Aerosol: SOP for Weighing and Dispensing Raw Materials – V 2.0

Auditor

3 weeks ago

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