Standard Operating Procedure for Receiving Organic Solvents and Other Volatile Raw Materials

Department	Warehouse / Quality Assurance / Quality Control / Procurement
SOP No.	SOP/RM/057/2025
Supersedes	SOP/RM/057/2022
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) defines the procedure for the safe and compliant receipt of organic solvents and other volatile raw materials. It ensures proper handling, inspection, documentation, and storage in compliance with Good Manufacturing Practices (GMP) and safety regulations.

2. Scope

This SOP applies to all organic solvents and volatile raw materials received at the facility, including but not limited to acetone, ethanol, methanol, and other flammable or hazardous chemicals. It covers receipt, inspection, storage, and documentation procedures.

3. Responsibilities

• Warehouse Personnel: Inspect and verify solvent containers, handle according to safety procedures, and document receipt details.
• Quality Assurance (QA): Review inspection reports and approve or reject materials based on safety and compliance criteria.
• Quality Control (QC): Conduct additional testing if contamination or safety concerns are detected.
• Procurement Department: Ensure suppliers comply with transportation and safety regulations, and resolve discrepancies.

4. Accountability

The Warehouse Manager is responsible for ensuring safe receipt and handling of solvents and volatile materials. The QA Manager holds authority to approve or reject materials based on inspection outcomes, while the Procurement Manager ensures supplier compliance with regulatory requirements. The QC Manager oversees testing if contamination is suspected.

5. Procedure

5.1 Pre-Receipt Preparations

1. Supplier Requirements:
   • Procurement ensures suppliers provide Material Safety Data Sheets (MSDS), Certificates of Analysis (CoA), and proper labeling.
   • Confirm that transportation complies with hazardous materials regulations, including the use of flameproof vehicles if required.
2. Warehouse Preparations:
   • Designate a specific unloading area for volatile materials, equipped with ventilation and fire safety measures.
   • Ensure that spill control materials and personal protective equipment (PPE) are available.

5.2 Receipt and Inspection of Solvents

1. Initial Visual Inspection:
   • Inspect containers for:
     • Signs of leakage, corrosion, or damage.
     • Proper labeling, including hazard symbols, batch numbers, and expiration dates.
     • Integrity of seals and closures.
   • Document findings in the Solvent Receipt Log (Annexure-1).
2. Documentation Verification:
   • Verify accompanying documents (MSDS, CoA, transport documentation) against purchase orders and specifications.
   • Record verification results in the Documentation Compliance Log (Annexure-2).

5.3 Safe Handling and Storage

1. Unloading Procedures:
   • Use forklifts or drum handlers designed for flammable materials.
   • Avoid any sparks, open flames, or heat sources in the unloading area.
2. Storage Requirements:
   • Store solvents in flameproof storage cabinets or designated solvent storage rooms.
   • Ensure appropriate ventilation and maintain temperature controls as per MSDS recommendations.
   • Label storage areas clearly with hazard signs.
   • Document storage conditions in the Solvent Storage Log (Annexure-3).

5.4 Handling Discrepancies or Safety Concerns

1. Identification of Issues:
   • If leaks, contamination, or labeling discrepancies are detected, segregate the material immediately.
   • Label as “UNDER REVIEW” and report to QA for further evaluation.
   • Document discrepancies in the Solvent Discrepancy Report (Annexure-4).
2. Corrective Actions:
   • QA assesses safety and compliance risks and instructs further actions (e.g., QC testing, return to supplier).
   • Procurement contacts the supplier for corrective measures, including replacement or improved packaging.
   • Document all corrective actions in the Corrective Action Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• MSDS: Material Safety Data Sheet
• CoA: Certificate of Analysis
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Solvent Receipt Log (Annexure-1)
2. Documentation Compliance Log (Annexure-2)
3. Solvent Storage Log (Annexure-3)
4. Solvent Discrepancy Report (Annexure-4)
5. Corrective Action Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• OSHA Hazard Communication Standard
• 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: Solvent Receipt Log

Date	Solvent Name	Batch Number	Packaging Condition	Labeling Correct	Received By	Remarks
01/02/2025	Acetone	A-2025-001	Intact	Yes	John Doe	Compliant
01/02/2025	Ethanol	E-2025-002	Minor Leakage	No	Jane Smith	Segregated for QA Review

Annexure-2: Documentation Compliance Log

Date	Solvent Name	Batch Number	MSDS Provided	CoA Provided	PO Compliance	Verified By	Remarks
01/02/2025	Acetone	A-2025-001	Yes	Yes	Yes	John Doe	All Documents Verified

Annexure-3: Solvent Storage Log

Date	Solvent Name	Batch Number	Storage Location	Temperature (°C)	Inspected By	Remarks
01/02/2025	Acetone	A-2025-001	Flameproof Cabinet	25°C	John Doe	Compliant

Annexure-4: Solvent Discrepancy Report

Date	Solvent Name	Batch Number	Discrepancy Description	Reported By	Corrective Action	Status
01/02/2025	Ethanol	E-2025-002	Minor Leakage	Jane Smith	Supplier Contacted, Replacement Requested	Under Review

Annexure-5: Corrective Action Log

Date	Supplier Name	Solvent Name	Batch Number	Corrective Action Taken	Follow-Up Required
02/02/2025	PharmaChem Ltd.	Ethanol	E-2025-002	Replaced Damaged Batch	Yes

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 Handling and Safety Protocols	Regulatory Compliance	QA Head