Standard Operating Procedure for Cross-Checking Weighed Materials Before Issuance

Department	Warehouse / Production / Quality Assurance
SOP No.	SOP/RM/199/2025
Supersedes	SOP/RM/199/2022
Page No.	Page 1 of 15
Issue Date	04/05/2025
Effective Date	11/05/2025
Review Date	04/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cross-checking weighed raw materials before issuance to ensure accuracy, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the weighing, verification, and issuance of raw materials for pharmaceutical manufacturing.

3. Responsibilities

• Warehouse Staff: Weigh raw materials accurately and ensure proper documentation.
• Production Supervisor: Cross-check and verify the weighed materials before usage in production.
• Quality Assurance (QA) Team: Oversee compliance with weighing protocols and conduct periodic audits.

4. Accountability

The Warehouse Manager is accountable for ensuring accurate weighing and cross-checking of materials before issuance. The Production Supervisor is responsible for verifying the correctness of materials used in manufacturing, while the QA Manager ensures compliance through audits.

5. Procedure

5.1 Preparation for Material Weighing

1. Review of Batch Manufacturing Record (BMR):
   • The Warehouse Supervisor reviews the BMR to identify the required materials and quantities.
   • Document the review in the BMR Review Log (Annexure-1).
2. Calibration of Weighing Equipment:
   • Ensure that all weighing equipment is calibrated before use.
   • Record calibration details in the Equipment Calibration Log (Annexure-2).

5.2 Material Weighing Process

1. Weighing of Materials:
   • Weigh the materials according to the specified quantity in the BMR using calibrated equipment.
   • Document the weighed quantities in the Material Weighing Log (Annexure-3).
2. Labeling of Weighed Materials:
   • Label each weighed container with the material name, batch number, and weight.
   • Record labeling details in the Material Labeling Log (Annexure-4).

5.3 Cross-Checking of Weighed Materials

1. Verification of Weighed Materials:
   • The Production Supervisor or QA personnel cross-check the weighed materials against the BMR for accuracy.
   • Document the verification in the Material Verification Log (Annexure-5).
2. Documentation of Discrepancies:
   • Any discrepancies between the weighed materials and the BMR should be reported to QA immediately.
   • Document discrepancies in the Discrepancy Log (Annexure-6).

5.4 Issuance of Verified Materials

1. Approval for Issuance:
   • Only materials that have been cross-checked and verified should be issued to the production department.
   • Document the issuance in the Material Issuance Log (Annexure-7).
2. Handling of Non-Compliant Materials:
   • Non-compliant materials should be quarantined and corrective actions should be initiated.
   • Document corrective actions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

1. Training on Weighing and Cross-Checking Procedures:
   • Conduct regular training sessions for warehouse and production staff on weighing and cross-checking procedures.
   • Document training sessions in the Training Log (Annexure-9).
2. Compliance Audits:
   • QA personnel conduct periodic audits to ensure compliance with weighing and cross-checking procedures.
   • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. BMR Review Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Material Weighing Log (Annexure-3)
4. Material Labeling Log (Annexure-4)
5. Material Verification Log (Annexure-5)
6. Discrepancy Log (Annexure-6)
7. Material Issuance Log (Annexure-7)
8. Corrective Action Log (Annexure-8)
9. Training Log (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on GMP for Pharmaceutical Products
• FDA Guidance on Weighing and Verification Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Review Log

Date	BMR Number	Reviewed By	Remarks
04/05/2025	BMR-12345	Ravi Kumar	Reviewed and Approved

Annexure-2: Equipment Calibration Log

Date	Equipment ID	Calibration Status	Calibrated By
04/05/2025	WEIGH-001	Calibrated	Neha Verma

Annexure-3: Material Weighing Log

Date	Material Name	Batch Number	Weighed Quantity (kg)	Weighed By
04/05/2025	Ibuprofen API	BN-67890	25 kg	Kiran Patel

Annexure-4: Material Labeling Log

Date	Material Name	Label Information	Labeled By
04/05/2025	Ibuprofen API	Batch BN-67890, 25 kg	Amit Joshi

Annexure-5: Material Verification Log

Date	Material Name	Batch Number	Verified By
04/05/2025	Ibuprofen API	BN-67890	QA Team

Annexure-6: Discrepancy Log

Date	Discrepancy Identified	Description	Reported By
04/05/2025	Weight Mismatch	Weighed quantity did not match BMR	QA Team

Annexure-7: Material Issuance Log

Date	Material Name	Batch Number	Issued To
04/05/2025	Ibuprofen API	BN-67890	Production Department

Annexure-8: Corrective Action Log

Date	Issue	Corrective Action Taken	Performed By
04/05/2025	Weight Mismatch	Reweighed and corrected the quantity	Warehouse Staff

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
04/05/2025	Neha Verma	Weighing and Cross-Checking Procedures	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
04/05/2025	2.0	Added procedures for cross-checking weighed materials.	Regulatory Update	QA Head