Procedure for Cross-Verification of Dispensed Quantities

Department	Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse
SOP No.	SOP/Ointment/176
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 define a systematic approach for cross-verifying dispensed quantities of raw materials in pharmaceutical manufacturing. Proper verification ensures accuracy, minimizes material discrepancies, and maintains compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.

2. Scope

This SOP applies to all personnel involved in the weighing, verification, and approval of dispensed raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments.

3. Responsibilities

• Dispensing Operator: Ensures correct dispensing and prepares materials for verification.
• QA Officer: Verifies and approves dispensed quantities.
• QC Analyst: Conducts random sampling checks to validate dispensed materials.
• Warehouse Supervisor: Ensures accurate material tracking and documentation.
• Production Supervisor: Oversees the verification process and ensures adherence to procedures.

4. Accountability

The QA Manager is accountable for ensuring that all cross-verification activities comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Preparation for Cross-Verification

• Ensure the **weighing and dispensing area is clean** and free from contaminants.
• Verify that the weighing balance is **calibrated and within its validity period**.
• Ensure that dispensed materials are labeled correctly, including:
• Material Name
• Batch Number
• Weighed Quantity
• Weighing Date
• Operator Name
• Check that the dispensed material is stored in **appropriate containers** to prevent contamination.

5.2 Cross-Verification Process

• QA personnel must verify each dispensed material against the **Batch Manufacturing Record (BMR).**
• Use an **independent weighing balance** to verify the quantity of each dispensed material.
• If a discrepancy is detected:
• Reweigh the material to confirm the deviation.
• Record the deviation in the **Cross-Verification Log (Annexure-1).**
• Notify the Production Supervisor and QA department for corrective action.
• If the verification confirms the correct quantity:
• QA must sign off on the **Cross-Verification Log (Annexure-1).**
• Material is **approved for further processing.**

5.3 Handling Cross-Verification Deviations

• If the dispensed quantity **exceeds or falls below** the required limit:
• Material must be **reweighed in the presence of QA personnel.**
• Document the issue in the **Deviation Report (Annexure-2).**
• Corrective action must be implemented before the material is approved.
• Rejected materials must be:
  • Quarantined and labeled as **”Rejected”.**
  • Disposed of according to waste management SOPs.

5.4 Post-Verification Activities

• Ensure that approved materials are transferred to the appropriate **production or storage areas.**
• Update the **Material Usage Log** to track dispensed and verified quantities.
• Submit completed **cross-verification records** to the QA department for review.

5.5 Periodic Review and Audit

• QA must conduct **weekly random checks** to ensure compliance with cross-verification protocols.
• All records must be **retained for at least five years** for audit purposes.
• Deviations must be reviewed in **monthly QA meetings** to identify trends and corrective actions.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Cross-Verification Log (Annexure-1)
• Deviation Report (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Raw Material Handling
• FDA Guidance on Pharmaceutical Manufacturing

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cross-Verification Log

Date	Material Name	Batch No.	Weighed Quantity	Verified Quantity	Operator	QA Review
02/02/2025	API X	SOP/Ointment/1001	5.0 kg	5.01 kg	John Doe	Approved

Annexure-2: Deviation Report

Date	Material Name	Batch No.	Deviation Type	Root Cause	Corrective Action	QA Approval
02/02/2025	API X	SOP/Ointment/1001	Overweight	Operator Error	Reweighed	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Verification Procedures	Improved Compliance	QA Head