SOP for Verification of Raw Materials Before Dispensing – V 2.0

Procedure for Verification of Raw Materials Before Dispensing

Department	Warehouse/Quality Control
SOP No.	SOP/Ointment/003
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to ensure that all raw materials are properly verified before dispensing for ointment manufacturing. This verification process guarantees compliance with Good Manufacturing Practices (GMP) and prevents errors, contamination, or the use of incorrect materials in production.

2. Scope

This SOP applies to all raw materials stored in the warehouse and scheduled for dispensing before ointment production. It includes physical inspection, label verification, batch record confirmation, and documentation review.

3. Responsibilities

Warehouse Personnel: Ensure raw materials are properly labeled and stored.
Quality Control (QC) Personnel: Conduct sampling and verification testing.
Production Supervisor: Approve materials for dispensing after verification.
Quality Assurance (QA) Officer: Ensure compliance with verification standards.

4. Accountability

The Warehouse Manager is accountable for ensuring that all raw materials pass verification before dispensing to the manufacturing area.

5. Procedure

5.1 Raw Material Identification

Ensure all raw materials have clear, legible labeling.
Verify that the material name, batch number, expiry date, and supplier name match the approved specifications.
Check for any damage, leaks, or contamination of packaging.

5.2 Verification of Documentation

Review the Certificate of Analysis (CoA) and ensure it matches the batch number.
Verify that the raw material has undergone QC testing and has an approved status.
Check the Material Safety Data Sheet (MSDS) for handling precautions.
Confirm supplier approval by cross-referencing with the approved vendor list.

5.3 Sampling and Quality Control Check

Ensure that raw material samples were tested as per the defined sampling plan.
Verify the QC test results for physical, chemical, and microbial properties.
Ensure that all test parameters meet the acceptance criteria.
Document the QC verification details in the Raw Material Verification Log.

5.4 Approval for Dispensing

QA personnel will review all verification records before authorizing dispensing.
Materials with discrepancies should be moved to the Quarantine area for further investigation.
Approved materials will be labeled with “Ready for Dispensing” and transferred to the dispensing area.

5.5 Handling of Non-Conforming Materials

Any material failing the verification process should be marked as “Rejected.”
Non-conforming materials should be reported to QA and documented in the Non-Conformance Report (NCR).
Rejected materials must be segregated and disposed of as per company policy.

5.6 Record-Keeping

Maintain verification records for all raw materials.
Ensure all records are signed and dated by the responsible personnel.
Retain records for the required duration as per regulatory guidelines.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
CoA – Certificate of Analysis
MSDS – Material Safety Data Sheet
NCR – Non-Conformance Report

7. Documents

Raw Material Verification Log (Annexure-1)
Non-Conformance Report (Annexure-2)

8. References

WHO GMP Guidelines for Pharmaceutical Manufacturing
ICH Q7: Good Manufacturing Practice Guide
21 CFR Part 211 – Current Good Manufacturing Practices

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Verification Log

Date	Material Name	Batch Number	Verified By	Verification Status	Remarks
01/02/2025	Material A	Batch 12345	John Doe	Approved	Meets specifications
02/02/2025	Material B	Batch 67890	Jane Smith	Rejected	Moisture level exceeded

Annexure-2: Non-Conformance Report (NCR)

Date	Material Name	Batch Number	Issue Identified	Corrective Action	Reviewed By
01/02/2025	Material B	Batch 67890	Microbial contamination	Return to supplier	QA Head
02/02/2025	Material C	Batch 45678	Label mismatch	Re-label	QA Head

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP	QA Head	All	All	Created new SOP
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head	All	All	Revised to meet new documentation standards