verifying weighed quantities and ensuring compliance with SOP.

Engineering: Responsible for maintaining and calibrating microbalances used for weighing.

4. Accountability

Department Head – Gel Manufacturing and Manager – Quality Assurance are accountable for compliance and implementation of this SOP.

5. Procedure

5.1 Pre-Weighing Preparation

1. Ensure that the microbalance is calibrated and within its valid calibration period.
2. Clean the balance area using lint-free cloth and 70% IPA prior to activity.
3. Check balance leveling and ensure the draft shield is functioning properly.
4. Verify room temperature and humidity are within acceptable limits (as per validation protocol).

5.2 Material Verification and Documentation

1. Receive the dispensing slip approved by QA for the specific batch.
2. Verify API label, batch number, retest date, and quantity required against BMR.
3. Document material issuance in the raw material logbook and balance logbook.

5.3 Weighing Procedure

1. Use pre-cleaned and tared weighing vessels such as watch glasses or plastic scoops with known weights.
2. Weigh API using micro spatula gently to avoid spillage and static disturbances.
3. Target quantity should be weighed within ±2% accuracy; reject and reweigh if out of tolerance.
4. Once weighing is complete, close the sample and tare container to avoid contamination.

5.4 Transfer of Weighed API

1. Transfer the weighed API container to manufacturing area in a closed, double-bagged labeled container.
2. Label should include API name, weight, batch number, date, and analyst signature.
3. Get QA clearance before transferring material for further processing.

5.5 Post-Weighing Cleanup and Documentation

1. Clean the microbalance surface and surroundings after activity.
2. Log the final weighed quantity in the batch record and in the Weighing Logbook.
3. QA to review and sign the weighing activity in the logbook and BMR.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• IPA: Isopropyl Alcohol
• QA: Quality Assurance

7. Documents

1. Micro Weighing Log – Annexure-1
2. Weighing Checklist – Annexure-2
3. Material Transfer Label – Annexure-3

8. References

• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• GMP Guidelines – WHO TRS 986
• Internal Quality and Compliance Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Micro Weighing Log

Date	API Name	Batch No.	Target Quantity	Actual Quantity	Container No.	Analyst Signature

Annexure-2: Weighing Checklist

Checklist Item	Yes/No	Remarks
Microbalance calibrated?
Room condition verified?
Correct API selected?
Container pre-tared?

Annexure-3: Material Transfer Label

API Name
Batch No.
Weighed Quantity
Date of Weighing
Analyst
Container ID
QA Clearance

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
25/05/2022	1.0	Initial release	New SOP	QA Manager
09/06/2025	2.0	Revised procedure and annexures	Compliance update	QA Manager