (Annexure-7)

8. References

9. SOP Version

Version: 2.0

See also  SOP for Reporting Deviations in Quarantined Raw Materials - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Handling Log

Date Material Name Batch Number Handling Procedure Handled By
01/02/2025 Hazardous Chemical X HX-2025-001 Transferred to Flammable Storage Cabinet Ravi Kumar

Annexure-2: Environmental Monitoring Log

Date Storage Area Temperature (°C) Humidity (%) Checked By
01/02/2025 Cold Room A 4°C 45% Sunita Sharma

Annexure-3: Special-Handling Material Inspection Log

Date Material Name Batch Number Inspection Findings Inspected By
02/02/2025 Biological Agent Y BY-2025-002 No Contamination Detected Anjali Mehta

Annexure-4: Special-Handling Deviation Report

Date Material Name Batch Number Deviation Description Reported By
03/02/2025 Hazardous Chemical X HX-2025-001 Temperature Excursion (+3°C) Ajay Singh

Annexure-5: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
04/02/2025 Temperature Excursion Calibrated Temperature Sensor Ravi Kumar Anjali Mehta

Annexure-6: Training Log

Date Training Topic Trainer Attendee Name Signature
05/02/2025 Special-Handling Procedures Health & Safety Officer Sunita Sharma

Annexure-7: Compliance Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
06/02/2025 Special-Handling Compliance Labeling Incomplete Updated Labeling Procedure Anjali Mehta

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 Procedures for Special-Handling Materials Regulatory Compliance QA Head
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