production runs.

Quality Assurance (QA) Team: Responsible for reviewing, approving, and ensuring that the validation protocol complies with GMP standards and regulatory requirements.

Maintenance Team: Responsible for ensuring the proper maintenance and calibration of the mixing tanks, and addressing any issues that arise during the validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the mixing tank validation process is carried out according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Mixing Tank Validation

1. Ensure that the mixing tank is clean and free from any contaminants before starting the validation process.
2. Verify that all necessary equipment for validation, including calibration tools, test products, and monitoring instruments (e.g., thermometers, flow meters), are available and functional.
3. Review the manufacturer’s specifications and technical manuals for the mixing tank to understand the operating parameters that must be validated (e.g., mixing speed, temperature control, pressure limits).
4. Establish the validation team, which should include members from the Engineering, Production, and QA teams.
5. Ensure that the mixing tank is installed properly and is free of any mechanical defects that could affect its performance during validation.

5.2. Conducting the Mixing Tank Validation

1. Perform the following tests as part of the mixing tank validation process:
   • Mixing Speed Test: Verify that the tank’s mixing speed is adjustable and functions within the specified range. Test the speed using a calibrated tachometer or other suitable measurement devices.
   • Mixing Time Test: Verify that the specified mixing time is sufficient for achieving a homogenous mixture. Use sample collection at different time intervals during the mixing process to check for uniformity in the product.
   • Temperature Control Test: Verify that the mixing tank can maintain the required temperature throughout the mixing process. Use calibrated thermometers to check the temperature at multiple points within the tank during mixing.
   • Homogeneity Test: Verify that the formulation is homogeneous by taking samples from different locations in the tank and testing for consistency. The samples should be analyzed for uniformity of active ingredient concentration, viscosity, and other critical parameters.
   • Pressure Test: Verify that the tank can maintain pressure if the process requires it (e.g., in the case of pressurized mixing). Perform leak tests to confirm that the tank does not lose pressure during the mixing process.
2. During testing, record all test results, including the test conditions, measured values, and any deviations observed. Document the results in the Mixing Tank Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the Mixing Tank Validation Report (Annexure-1):
   • Mixing tank ID, model number, serial number, and location
   • The test parameters and conditions, including mixing speed, time, temperature, and pressure
   • The results of each validation test, including any deviations or non-conformities
   • The corrective actions taken to address any issues encountered during testing
   • The name and signature of the personnel performing the tests
   • The approval signatures from the QA team
2. Ensure that the validation report is signed by the responsible personnel and reviewed by the QA team for accuracy and completeness.

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Mixing Tank Validation Report to ensure that all tests were conducted according to the protocol and that the tank meets the required specifications for performance.
2. If any deviations are observed during the validation process, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be implemented, and the tests should be repeated to verify the effectiveness of the corrective actions.
3. The QA team should approve the report once all validation activities are complete and any deviations have been addressed.

5.5. Finalizing the Validation Process

1. Once the mixing tank is validated, it is considered qualified and can be used for regular production activities.
2. All documentation, including the Mixing Tank Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic revalidation and calibration activities should be scheduled 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
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification

7. Documents

1. Mixing Tank 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: Mixing Tank Validation Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
MIX-001	Model A	SN123456	06/02/2025	Mixing Speed Test	Pass
MIX-001	Model A	SN123456	06/02/2025	Homogeneity Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Temperature deviation during mixing	Recalibrated temperature control system	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