SOP for Validating Weighing Balances in Aerosol Manufacturing

Department	Aerosol
SOP No.	SOP/Aerosol/134/2025
Supersedes	SOP/Aerosol/134/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the validation of weighing balances used in aerosol manufacturing. The SOP ensures that the weighing balances used for measuring raw materials, formulations, and other ingredients meet the required accuracy, reliability, and performance standards. Validation is crucial for ensuring that the weighing equipment performs consistently and accurately throughout the manufacturing process.

2. Scope

This SOP applies to all weighing balances used in aerosol manufacturing operations. It covers the procedures for validating the performance and accuracy of these balances, including calibration, testing, and documentation of results. The validation process should be performed whenever a new balance is installed, following significant maintenance or calibration, or as part of routine quality control checks.

3. Responsibilities

• Engineering Team: Responsible for overseeing the calibration and validation process for weighing balances, ensuring that they meet the required specifications.
• Production Team: Responsible for assisting with the validation process by using the weighing balances according to standard operating procedures and documenting any necessary details during routine usage.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the validation documentation and ensuring that the process complies with Good Manufacturing Practices (GMP) and regulatory standards.
• Maintenance Team: Responsible for maintaining the weighing balances and performing corrective actions if any issues are detected during the validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all weighing balances are validated before use and periodically throughout their operational life. The QA Manager is responsible for overseeing the compliance of this SOP and ensuring that validation results are properly documented and reviewed.

5. Procedure

5.1. Preparing for Weighing Balance Validation

1. Ensure that the weighing balance is clean and in proper working condition before starting the validation process.
2. Verify that all necessary materials and tools are available for validation, including calibrated test weights, documentation forms, and validation protocol.
3. Check the manufacturer’s manual for specific requirements related to the installation, calibration, and validation procedures for the balance.
4. Confirm that the weighing balance is installed on a stable surface and that it is leveled properly.
5. Ensure that the balance is connected to the necessary utilities (e.g., power supply, network) and that it is operational.

5.2. Validating the Weighing Balance

1. Follow the specific calibration procedure as outlined in the balance’s user manual or the standard operating procedure for calibration. Ensure that the calibration is performed at multiple points across the specified range of the balance.
2. Perform the following tests as part of the validation process:
   • Zero Balance Test: Verify that the balance reads zero when no weight is placed on it.
   • Repeatability Test: Weigh a standard test weight multiple times (at least 10) to ensure that the balance provides consistent readings. The deviation between measurements should be within the allowable limits specified in the balance’s technical specifications.
   • Linearity Test: Weigh a series of standard test weights across the full range of the balance to check that the readings are consistent and linear. Any deviations should be noted and corrected.
   • Accuracy Test: Use known test weights to confirm that the balance provides accurate readings. Compare the balance’s readings with the known weight values. The deviation should be within the acceptable tolerance limits specified by the manufacturer.
   • Environmental Testing: Verify that the balance operates correctly under the environmental conditions in which it will be used (e.g., temperature, humidity). Ensure that the balance is not affected by environmental factors outside the specified operating range.
3. Record all test results, including the values measured during each test and any deviations observed. Document the actions taken to resolve any issues, including recalibration or maintenance performed.

5.3. Documenting the Validation Results

1. Document the results of the weighing balance validation in the Validation Report (Annexure-1). The report should include:
   • Equipment ID, model, serial number, and location of the balance
   • Details of the calibration and testing performed (e.g., zero test, repeatability, accuracy, linearity, environmental testing)
   • The results of each test, including any deviations or non-conformities
   • The corrective actions taken if any issues were observed during validation
   • The name and signature of the personnel who performed the validation and reviewed the results
2. Ensure that the validation report is signed and approved by the Engineering team, Production team, and QA team.

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Validation Report to ensure that all tests have been conducted according to the established protocol and that the weighing balance meets the required accuracy and performance specifications.
2. If any deviations are observed during validation, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be implemented, and the validation process should be repeated if necessary.
3. The QA team should approve the report once all validation activities are complete, and any corrective actions have been implemented.

5.5. Finalizing the Validation Process

1. Once the validation is approved, the weighing balance is considered validated and can be used for regular production operations.
2. All documentation, including the Validation Report and any supporting documents (e.g., deviation reports, corrective actions), should be archived and easily accessible for future audits or reviews.
3. Schedule periodic revalidation and calibration activities as per the manufacturer’s recommendations and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

7. Documents

1. Weighing Balance Validation Report (Annexure-1)
2. Deviation Log (Annexure-2)

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
• International Council for Harmonisation (ICH) Guidelines

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 Balance Validation Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
WB-001	Model X	SN123456	06/02/2025	Zero Test	Pass
WB-001	Model X	SN123456	06/02/2025	Repeatability Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Repeatability test failed	Recalibrated balance	Rajesh Patel	Completed

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 validation testing procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures