specified quantities for production.

4. Accountability

The Production Manager is accountable for ensuring that this SOP is followed during the verification of weighed raw materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Weighing Checks

1. Before weighing raw materials, ensure that the weighing balance is calibrated according to the calibration schedule and is functioning properly. Record calibration details in the Weighing Balance Calibration Log (Annexure-1).
2. Ensure that the correct containers for weighing are available and that they are clean and dry.
3. Verify the material name and batch number before weighing the raw material to ensure that the correct material is being dispensed.

5.2. Weighing and Documentation

1. Weigh the required amount of raw material as per the batch production instructions. Ensure that the material is weighed accurately using the correct weighing balance.
2. Record the weight of the dispensed material in the Weighing Log (Annexure-2), including the material name, batch number, date, weight, and the operator’s name or initials.
3. If the weighed material exceeds the required amount, return the excess to the appropriate storage container and document the adjustment in the log.

5.3. Verification of Weighed Quantities

1. The QC team will verify the weighed quantities by cross-checking the weight recorded in the Weighing Log with the required specifications for the batch.
2. If the verified quantity deviates from the required amount, the QC team must investigate the cause and decide whether the material is acceptable for use in production. If discrepancies are identified, document the findings in the Verification Log (Annexure-3).
3. All verification actions must be documented, including any discrepancies found and corrective actions taken.

5.4. Re-Verification and Adjustments

1. If the QC team identifies that the weighed material is not within the acceptable range, the material must be reweighed to ensure accuracy.
2. If an error is identified in the weighing process (e.g., an incorrect amount), corrective actions must be taken. This may include reweighing or retrieving new materials for weighing.
3. The corrected weight should be documented in the Weighing Log and Verification Log. The cause of the error should be investigated, and corrective and preventive actions should be implemented.

5.5. Corrective and Preventive Actions (CAPA)

1. In the event of discrepancies in the weighed quantities, a root cause analysis should be conducted to determine the cause of the error. This may involve reviewing weighing equipment calibration, training procedures, or weighing practices.
2. Corrective actions should be initiated to address the issue immediately, such as recalibrating the equipment, retraining personnel, or revising procedures.
3. Preventive actions should be implemented to ensure that future discrepancies are minimized, such as more frequent calibration checks or additional quality controls during the weighing process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions

7. Documents

1. Weighing Log (Annexure-2)
2. Verification Log (Annexure-3)
3. Weighing Balance Calibration Log (Annexure-1)
4. Discrepancy Report (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Weighing Balance Calibration Log

Balance ID	Calibration Date	Calibration Result	Next Calibration Due
WB-001	01/01/2025	Pass	01/07/2025

Annexure-2: Weighing Log

Material Name	Batch No.	Weight	Weighing Date	Operator
Example Material	12345	100 kg	06/02/2025	Ravi Kumar

Annexure-3: Verification Log

Material Name	Batch No.	Verification Date	Verified By	Verification Result
Example Material	12345	06/02/2025	Rajesh Patel	Verified

Annexure-4: Discrepancy Report

Discrepancy Description	Action Taken	Responsible Party	Resolution Date
Overweight material	Reweighed and corrected	Ravi Kumar	07/02/2025

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	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated verification procedures and corrective actions	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures