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.

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).

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

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

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

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 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