recorded are accurate, validated, and consistent with GMP requirements, thereby preventing batch failures and deviations.

2. Scope

This SOP applies to all raw materials dispensed for sterile injectable products where weight verification is required prior to batch charging. The process includes independent verification, documentation, and reconciliation of dispensed quantities.

3. Responsibilities

• Stores Chemist: Performs initial weighing and records preliminary weights.
• QA Executive: Independently verifies the weights and signs the verification log.
• Production Pharmacist: Cross-checks dispensed material against the BMR before charging.
• QC Analyst: Verifies weight accuracy where analytical verification is required.

4. Accountability

The Head of QA is accountable for ensuring that no material proceeds to production without verified weights and proper documentation as per this SOP.

5. Procedure

5.1 Preparation and Review

1. Receive MRN and approved BMR from the production department.
2. Ensure all dispensed containers are properly labeled with gross weight, tare weight, and net weight.
3. Check that weighing was performed using calibrated balances.

5.2 Independent Weight Verification

1. QA shall reweigh the container using the same balance or a qualified equivalent in the same area.
2. Verify that the net weight recorded is within the specified tolerance of ±0.1%.
3. Confirm container ID, material name, batch number, and reconcile labels.
4. Sign and date the Weight Verification Log (Annexure-1) immediately after confirmation.

5.3 Recording and Cross-Verification

1. Document the gross weight, tare weight, and net weight as observed by QA.
2. Attach weight verification log to the dispensing record set for QA filing.
3. Production pharmacist shall countersign upon receipt of verified materials.

5.4 Handling Discrepancies

1. If weight difference exceeds ±0.1%, investigate possible root cause (e.g., label error, balance drift).
2. Initiate a deviation report and inform QA Manager for further evaluation.
3. Repeat dispensing and verification if required after corrective action.

5.5 Documentation Requirements

1. Ensure all entries in the weight verification log are legible, traceable, and signed with full name and date.
2. Corrections must follow ALCOA+ principles and be justified in a footnote.
3. Retain all weight verification logs as part of the batch record file.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• MRN: Material Requisition Note
• ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

7. Documents

1. Weight Verification Log – Annexure-1
2. Material Dispensing Record – Annexure-2
3. Deviation Report Form (if applicable) – Annexure-3

8. References

• WHO TRS 986 – Good Manufacturing Practices
• ICH Q9 – Quality Risk Management
• Schedule M – Indian GMP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Store Chemist	QA Executive	Head – Quality Assurance
Department	Warehouse	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Weight Verification Log

Date	Material	Batch No.	Gross (g)	Tare (g)	Net (g)	Verified By
17/06/2025	Mannitol	BN-MAN1025	1025.0	25.0	1000.0	Sunita Reddy

Annexure-2: Material Dispensing Record

Material Name	Batch No.	Qty Required	Qty Dispensed	Dispensed By	Date
Mannitol	BN-MAN1025	1000 g	1000 g	Rajesh Kumar	17/06/2025

Annexure-3: Deviation Report Form

Date	Reference No.	Discrepancy Observed	Root Cause	Corrective Action	Approved By
17/06/2025	DEV-025	Weight mismatch	Labeling Error	Re-weighing and retraining	QA Head

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
20/01/2022	1.0	Initial release	GMP Requirement	QA Head
17/06/2025	2.0	Enhanced ALCOA compliance and annexures	Annual Review	QA Head