to all weighing activities for raw materials performed in the designated dispensing and weighing areas of the Gel Manufacturing department.

3. Responsibilities

• Dispensing Operator: Performs the weighing operation as per the Batch Manufacturing Record (BMR).
• QA Officer: Verifies weighing operations and ensures GMP compliance.
• Supervisor: Monitors weighing activity and signs off on records.

4. Accountability

The Head of Manufacturing is accountable for ensuring the accuracy and traceability of the weighing process in gel formulation.

5. Procedure

5.1 Preparation for Weighing

1. Verify that the weighing area has been cleared by QA and is marked as “Ready for Use”.
2. Ensure all balances are calibrated and verified before use. Record balance ID and calibration status in the logbook.
3. Wear appropriate PPE: gown, mask, gloves, and head cap.

5.2 Verification of Raw Materials

1. Check raw material name, item code, lot/batch number, and expiry date against the requisition slip.
2. Confirm the QC release status and ensure the container is intact with appropriate labeling.

5.3 Weighing Operation

1. Use clean, labeled containers for each material being weighed.
2. Place the container on the balance and tare it before adding the material.
3. Weigh the exact quantity as specified in the BMR, allowing a ±2% tolerance where applicable.
4. Record actual weight, operator initials, and time of weighing in the Weighing Log (Annexure-1).
5. Immediately cover the container to avoid contamination and label it appropriately.

5.4 Handling of Sensitive Materials

1. For hygroscopic materials, perform weighing in controlled humidity areas or use desiccators.
2. Light-sensitive materials should be handled under yellow light and stored in amber containers.

5.5 Labeling and Reconciliation

1. Affix a weighing label with material name, code, batch number, quantity, date, and initials.
2. Submit the weighed materials for verification and release by QA using the Weighing Approval Form (Annexure-2).
3. Ensure reconciliation of material used, weighed, and balance returned to stores.

5.6 Documentation and Review

1. Attach the label copy and weighing data to the BMR.
2. Ensure all entries are made with indelible ink, dated, and signed.
3. Incorrect entries must be struck-through with a single line and justified with remarks and signature.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Weighing Log – Annexure-1
2. Weighing Approval Form – Annexure-2

8. References

• WHO GMP Guidelines
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Schedule M – Drugs and Cosmetics Rules (India)

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: Weighing Log

Date	Material	Batch No.	Target Qty	Actual Qty	Balance ID	Operator
02/06/2025	Methyl Paraben	MPB2401	5.00 kg	5.02 kg	BLN-03	Rajesh Kumar

Annexure-2: Weighing Approval Form

Material	Methyl Paraben
Batch No.	MPB2401
Weighed By	Rajesh Kumar
Verified By	QA Officer
Approval Date	02/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
02/06/2025	2.0	Updated for compliance, added verification steps and annexures	Annual Review	QA Head