Standard Operating Procedure for Secure Storage and Access Control for High-Purity Solvents

Department	Warehouse / Quality Assurance / Safety
SOP No.	SOP/RM/191/2025
Supersedes	SOP/RM/191/2022
Page No.	Page 1 of 15
Issue Date	26/04/2025
Effective Date	03/05/2025
Review Date	26/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the secure storage and controlled access of high-purity solvents to ensure product integrity, safety, and regulatory compliance.

2. Scope

This SOP applies to all personnel involved in the storage, handling, and monitoring of high-purity solvents within the warehouse environment, including temperature-controlled storage zones and restricted access areas.

3. Responsibilities

• Warehouse Manager: Ensure secure storage conditions are maintained and access is controlled as per the SOP.
• Quality Assurance (QA) Team: Conduct periodic audits to verify compliance with storage and access control requirements.
• Safety Officer: Oversee the implementation of safety protocols for handling high-purity solvents.

4. Accountability

The Warehouse Manager is accountable for ensuring that high-purity solvents are stored securely and that access is restricted. The QA Manager is responsible for auditing compliance, while the Safety Officer ensures adherence to safety protocols.

5. Procedure

5.1 Storage Requirements for High-Purity Solvents

1. Designated Storage Areas:
   • Store high-purity solvents in dedicated, well-ventilated, and explosion-proof storage cabinets or rooms.
   • Document storage locations in the Solvent Storage Log (Annexure-1).
2. Environmental Control:
   • Maintain specified temperature and humidity conditions as per solvent requirements.
   • Record environmental monitoring in the Environmental Monitoring Log (Annexure-2).

5.2 Access Control Measures

1. Restricted Access Protocol:
   • Limit access to authorized personnel only, using key cards or biometric systems.
   • Document access permissions in the Access Authorization Log (Annexure-3).
2. Access Log Maintenance:
   • Maintain an entry and exit log for all personnel accessing the solvent storage area.
   • Record entries in the Access Control Log (Annexure-4).

5.3 Handling and Transfer of High-Purity Solvents

1. Use of Personal Protective Equipment (PPE):
   • Ensure all personnel handling solvents wear appropriate PPE, including gloves, goggles, and lab coats.
   • Document PPE compliance in the PPE Compliance Log (Annexure-5).
2. Safe Transfer Procedures:
   • Transfer solvents using grounded containers and follow standard safety protocols to prevent spills or contamination.
   • Record transfers in the Solvent Transfer Log (Annexure-6).

5.4 Emergency Response and Spill Management

1. Spill Response Procedures:
   • In the event of a spill, immediately contain the solvent using spill kits and report the incident.
   • Document spills in the Spill Incident Log (Annexure-7).
2. Emergency Equipment:
   • Ensure fire extinguishers, eyewash stations, and emergency showers are accessible in storage areas.
   • Record maintenance of emergency equipment in the Emergency Equipment Maintenance Log (Annexure-8).

5.5 Training and Compliance Audits

1. Personnel Training:
   • Provide training to all authorized personnel on solvent handling, storage protocols, and emergency procedures.
   • Document training sessions in the Training Log (Annexure-9).
2. Compliance Audits:
   • Conduct quarterly audits to ensure adherence to SOP protocols and regulatory requirements.
   • Record audit results in the Compliance Audit Log (Annexure-9).

6. Abbreviations

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

7. Documents

1. Solvent Storage Log (Annexure-1)
2. Environmental Monitoring Log (Annexure-2)
3. Access Authorization Log (Annexure-3)
4. Access Control Log (Annexure-4)
5. PPE Compliance Log (Annexure-5)
6. Solvent Transfer Log (Annexure-6)
7. Spill Incident Log (Annexure-7)
8. Emergency Equipment Maintenance Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Guidelines for Chemical Safety and Solvent Storage
• WHO Good Storage Practices for Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Solvent Storage Log

Date	Solvent Name	Storage Location	Stored By
26/04/2025	Acetonitrile (99.9%)	Explosion-Proof Cabinet A	Ravi Kumar

Annexure-2: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Checked By
26/04/2025	Solvent Room 1	20°C	45%	Neha Verma

Annexure-3: Access Authorization Log

Date	Employee Name	Access Level	Authorized By
26/04/2025	Amit Joshi	Full Access	Warehouse Manager

Annexure-4: Access Control Log

Date	Employee Name	Entry Time	Exit Time
26/04/2025	Ravi Kumar	09:00 AM	09:30 AM

Annexure-5: PPE Compliance Log

Date	Employee Name	PPE Used	Checked By
26/04/2025	Neha Verma	Gloves, Lab Coat, Goggles	Safety Officer

Annexure-6: Solvent Transfer Log

Date	Solvent Name	From	To	Transferred By
26/04/2025	Acetonitrile (99.9%)	Storage Room	QC Lab	Amit Joshi

Annexure-7: Spill Incident Log

Date	Solvent Name	Spill Description	Cleaned By
26/04/2025	Methanol (99.8%)	Minor spill during transfer	Kiran Patel

Annexure-8: Emergency Equipment Maintenance Log

Date	Equipment Name	Maintenance Activity	Performed By
26/04/2025	Eyewash Station	Tested and Cleaned	Safety Team

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
26/04/2025	Ravi Kumar	Safe Handling and Storage of Solvents	QA Manager	Completed Successfully

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
26/04/2025	2.0	Added access control protocols and emergency response procedures.	Regulatory Update	QA Head