The QA Manager is responsible for verifying material integrity post-emergency and ensuring regulatory compliance.

5. Procedure

5.1 Identification of Storage Failures

1. Types of Failures:
   • Power outages affecting refrigeration or environmental controls.
   • Equipment malfunctions (e.g., HVAC, cold storage units).
   • Temperature excursions outside of specified ranges.
   • Structural failures (e.g., leaks, flooding, fire).
2. Immediate Identification:
   • Warehouse personnel must regularly monitor environmental controls and report any deviations immediately.
   • Document all identified failures in the Storage Failure Identification Log (Annexure-1).

5.2 Initial Response to Storage Failures

1. Immediate Actions:
   • Isolate the affected area to prevent contamination or further damage.
   • Inform the Warehouse Manager and Safety Officer immediately.
   • Initiate emergency backup systems if applicable (e.g., generators for cold storage).
2. Safety Precautions:
   • Ensure that all personnel are equipped with appropriate Personal Protective Equipment (PPE) when dealing with hazardous materials.
   • Evacuate the area if structural integrity is compromised (e.g., fire, flooding).
   • Document initial response actions in the Emergency Response Log (Annexure-2).

5.3 Material Assessment Post-Failure

1. Quality Assessment:
   • QA personnel must assess the condition of raw materials affected by the storage failure.
   • Conduct visual inspections and, if necessary, laboratory testing to determine material integrity.
   • Document assessment results in the Material Assessment Log (Annexure-3).
2. Decision Making:
   • Based on the assessment, classify materials as Approved, Quarantined, or Rejected.
   • Quarantined materials must be clearly labeled and stored separately until further analysis.
   • Document decisions in the Material Disposition Log (Annexure-4).

5.4 Corrective Actions and Reporting

1. Corrective Actions:
   • Identify root causes of the storage failure and implement corrective measures to prevent recurrence.
   • Repair or replace malfunctioning equipment as required.
   • Document corrective actions in the Corrective Action Log (Annexure-5).
2. Incident Reporting:
   • Prepare a detailed incident report summarizing the failure, actions taken, and outcomes.
   • Submit the report to the QA Manager and Regulatory Affairs, if applicable.
   • Document reports in the Incident Report Log (Annexure-6).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

1. Storage Failure Identification Log (Annexure-1)
2. Emergency Response Log (Annexure-2)
3. Material Assessment Log (Annexure-3)
4. Material Disposition Log (Annexure-4)
5. Corrective Action Log (Annexure-5)
6. Incident Report Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Emergency Action Plans (29 CFR 1910.38)
• WHO GMP Guidelines for Storage and Distribution of Pharmaceuticals

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 Failure Identification Log

Date	Failure Type	Area Affected	Description	Identified By
13/03/2025	Power Outage	Cold Storage Unit 1	Refrigeration failure for 2 hours	Ravi Kumar
13/03/2025	HVAC Malfunction	Storage Room B2	Temperature exceeded 25°C	Neha Verma

Annexure-2: Emergency Response Log

Date	Failure Type	Immediate Actions Taken	Responsible Person	Outcome
13/03/2025	Power Outage	Activated backup generator for cold storage	Ravi Kumar	Power restored, temperature maintained
13/03/2025	HVAC Malfunction	Transferred temperature-sensitive materials to alternative storage	Neha Verma	Materials secured, HVAC repairs initiated

Annexure-3: Material Assessment Log

Date	Material Name	Batch Number	Assessment Method	Result (Pass/Fail)	Assessed By
13/03/2025	Vitamin C	VC-7890	Visual Inspection & Stability Test	Pass	Priya Singh
13/03/2025	Insulin	INS-4567	Potency Test	Fail	Amit Joshi

Annexure-4: Material Disposition Log

Date	Material Name	Batch Number	Disposition Status (Approved/Quarantined/Rejected)	Remarks	Verified By
13/03/2025	Vitamin C	VC-7890	Approved	No quality deviation found	Ravi Kumar
13/03/2025	Insulin	INS-4567	Rejected	Potency loss due to temperature excursion	Neha Verma

Annexure-5: Corrective Action Log

Date	Failure Type	Root Cause	Corrective Action Implemented	Responsible Person
13/03/2025	Power Outage	Generator switch failure	Repaired switch, installed automatic failover system	Ravi Kumar
13/03/2025	HVAC Malfunction	Blocked air filters	Replaced filters, scheduled monthly maintenance checks	Neha Verma

Annexure-6: Incident Report Log

Date	Incident Description	Area Affected	Immediate Response	Final Resolution	Reported By
13/03/2025	Cold storage failure due to power outage	Cold Storage Unit 1	Activated backup generator	Power restored, materials re-assessed	Ravi Kumar
13/03/2025	Temperature excursion in general storage	Storage Room B2	Transferred materials to alternative storage	HVAC repaired, affected materials evaluated	Neha Verma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
13/03/2025	2.0	Updated emergency protocols and assessment procedures	Alignment with revised GMP and safety guidelines	QA Head