with GMP guidelines.

5. Procedure

5.1 Storage Conditions for Liquid Raw Materials

1. Temperature and Humidity Control:
   • Store temperature-sensitive liquids in controlled environments as per the manufacturer’s recommendations.
   • Ensure humidity levels are within acceptable ranges to prevent condensation and contamination.
   • Document temperature and humidity readings in the Liquid Material Environmental Monitoring Log (Annexure-1).
2. Ventilation:
   • Ensure proper ventilation in storage areas to prevent the accumulation of vapors, especially for volatile liquids.
   • Document ventilation checks in the Ventilation Inspection Log (Annexure-2).

5.2 Container and Packaging Requirements

1. Container Integrity:
   • Ensure that all containers are leak-proof, sealed correctly, and made of compatible materials with the stored liquid.
   • Inspect containers regularly for signs of leaks, corrosion, or damage.
   • Document inspections in the Container Integrity Inspection Log (Annexure-3).
2. Secondary Containment:
   • Store liquid raw materials in secondary containment trays to capture leaks or spills.
   • Ensure containment trays are cleaned regularly and inspected for integrity.
   • Record inspections in the Secondary Containment Inspection Log (Annexure-4).

5.3 Labeling and Identification

1. Labeling Requirements:
   • Ensure all containers are labeled with the material name, batch number, expiration date, and storage conditions.
   • For hazardous liquids, include hazard symbols and safety instructions.
   • Document labeling audits in the Labeling Compliance Log (Annexure-5).
2. Color Coding:
   • Use color-coded labels or tags to differentiate between different classes of liquids (e.g., flammable, corrosive, non-hazardous).
   • Update the Color Coding Reference Chart (Annexure-6) as needed.

5.4 Handling and Movement of Liquid Raw Materials

1. Transfer Procedures:
   • Use appropriate pumps and transfer equipment to avoid spills and contamination during material transfer.
   • Ensure personnel are trained in the safe handling of liquid raw materials.
   • Document transfer activities in the Liquid Material Transfer Log (Annexure-7).
2. Spill Response:
   • In case of spills, follow the spill response procedure outlined in the site’s safety manual.
   • Record spill incidents in the Spill Incident Log (Annexure-8).

5.5 Monitoring and Documentation

1. Environmental Monitoring:
   • Monitor and record temperature, humidity, and ventilation readings daily.
   • Review data weekly to ensure compliance with storage conditions.
   • Document monitoring in the Environmental Compliance Review Log (Annexure-9).
2. Deviation Management:
   • Report and investigate any deviations from storage conditions immediately.
   • Document deviations and corrective actions in the Storage Deviation Log (Annexure-10).

6. Abbreviations

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

7. Documents

1. Pressurized Material Environmental Monitoring Log (Annexure-1)
2. Container Integrity Inspection Log (Annexure-2)
3. Pressure Gauge Calibration Log (Annexure-3)
4. Labeling Compliance Log (Annexure-4)
5. Ventilation and Exhaust System Inspection Log (Annexure-5)
6. Emergency Pressure Release Log (Annexure-6)
7. Pressurized Material Handling Training Log (Annexure-7)
8. Incident and Deviation Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• OSHA Regulations for Handling Pressurized Materials
• Material Safety Data Sheets (MSDS) for Specific Pressurized Raw Materials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Pressurized Material Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Pressure (psi)	Humidity (%)	Checked By
04/04/2025	Pressurized Storage Zone A	22°C	120 psi	45%	Ravi Kumar
04/04/2025	Pressurized Storage Zone B	21°C	115 psi	50%	Neha Verma

Annexure-2: Container Integrity Inspection Log

Date	Container ID	Inspection Result	Inspected By
04/04/2025	PR-001	No Leaks, Sealed Properly	Ravi Kumar
04/04/2025	PR-002	Valve Replaced Due to Minor Leak	Neha Verma

Annexure-3: Pressure Gauge Calibration Log

Date	Gauge ID	Calibration Result	Calibrated By
04/04/2025	Gauge-001	Within Limits	Amit Joshi
04/04/2025	Gauge-002	Recalibrated Due to Drift	Priya Singh

Annexure-4: Labeling Compliance Log

Date	Container ID	Label Compliance	Checked By
04/04/2025	PR-001	Compliant	Ravi Kumar
04/04/2025	PR-002	Hazard Symbol Added	Neha Verma

Annexure-5: Ventilation and Exhaust System Inspection Log

Date	System ID	Inspection Result	Inspected By
04/04/2025	Vent-001	Functioning Properly	Amit Joshi
04/04/2025	Exhaust-002	Filter Replaced	Priya Singh

Annexure-6: Emergency Pressure Release Log

Date	Container ID	Reason for Release	Action Taken	Performed By
04/04/2025	PR-002	Overpressure Detected	Pressure Released, Valve Replaced	Ravi Kumar

Annexure-7: Pressurized Material Handling Training Log

Date	Employee Name	Training Topic	Trainer
04/04/2025	Amit Joshi	Safe Handling of Pressurized Containers	QA Manager
04/04/2025	Priya Singh	Emergency Procedures for Pressurized Materials	QA Manager

Annexure-8: Incident and Deviation Log

Date	Incident Description	Root Cause	Corrective Action	Verified By
04/04/2025	Minor Leak Detected in PR-002	Valve Malfunction	Valve Replaced	QA Team

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
04/04/2025	2.0	Updated emergency procedures and added training requirements.	Regulatory Compliance Update	QA Head