Standard Operating Procedure for Weighing of Raw Materials Under LAF in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/015/2025 |
| Supersedes | SOP/API/015/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the procedure for weighing raw materials under Laminar Air Flow (LAF) to maintain accuracy, prevent cross-contamination, and ensure environmental control in accordance with GMP principles.
2. Scope
This SOP applies to the weighing of all raw materials used in API manufacturing that require controlled environmental conditions to ensure product quality and operator safety.
3. Responsibilities
- Warehouse Operator: Conduct weighing under LAF, maintain cleanliness, and record weights accurately.
- QA Officer: Verify LAF conditions and check for adherence to weighing procedure.
- Engineering Team: Maintain and calibrate LAF units and balances as per schedule.
4. Accountability
The Warehouse Manager is accountable for ensuring that weighing operations under LAF are performed correctly, recorded, and that equipment is validated and maintained.
5. Procedure
5.1 Pre-Weighing Checks
- Ensure the LAF unit is operational and cleaned as per its respective SOP.
- Switch ON the LAF and allow for a minimum of 15 minutes of air flow before initiating weighing.
- Verify that the area is clean and that cleaning status label is in place.
- Check the calibration status of the balance — calibration date must be current.
- Check raw material label for:
- Name
- Batch No.
- Status (Approved)
- Expiry Date
5.2 Weighing Procedure
- Wear appropriate PPE including gloves, mask, and clean room gown.
- Place a clean, pre-labeled container or liner on the balance.
- Tare the balance to zero.
- Using a clean scoop, slowly transfer the required quantity of material to the container.
- Ensure minimal dusting and avoid spilling by transferring at low height.
- Record the net weight and verify it against the material requisition.
- Once complete, close the container securely and affix “WEIGHED” label with:
- Material Name
- Batch No.
- Weighed Quantity
- Weighed By
- Date & Time
5.3 Post-Weighing Activities
- Clean the balance and working surface with 70% IPA.
- Switch OFF the LAF after allowing for a 10-minute post-operation air flush.
- Return the excess material (if applicable) back to the original container and label as “PARTIAL.”
- Log the weighed material in the “Weighing Logbook” (Annexure-1).
- QA to cross-check the label and quantity before transferring material to the production staging area.
6. Abbreviations
- SOP: Standard Operating Procedure
- LAF: Laminar Air Flow
- IPA: Isopropyl Alcohol
- QA: Quality Assurance
7. Documents
- Weighing Logbook (Annexure-1)
- Balance Calibration Record (Annexure-2)
- LAF Cleaning Record (Annexure-3)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- 21 CFR Part 211.68 – Automatic, mechanical, and electronic equipment
- WHO TRS 961 Annex 9 – Guidance on Good Storage Practice
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 Logbook
| Date | Material | Batch No. | Weighed Qty | Weighed By | Verified By |
|---|---|---|---|---|---|
| 13/04/2025 | API-123 | AP202504 | 15 kg |
Annexure-2: Balance Calibration Record
| Date | Balance ID | Calibrated By | Next Due | Status |
|---|---|---|---|---|
| 01/04/2025 | BL-101 | 01/10/2025 | Calibrated |
Annexure-3: LAF Cleaning Record
| Date | LAF ID | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|
| 12/04/2025 | LAF-02 | Cleaned & operational |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | GMP Compliance | QA Head |
| 13/04/2025 | 2.0 | Added Post-Weighing Disinfection Step | Audit Finding | QA Head |