SOP for Weighing and Dispensing Raw Materials
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/002/2025 |
| Supersedes | SOP/Aerosol/002/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures for the accurate weighing and dispensing of raw materials used in the manufacture of aerosol dosage forms. It ensures that the correct quantities of raw materials are dispensed in compliance with Good Manufacturing Practices (GMP) and are suitable for use in production.
2. Scope
This procedure applies to all personnel involved in the weighing and dispensing of raw materials for aerosol dosage forms at [Company Name]. It covers the steps to be followed for accurate weighing, dispensing, and verification of materials before use in the manufacturing process. This SOP does not apply to the handling or processing of finished products.
3. Responsibilities
- Weighing Personnel: Responsible for accurately weighing raw materials in accordance with the specifications and ensuring that all materials are dispensed in the correct quantities.
- Quality Control (QC) Team: Responsible for verifying the quantities of dispensed raw materials and conducting any necessary testing on the materials as per specifications.
- Warehouse Supervisor: Ensures that the raw materials are properly stored before weighing and dispensed in an organized manner.
- Production Personnel: Responsible for
ensuring that the dispensed raw materials are properly handled and used in the production process.
4. Accountability
The Production Manager is accountable for ensuring that this SOP is followed during the weighing and dispensing of 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. Weighing of Raw Materials
- Before weighing, ensure that the weighing balance is calibrated and free from any contamination. The balance should be cleaned as necessary before use.
- Place the appropriate container on the weighing balance, tare it to zero, and then weigh the raw material according to the required specifications for the batch.
- Ensure that the correct quantity is dispensed as per the batch requirement. If the material is dispensed in excess, return the excess to the appropriate storage container.
- Record the weight of the material in the Weighing Log, noting the material name, batch number, and date.
- If the material does not meet the weight requirements, it must be rejected and reported to the Warehouse Supervisor for investigation.
5.2. Dispensing of Raw Materials
- Ensure that the raw material to be dispensed is from an approved batch and that it has passed any required quality control checks.
- Dispense the raw material into the designated dispensing containers. The correct labeling should be ensured for each container, including batch number and material name.
- Seal and label the containers properly once the dispensing is complete to ensure that they are identified correctly during the next stages of production.
- Document the dispensing activity in the Dispensing Log, including the material name, batch number, quantity dispensed, and the operator’s name.
5.3. Testing and Verification
- The QC team will verify the dispensed quantities using appropriate verification methods. Any discrepancies should be noted and rectified immediately.
- If any raw material fails the verification test or has a discrepancy in weight, it must be placed in quarantine, and the issue should be investigated immediately.
5.4. Corrective and Preventive Actions (CAPA)
- In case of a discrepancy in the dispensed quantities or any failures in the weighing process, corrective actions must be initiated. This may involve recalibrating the weighing balance or retraining personnel on weighing procedures.
- Preventive actions should be implemented to prevent future occurrences. This may include improving material handling practices or establishing additional checks for weighing and dispensing activities.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CAPA: Corrective and Preventive Actions
7. Documents
- Weighing Log (Annexure-1)
- Dispensing Log (Annexure-2)
- Dispensing Discrepancy Report (Annexure-3)
- Weighing Balance Calibration Log (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 Log
| Material Name | Batch No. | Weight | Weighing Date | Operator |
|---|---|---|---|---|
| Example Material | 12345 | 100 kg | 06/02/2025 | Ravi Kumar |
Annexure-2: Dispensing Log
| Material Name | Batch No. | Quantity Dispensed | Dispensing Date | Operator |
|---|---|---|---|---|
| Example Material | 12345 | 50 kg | 06/02/2025 | Rajesh Patel |
Annexure-3: Dispensing Discrepancy Report
| Discrepancy Description | Action Taken | Responsible Party | Resolution Date |
|---|---|---|---|
| Over-dispensed material | Returned excess to storage | Ravi Kumar | 07/02/2025 |
Annexure-4: Weighing Balance Calibration Log
| Balance ID | Calibration Date | Calibration Result | Next Calibration Due |
|---|---|---|---|
| WB-001 | 01/01/2025 | Pass | 01/07/2025 |
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 weighing and dispensing procedures | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |