SOP for Validating Temperature Sensors in Aerosol Manufacturing

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the validation of temperature sensors used in aerosol manufacturing. Temperature sensors are critical for monitoring and controlling temperatures during the production process, including the filling, mixing, and curing stages. This SOP ensures that temperature sensors are accurate, reliable, and calibrated according to defined standards, ensuring that product quality and safety are maintained.

2. Scope

This SOP applies to the validation of all temperature sensors used in aerosol manufacturing processes, including those used in mixers, filling machines, storage tanks, and any other temperature-sensitive equipment. The validation process includes the calibration of the temperature sensors, verification of their accuracy, and the documentation of the results.

3. Responsibilities

• Engineering Team: Responsible for overseeing the validation process for temperature sensors, ensuring that the sensors are calibrated and functioning properly according to the defined standards.
• Production Team: Responsible for ensuring the proper operation of the temperature sensors during the manufacturing process and reporting any discrepancies or malfunctions.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the temperature sensor validation documentation, ensuring that the validation meets regulatory standards and GMP requirements.
• Maintenance Team: Responsible for maintaining the temperature sensors and performing corrective actions if any issues are detected during the validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the temperature sensor validation process is conducted and documented in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Temperature Sensor Validation

1. Before starting the validation process, ensure that all temperature sensors are installed correctly and in their designated locations. Verify that the sensors are properly connected to the measurement system and that the system is operational.
2. Ensure that all necessary calibration equipment is available, including calibration thermometers, standard reference materials, and temperature-controlled baths or ovens.
3. Verify that the temperature sensors are clean and free from any contaminants or damage before conducting the validation.
4. Review the manufacturer’s specifications for the temperature sensors to understand the required calibration methods, acceptable tolerance limits, and the performance characteristics of the sensors.
5. Establish the validation team, which should include representatives from the Engineering, Production, and QA teams.

5.2. Conducting the Temperature Sensor Validation

1. Perform the following tests as part of the temperature sensor validation process:
   • Calibration Test: Use a calibrated reference thermometer or temperature calibration device to measure the temperature at several points across the sensor’s operational range. The temperature sensor readings should be compared to the reference thermometer readings to verify accuracy.
   • Accuracy Test: Test the temperature sensor by measuring known temperature standards (e.g., ice water at 0°C and boiling water at 100°C) to ensure that the sensor provides accurate readings under controlled conditions.
   • Repeatability Test: Repeat the calibration test multiple times to ensure that the sensor consistently provides the same readings under the same conditions.
   • Linear Range Test: Verify that the temperature sensor provides consistent and linear readings across its specified temperature range. Use known temperature standards to confirm the sensor’s linearity.
   • Environmental Testing: Verify that the temperature sensor operates correctly under the environmental conditions in which it will be used (e.g., ambient temperature, humidity). Ensure that the sensor’s performance is not affected by factors outside the specified operating range.
2. Record all test results, including the test conditions, measured values, and any deviations observed. Document the calibration, accuracy, and repeatability results in the Temperature Sensor Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the Temperature Sensor Validation Report (Annexure-1):
   • Details of the temperature sensor, including the model, serial number, and installation location
   • The reference calibration standards used for testing
   • The results of each validation test (e.g., calibration, accuracy, repeatability, linear range)
   • The name and signature of the personnel who performed the validation tests
   • The date and time of testing
2. Ensure that the validation report is signed and approved by the responsible personnel (e.g., Engineering, Production, and QA teams).

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Temperature Sensor Validation Report to ensure that all tests have been conducted according to the protocol and that the sensor meets the required accuracy and performance specifications.
2. If any deviations are observed during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken.
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 temperature sensor is validated, it is considered ready for use in the aerosol manufacturing process. The validated sensor can be used for ongoing temperature monitoring and control during production.
2. All documentation, including the Temperature Sensor 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. Temperature Sensor 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

11. Annexures

Annexure-1: Temperature Sensor Validation Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Preparing Equipment Validation Protocols

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for preparing equipment validation protocols for aerosol manufacturing equipment. Equipment validation protocols are essential to verify that the equipment functions as intended and meets the required performance specifications. This SOP ensures that the protocols are created following industry standards, ensuring equipment reliability, quality, and compliance with regulatory requirements.

2. Scope

This SOP applies to the preparation of equipment validation protocols for all aerosol manufacturing equipment, including filling machines, crimping machines, mixers, and other related equipment used in production. It covers the general process for preparing the validation protocol, including outlining the objectives, scope, test methods, acceptance criteria, and personnel responsibilities.

3. Responsibilities

• Engineering Team: Responsible for preparing the equipment validation protocol, ensuring that it includes the correct testing parameters and aligns with equipment specifications.
• Production Team: Responsible for providing input on the practical aspects of equipment operation and assisting with testing during the validation process.
• Quality Assurance (QA) Team: Responsible for reviewing, approving, and ensuring that the equipment validation protocol complies with GMP standards and regulatory requirements.
• Validation Team: Responsible for executing the validation protocol and documenting the results during the equipment validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that equipment validation protocols are prepared and executed as part of the equipment qualification process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing the Equipment Validation Protocol

1. The equipment validation protocol should be prepared for each piece of equipment used in aerosol manufacturing. The protocol should be developed before the equipment is installed or used for production purposes.
2. The validation protocol should include the following sections:
   • Objective: The objective of the validation process, specifying what the validation aims to achieve (e.g., confirming equipment functionality, verifying performance criteria).
   • Scope: A description of the equipment to be validated, including its model, serial number, location, and any relevant operational parameters.
   • Acceptance Criteria: The criteria that must be met for the equipment to be considered validated. These should be based on manufacturer specifications and regulatory requirements, such as filling accuracy, cycle time, crimping consistency, etc.
   • Test Methods: The test methods that will be used to verify the equipment’s performance. These may include functional tests, performance tests, and safety checks.
   • Responsibilities: The roles and responsibilities of the personnel involved in the validation process, including those responsible for performing the tests, reviewing the results, and approving the protocol.
   • Documentation: The documentation requirements for the validation process, including forms, test logs, and any required reports (e.g., Validation Report, Deviation Log).
   • Schedule: The timeline for completing the validation process, including testing and approval stages.
3. The protocol should be tailored to the specific equipment and its intended use in aerosol manufacturing, ensuring that all relevant performance aspects are covered.
4. Ensure that the validation protocol is comprehensive, clear, and free from ambiguities, outlining all necessary steps for successful validation.

5.2. Reviewing the Validation Protocol

1. Once the equipment validation protocol is prepared, it should be reviewed by the Engineering, Production, and QA teams to ensure that it is comprehensive, accurate, and compliant with regulatory standards.
2. The protocol should be checked to ensure that the following points are addressed:
   • All necessary performance parameters and test conditions are specified.
   • The acceptance criteria are achievable and aligned with equipment specifications.
   • The roles and responsibilities of personnel involved in validation are clearly defined.
3. Any discrepancies or missing information should be addressed before the protocol is approved for execution.
4. Once the review is complete, the protocol should be approved by the QA team, and the final version should be signed and dated by the responsible personnel.

5.3. Approving the Validation Protocol

1. After review and revisions, the finalized validation protocol should be approved by the QA team. The approval process ensures that the protocol meets GMP and regulatory requirements and that the tests will be effective in verifying the equipment’s performance.
2. The approved protocol should be stored in a secure location, easily accessible for reference during the validation process and audits.

5.4. Implementing the Validation Protocol

1. Once the protocol is approved, the validation process can begin. The validation team should follow the protocol exactly as outlined, performing all necessary tests and documenting the results.
2. Ensure that all deviations from the protocol are documented in the Deviation Log (Annexure-1), and corrective actions are taken as necessary.
3. After completion of the validation tests, the results should be compiled into a Validation Report (Annexure-2), and any corrective actions taken should be documented and reviewed by the QA team.

5.5. Finalizing and Storing the Validation Protocol

1. Once the validation process is complete and the equipment has been approved for use, the validation protocol and all associated documentation (e.g., test results, deviation logs) should be archived for future reference and audits.
2. All documentation should be maintained in a secure location with controlled access to ensure compliance with GMP guidelines 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

7. Documents

1. Equipment Validation Protocol (Annexure-1)
2. Validation Report (Annexure-2)
3. Deviation Log (Annexure-3)

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

11. Annexures

Annexure-1: Equipment Validation Protocol

Annexure-2: Validation Report

Annexure-3: Deviation Log

12. Revision History:

SOP for Validating Weighing Balances in Aerosol Manufacturing

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

11. Annexures

Annexure-1: Weighing Balance Validation Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Performance Qualification (PQ) of Aerosol Crimping Machines

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for performing Performance Qualification (PQ) of aerosol crimping machines. PQ verifies that the crimping machine consistently performs its intended function under normal operating conditions and meets all performance specifications. The goal is to ensure that the machine is capable of reliably and efficiently producing aerosol products that meet quality standards.

2. Scope

This SOP applies to the Performance Qualification of all aerosol crimping machines used in the manufacturing process. The PQ process covers the verification of machine performance, including crimping consistency, sealing quality, and operational reliability over extended production runs.

3. Responsibilities

• Engineering Team: Responsible for overseeing the Performance Qualification process, performing required tests, and ensuring machine performance meets the specifications.
• Production Team: Responsible for assisting with the setup and operation of the crimping machine during the PQ process and documenting the performance results.
• Quality Assurance (QA) Team: Responsible for reviewing the PQ documentation, approving the PQ report, and ensuring that the machine is qualified for use in production.
• Maintenance Team: Responsible for ensuring that the crimping machine is in optimal condition prior to performing the PQ and addressing any maintenance issues that arise during the process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Performance Qualification of the aerosol crimping machines is carried out in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Performance Qualification

1. Before starting the PQ process, ensure that the aerosol crimping machine has successfully passed the Installation Qualification (IQ) and Operational Qualification (OQ) stages.
2. Ensure that all necessary equipment and materials are available, including aerosol cans, valves, propellants, and sealing materials.
3. Verify that the crimping machine is clean, calibrated, and in good working condition before conducting the PQ process.
4. Ensure that the performance specifications for the crimping machine, as outlined by the manufacturer and internal quality standards, are available for reference during the PQ process.
5. Establish the PQ team, which should include representatives from Engineering, Production, and QA teams.

5.2. Conducting the Performance Qualification

1. Perform the following tests as part of the PQ process:
   • Crimping Consistency: Verify that the crimping machine produces consistent and reliable crimp seals across multiple batches. The test should involve crimping a set number of cans (at least 20) and measuring the consistency of the seal strength and appearance.
   • Sealing Quality: Test the quality of the crimp seal by performing a leak test, ensuring that the crimp is intact and airtight. This test should be performed on several cans, using appropriate methods such as submersion in water or pressure decay tests.
   • Cycle Time: Measure the time required for the crimping machine to complete one cycle, including the time taken to position the aerosol cans, apply the crimp, and remove the finished cans. The cycle time should be within the specified limits for production speed.
   • Machine Performance Under Normal Operating Conditions: Run the crimping machine under normal production conditions for a set period (e.g., 4 hours) to assess the machine’s ability to perform without issues or failures. Monitor for any mechanical failures, downtime, or irregularities in performance.
2. During testing, ensure that all relevant machine settings (e.g., pressure, speed, temperature) are within the specified operating range and meet the manufacturer’s recommendations.
3. Record all test results, including the number of successful crimping cycles, any deviations or failures, and the corrective actions taken. Document the performance data in the Performance Qualification Report (Annexure-1).

5.3. Documenting the Performance Qualification

1. Document the following information in the Performance Qualification Report (Annexure-1):
   • Details of the crimping machine, including the equipment ID, model, serial number, and location
   • The performance specifications for the crimping machine, as well as the operational parameters tested (e.g., crimping consistency, sealing quality, cycle time)
   • The results of each test, including the number of successful tests, any deviations or failures, and the corrective actions taken
   • Signatures of the personnel performing the tests, along with the date and time of testing
2. The Performance Qualification Report should be signed by the responsible team members and reviewed by the QA team.

5.4. Reviewing and Approving the Performance Qualification

1. The QA team should review the Performance Qualification Report to ensure that the crimping machine meets the required performance specifications and is capable of reliably producing quality aerosol products.
2. If any deviations are observed during the PQ process, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be taken, and the tests should be repeated to verify the effectiveness of the corrective actions.
3. The QA team should approve the report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the PQ Process

1. Once the Performance Qualification is completed and approved, the crimping machine can be used for regular production.
2. All documentation, including the Performance Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), should be archived and accessible for future audits and reviews.

6. Abbreviations

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

7. Documents

1. Performance Qualification 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

11. Annexures

Annexure-1: Performance Qualification Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Operational Qualification (OQ) of Filling Machines

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the steps for the Operational Qualification (OQ) of aerosol filling machines. Operational Qualification ensures that the equipment operates within the defined limits and performs as expected during production. This SOP is intended to verify that the filling machines are operating according to the manufacturer’s specifications and are capable of producing products that meet quality and regulatory standards.

2. Scope

This SOP applies to the Operational Qualification of all aerosol filling machines used in the manufacturing process. It covers the testing and verification of operational parameters such as filling accuracy, machine settings, cycle times, and consistency of performance under typical operating conditions.

3. Responsibilities

• Engineering Team: Responsible for conducting the OQ process, ensuring that all tests are performed accurately and according to the specifications outlined in this SOP.
• Production Team: Responsible for supporting the OQ process by providing necessary information about machine settings and assisting in the execution of the qualification tests.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the OQ documentation and ensuring that the tests meet GMP standards and regulatory requirements.
• Maintenance Team: Responsible for ensuring that the filling machines are maintained in optimal condition prior to conducting the OQ process and addressing any maintenance issues that may arise during the qualification process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Operational Qualification of filling machines is conducted and documented according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Operational Qualification

1. Before starting the OQ process, ensure that the filling machines are installed and the equipment is ready for testing, following the Installation Qualification (IQ) protocol.
2. Ensure that all necessary equipment, instruments, and documentation are available, including calibration tools, test weights, and the OQ protocol.
3. Verify that the filling machine is clean and free from contaminants before starting the OQ process.
4. Establish the OQ team, which should include representatives from the Engineering, Production, and QA teams.
5. Review the filling machine’s technical manual and manufacturer specifications to confirm the operational parameters to be tested during the OQ process.

5.2. Conducting the Operational Qualification

1. The following tests should be conducted during the OQ process:
   • Filling Accuracy: Test the accuracy of the filling machine by checking the amount of product dispensed in each cycle using calibrated test containers or weights.
   • Cycle Time: Measure the time it takes to complete a full cycle of the filling machine, ensuring that it meets the specified limits for production speed.
   • Pressure Testing: Test the pressure settings for propellant filling machines to ensure that the pressure is maintained within the required range.
   • Temperature Settings: Verify that the filling machine maintains the specified temperature settings for sensitive products or formulations.
   • Leak Testing: Perform leak tests to ensure that the machine and its components are sealed properly and do not cause any loss of product or propellant during filling.
2. Verify that all machine settings (e.g., volume, speed, pressure, temperature) are within the manufacturer’s specifications and the operational parameters established for production.
3. Each test should be performed three times to ensure consistent performance and accuracy. Record the results in the Operational Qualification Report (Annexure-1).

5.3. Documenting the Operational Qualification

1. Document the following information in the Operational Qualification Report (Annexure-1):
   • The equipment ID, model, and serial number of the filling machine
   • Details of the tests performed, including test conditions, settings, and equipment used
   • Results of the filling accuracy, cycle time, pressure, temperature, and leak tests
   • Any deviations observed during testing, along with corrective actions taken
   • The name of the personnel who performed the qualification tests
   • Approval signatures from the Engineering, Production, and QA teams
2. The Operational Qualification Report should be signed by the responsible team members and reviewed by the QA team.

5.4. Reviewing and Approving the Operational Qualification

1. The QA team should review the Operational Qualification Report to ensure that all tests were performed according to the specifications and that the results meet the required standards for filling machine operation.
2. If any deviations are observed during the OQ 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 tests are complete and any deviations have been addressed.

5.5. Finalizing the OQ Process

1. Once the Operational Qualification is completed and approved, the filling machine can proceed to the Performance Qualification (PQ) phase, or it can be used for production, depending on the next steps defined in the equipment qualification process.
2. All documentation, including the Operational Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), should be archived and accessible for future audits and reviews.

6. Abbreviations

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

7. Documents

1. Operational Qualification 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

11. Annexures

Annexure-1: Operational Qualification Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Installation Qualification (IQ) of Aerosol Manufacturing Equipment

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the Installation Qualification (IQ) process for aerosol manufacturing equipment. Installation Qualification ensures that the equipment is installed according to the manufacturer’s specifications and is capable of operating within the defined limits. This SOP aims to establish the guidelines for verifying the proper installation of equipment before proceeding with further qualification and use in production.

2. Scope

This SOP applies to the installation qualification of all aerosol manufacturing equipment, including filling machines, valves, actuators, mixers, and other related equipment used in the production process. The procedure covers the steps required to verify the proper installation of the equipment, including documentation, inspection, and testing activities.

3. Responsibilities

• Engineering Team: Responsible for overseeing the installation process of the equipment and ensuring that the equipment is installed according to the manufacturer’s specifications.
• Production Team: Responsible for ensuring that the equipment is installed and verified as per the requirements outlined in this SOP.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the Installation Qualification documentation and ensuring that the process complies with GMP standards and regulatory requirements.
• Maintenance Team: Responsible for ensuring that all installation-related maintenance tasks are completed and documented appropriately.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Installation Qualification process is conducted as part of the equipment commissioning process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Installation Qualification

1. Before starting the IQ process, ensure that the equipment is physically installed in the appropriate location as per the manufacturer’s guidelines and the equipment layout plan.
2. Ensure that all necessary documents are available, including the equipment manual, technical specifications, and installation instructions from the manufacturer.
3. Verify that all utilities (e.g., electricity, compressed air, water supply) required for the operation of the equipment are available and connected properly.
4. Establish the Installation Qualification team, which should include representatives from the Engineering, Production, and QA teams.
5. Ensure that any necessary calibration tools, testing devices, and measurement instruments are available for use during the IQ process.

5.2. Conducting the Installation Qualification

1. Verify that the equipment is installed according to the manufacturer’s specifications, including:
   • Correct placement and alignment of all components
   • Secure attachment of all parts
   • Correct connections for power, utilities, and communication interfaces
2. Ensure that all safety features are installed and operational, including emergency stop buttons, safety guards, and interlocks.
3. Verify that all equipment components are labeled properly according to the manufacturer’s instructions.
4. Perform a visual inspection of the equipment to ensure that it is free from physical damage, defects, or missing parts.
5. Ensure that any installation-specific testing (e.g., system functionality tests) is performed, as described in the equipment manual or manufacturer’s guidelines.

5.3. Documenting the Installation Qualification

1. Document the following information in the Installation Qualification Report (Annexure-1):
   • Details of the equipment being qualified (e.g., equipment ID, model, serial number)
   • Location and date of installation
   • Verification of installation steps, including any deviations or non-compliance
   • Results of all tests performed (e.g., functional tests, safety checks)
   • Signatures of the personnel involved in the IQ process
2. Ensure that the IQ report is signed by the Engineering team, the Production team, and the QA team.
3. The completed Installation Qualification Report should be stored as part of the equipment qualification documentation.

5.4. Reviewing and Approving the Installation Qualification

1. The Installation Qualification Report should be reviewed and approved by the QA team to ensure that the equipment meets the specified installation requirements and is ready for the next qualification phase (Operational Qualification or Performance Qualification).
2. If any deviations or non-conformities are identified during the IQ process, they should be documented in the Deviation Log (Annexure-2) and appropriate corrective actions should be taken.
3. The QA team should approve the report once all required steps are complete and any deviations are addressed.

5.5. Finalizing the IQ Process

1. Once the Installation Qualification is complete and approved, the equipment can proceed to the next phase of qualification (Operational Qualification or Performance Qualification).
2. Ensure that all documentation, including the Installation Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), are archived and accessible for future audits and reviews.

6. Abbreviations

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

7. Documents

1. Installation Qualification 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

11. Annexures

Annexure-1: Installation Qualification Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Documenting Cleaning Validation Activities

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for documenting cleaning validation activities for aerosol manufacturing equipment. The purpose of this SOP is to ensure that all cleaning validation activities are properly documented to provide evidence of compliance with Good Manufacturing Practices (GMP) and regulatory requirements. Proper documentation is essential for maintaining the integrity of the cleaning process and for audit readiness.

2. Scope

This SOP applies to the documentation of all cleaning validation activities related to aerosol manufacturing equipment. This includes the cleaning process, validation testing, sample collection, analysis of residues, deviations, corrective actions, and final approval. The SOP also covers the proper handling and storage of documentation related to cleaning validation.

3. Responsibilities

• Production Team: Responsible for executing the cleaning process and ensuring all documentation requirements are met, including logging cleaning activities and maintaining records of cleaning processes.
• Quality Assurance (QA) Team: Responsible for reviewing and approving cleaning validation documentation, ensuring that it meets GMP standards and regulatory requirements.
• Validation Team: Responsible for ensuring that cleaning validation protocols, testing procedures, and sample analysis are documented properly according to this SOP.
• Regulatory Affairs Team: Ensures that the cleaning validation documentation complies with applicable regulatory standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning validation activities are properly documented as part of the cleaning validation process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Documenting the Cleaning Process

1. For each cleaning process, the following details must be documented:
   • Equipment cleaned (e.g., filling machines, valves, pumps)
   • Cleaning procedure used (e.g., manual cleaning, automated cleaning)
   • Date and time of cleaning
   • Name of the operator performing the cleaning
2. The cleaning documentation should be maintained in the Cleaning Log (Annexure-1), and must be signed and dated by the operator and reviewed by the supervisor.
3. The cleaning process documentation should include any deviations from the established cleaning procedure, as well as any corrective actions taken.

5.2. Documenting Cleaning Validation Protocols

1. The cleaning validation protocol should be prepared before the validation activities are carried out. The protocol should include:
   • The cleaning process to be validated
   • Residue limits for active ingredients and cleaning agents
   • The sampling plan and method (e.g., surface swabbing, rinse water testing)
   • Test methods to be used for residue analysis
   • The schedule and personnel responsible for conducting the validation
2. The cleaning validation protocol should be reviewed and approved by the QA team before the validation begins. The protocol approval should be documented in the Cleaning Validation Protocol Approval Log (Annexure-2).

5.3. Documenting Sample Collection and Testing

1. Swab sampling or rinse water sampling should be performed according to the established sampling plan, and the following details must be documented:
   • Sampling location(s)
   • Type of sample collected (swab or rinse water)
   • Method of sample collection
   • Operator performing the sampling
   • Time and date of sampling
2. The sample collection documentation should be recorded in the Sampling Log (Annexure-3).
3. All analytical results should be recorded in the Cleaning Validation Results Report (Annexure-4), including residue levels, microbial contamination, and any deviations or non-conformities.

5.4. Documenting Deviation and Corrective Actions

1. If any deviations occur during the cleaning process or validation, they must be documented in the Deviation Log (Annexure-5). The Deviation Log should include:
   • The description of the deviation
   • The root cause analysis
   • The corrective actions taken
   • The date and time the deviation occurred
   • Names of the personnel involved in resolving the deviation
2. Corrective actions taken to resolve any deviations should be documented and tracked until completion. The corrective actions should also be recorded in the Corrective Action Log (Annexure-6).

5.5. Documenting Final Validation Results

1. Once the cleaning validation activities have been completed, a final Cleaning Validation Report (Annexure-7) should be prepared. The report should include:
   • Summary of the cleaning process and validation activities
   • Results of the residue analysis and microbial testing
   • Any deviations or issues encountered, along with corrective actions taken
   • Conclusion regarding the effectiveness of the cleaning process
2. The Cleaning Validation Report should be reviewed and approved by the QA team. Once approved, the report should be stored in the cleaning validation records.

5.6. Archiving and Retaining Documents

1. All documentation related to cleaning validation activities, including cleaning logs, sampling logs, deviation logs, and validation reports, should be retained for at least 5 years or as per regulatory requirements.
2. Documents should be stored in a secure, easily accessible location for future review and audits. All documents should be organized and cataloged for quick retrieval.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Cleaning Log (Annexure-1)
2. Cleaning Validation Protocol Approval Log (Annexure-2)
3. Sampling Log (Annexure-3)
4. Cleaning Validation Results Report (Annexure-4)
5. Deviation Log (Annexure-5)
6. Corrective Action Log (Annexure-6)
7. Cleaning Validation Report (Annexure-7)

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

11. Annexures

Annexure-1: Cleaning Log

Annexure-2: Cleaning Validation Protocol Approval Log

Annexure-3: Sampling Log

Annexure-4: Cleaning Validation Results Report

Annexure-5: Deviation Log

Annexure-6: Corrective Action Log

Annexure-7: Cleaning Validation Report

12. Revision History:

SOP for Conducting Swab Testing During Cleaning Validation

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for conducting swab testing as part of cleaning validation for aerosol manufacturing equipment. Swab testing is used to verify the removal of residues, including active ingredients, cleaning agents, and contaminants, from the surfaces of equipment after cleaning. The purpose of this SOP is to ensure that swab testing is performed correctly and consistently, and that the equipment meets the established acceptance criteria for cleanliness.

2. Scope

This SOP applies to the use of swab testing as part of cleaning validation for aerosol manufacturing equipment. It covers the swabbing of surfaces that come into direct contact with the product, including filling machines, nozzles, valves, pumps, and containers. This SOP includes the preparation for swab testing, sample collection, analysis of the samples, and documentation of results.

3. Responsibilities

• Production Team: Responsible for conducting the cleaning process and performing swab sampling according to this SOP after the cleaning procedure is complete.
• Quality Assurance (QA) Team: Responsible for overseeing the swab testing process, ensuring compliance with this SOP, reviewing test results, and taking corrective actions if necessary.
• Validation Team: Responsible for ensuring that the swab testing method is validated and that the test results are documented properly in accordance with GMP standards.
• Regulatory Affairs Team: Ensures that swab testing procedures meet regulatory requirements for aerosol manufacturing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that swab testing is conducted as part of the cleaning validation process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Swab Testing

1. Before conducting swab testing, ensure that the cleaning process has been completed and that all equipment surfaces are accessible for testing.
2. Ensure that all necessary materials and equipment for swab testing are available, including sterile swabs, solvent for swabbing (e.g., water or alcohol), sample collection containers, and labeling materials.
3. Prepare the swab testing kit by ensuring that swabs are sterile, and the solvent used for swabbing is compatible with the residue being tested (e.g., cleaning agent or product residues).
4. Verify that appropriate lighting and magnification tools are available to inspect the equipment surfaces during the testing process.
5. Review the cleaning validation protocol to identify the specific surfaces to be swabbed, ensuring that critical areas are included in the swab testing process.

5.2. Selecting Swab Sampling Points

1. Identify the critical surfaces of the equipment that must be swabbed. These include surfaces that directly contact the product and those that are difficult to clean.
2. Common sampling points include:
   • Filling nozzles, pumps, and valves
   • Internal surfaces of containers, tubes, and chambers
   • Surfaces that may retain product residues or cleaning agents after cleaning
3. Ensure that the sampling plan is followed, including the number of swabs per equipment unit and the frequency of swabbing, as outlined in the cleaning validation protocol.

5.3. Performing Swab Sampling

1. Using a sterile swab, moisten the swab with an appropriate solvent (e.g., water or alcohol), ensuring that the swab is adequately wetted but not overly saturated.
2. Swab the identified surfaces in a consistent manner, ensuring that all critical areas are covered. Use a systematic approach to swabbing, including making sure that the swab is applied evenly to the surface.
3. After swabbing, place the swab in a sterile container and seal it to prevent contamination. Label the container with relevant information, including the batch number, sampling point, equipment cleaned, and the date and time of the sampling.
4. Ensure that the swabbed surfaces are inspected for any visible residues before proceeding with the next sampling location.

5.4. Analyzing the Swab Samples

1. Once the swab samples are collected, they should be sent to the laboratory for analysis using validated methods. Common methods for analyzing swab samples include:
   • High-Performance Liquid Chromatography (HPLC): Used to detect and quantify product residues or cleaning agents.
   • Spectrophotometry: Used to detect cleaning agents or other contaminants based on their light absorption properties.
   • Titration: A method for measuring the concentration of cleaning agents or residual active ingredients on swabbed surfaces.
   • pH Measurement: Used to detect residual acidic or alkaline cleaning agents.
2. Once the analysis is complete, compare the results to the established acceptance criteria, including residue limits and microbial contamination levels.
3. If the results show that the residue levels exceed the acceptance criteria, further corrective actions should be taken as described in the Deviation Log (Annexure-2).

5.5. Documenting the Swab Testing Results

1. Document all swab testing activities in the Swab Testing Report (Annexure-1). The report should include:
   • The equipment cleaned and the specific sampling points swabbed
   • The solvent used for swabbing and the amount of solvent applied
   • The results of the swab sample analysis, including residue levels and any deviations from acceptance criteria
   • Any corrective actions taken if residue levels exceed the acceptance criteria
2. Each swab testing report should be signed and dated by the person performing the testing and the person reviewing the results.
3. The Swab Testing Report should be reviewed and approved by the QA team. Once approved, the report should be stored as part of the cleaning validation documentation.

5.6. Corrective Actions for Deviations

1. If the swab testing results show that the equipment does not meet the established cleanliness criteria, corrective actions should be taken. These may include:
   • Re-cleaning the equipment using the appropriate cleaning procedures.
   • Adjusting the cleaning process or agents to achieve better residue removal.
   • Performing additional sampling and testing to verify the effectiveness of the corrective actions.
2. The corrective actions should be documented in the Deviation Log (Annexure-2), including the steps taken to address the deviation and the results of any subsequent testing.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography
• CAPA: Corrective and Preventive Action

7. Documents

1. Swab Testing 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

11. Annexures

Annexure-1: Swab Testing Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Revalidating Cleaning Processes After Modifications

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for revalidating cleaning processes after modifications to aerosol manufacturing equipment, cleaning agents, or procedures. The objective of this SOP is to ensure that any changes made to the equipment or cleaning process do not affect the efficacy of the cleaning process or the quality of the product. Revalidation ensures that the cleaning procedures remain effective and compliant with Good Manufacturing Practices (GMP) and regulatory requirements following modifications.

2. Scope

This SOP applies to the revalidation of cleaning processes for all aerosol manufacturing equipment, including filling machines, valves, pumps, nozzles, and any other components that come into contact with the product. This SOP covers the process of revalidation whenever modifications are made to the equipment, cleaning agents, formulations, or cleaning procedures.

3. Responsibilities

• Validation Team: Responsible for overseeing the revalidation of the cleaning process after any modifications and ensuring the process is executed according to this SOP.
• Production Team: Responsible for carrying out the cleaning process, executing the revalidation process, and providing relevant feedback and documentation.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the revalidation data, ensuring that the revalidation process meets GMP standards and regulatory requirements.
• Regulatory Affairs Team: Ensures that the revalidation process complies with applicable regulatory standards and guidelines.

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning processes are revalidated after modifications are made. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Modifications That Require Revalidation

1. Revalidation should be initiated if any of the following modifications are made:
   • Changes to the cleaning procedure, including new cleaning agents, equipment, or cleaning techniques.
   • Modifications to the aerosol manufacturing equipment, such as new parts, components, or systems that come into direct contact with the product.
   • Changes in the formulation or raw materials that may affect the cleaning process (e.g., new ingredients that leave residues that are harder to clean).
   • Changes in regulatory requirements that impact cleaning standards or validation criteria.
2. Once modifications are identified, the revalidation process should be planned and executed to ensure that the cleaning process remains effective and compliant.

5.2. Reviewing the Modified Cleaning Process

1. Before starting the revalidation, the modified cleaning process should be reviewed to identify any potential impact on the cleaning process:
   • Review the changes made to the equipment or cleaning agents to determine whether they could affect residue levels or the effectiveness of the cleaning process.
   • Identify any new surfaces, materials, or components that may require additional sampling or testing during the revalidation process.
   • Review the acceptance criteria to ensure they remain appropriate for the modified process and equipment.
2. The review should be documented, and any necessary adjustments should be made to the revalidation protocol to address the modifications.

5.3. Preparing the Revalidation Protocol

1. The revalidation protocol should be prepared to include:
   • Objective: The purpose of the revalidation, including the modifications that prompted the revalidation.
   • Scope: The areas affected by the modifications and the cleaning processes that require revalidation.
   • Acceptance Criteria: The residue limits, microbial contamination limits, and any other criteria that need to be met after the cleaning process.
   • Sampling Plan: The sampling locations, methods (e.g., surface swabbing or rinse water sampling), and frequency of sampling required for the revalidation.
   • Test Methods: The analytical methods to be used for testing the residue levels and microbial contamination (e.g., HPLC, spectrophotometry, microbial tests).
   • Schedule: The timeline for conducting the revalidation, including the number of cleaning runs and sample collection dates.
   • Personnel Responsibilities: The roles and responsibilities of the teams involved in the revalidation process.
2. The protocol should be reviewed and approved by the QA team before it is executed.

5.4. Executing the Revalidation

1. Once the revalidation protocol is approved, the revalidation process should be carried out according to the defined procedures. This includes:
   • Cleaning the equipment following the modified cleaning procedure and sampling the cleaned surfaces or rinse water for residue analysis.
   • Performing any microbial tests required to verify that the cleaning process has removed any potential microbial contamination.
   • Analyzing the collected samples using the specified test methods to determine if the cleaning process meets the established acceptance criteria.
2. The revalidation process should include at least three successful cleaning runs to confirm the consistency and effectiveness of the modified cleaning process.

5.5. Reviewing Revalidation Results

1. After the revalidation is complete, the results should be reviewed to ensure that the modified cleaning process meets the acceptance criteria. The review should include:
   • Comparison of the revalidation results with the established acceptance criteria for residue and microbial contamination.
   • Analysis of any deviations or failures in the cleaning process, including corrective actions taken to address the issues.
   • Review of the effectiveness of any corrective actions implemented during the revalidation process.
2. If the revalidation results meet the established criteria, the cleaning process can be considered validated and suitable for use in subsequent production runs.
3. If the results do not meet the criteria, the cleaning procedure should be modified further, and the revalidation process should be repeated until acceptable results are achieved.

5.6. Documenting Revalidation Results

1. All revalidation activities should be documented in the Revalidation Report (Annexure-1). The report should include:
   • The revalidation protocol, including the modifications made to the cleaning process and equipment.
   • The results of the residue and microbial testing, including detailed analysis and any deviations.
   • Any corrective actions taken and their effectiveness in addressing deviations.
   • Approval from the QA team confirming that the revalidation process was successful and the cleaning procedure is effective.
2. The Revalidation Report should be reviewed and approved by the QA team. Once approved, the report should be stored as part of the cleaning validation documentation.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Revalidation 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

11. Annexures

Annexure-1: Revalidation Report

Annexure-2: Deviation Log

12. Revision History:

SOP for Periodic Review of Cleaning Validation Data

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the periodic review of cleaning validation data for aerosol manufacturing equipment. The purpose of this SOP is to ensure that cleaning validation remains effective and consistent over time, and that any changes to equipment, cleaning agents, or processes are thoroughly evaluated. Regular review of cleaning validation data helps to identify trends, potential risks, and opportunities for improvement in the cleaning process, ensuring continued compliance with Good Manufacturing Practices (GMP) and regulatory standards.

2. Scope

This SOP applies to the periodic review of cleaning validation data for all aerosol manufacturing equipment, including filling machines, pumps, nozzles, and any other components that come into contact with the product. The SOP covers the review of cleaning validation reports, test results, sampling data, and any corrective actions taken in response to deviations or failures in the cleaning process.

3. Responsibilities

• QA Team: Responsible for performing the periodic review of cleaning validation data, identifying trends and areas of concern, and ensuring compliance with GMP and regulatory requirements.
• Validation Team: Responsible for supporting the review process by providing historical validation data, test results, and corrective actions for any deviations that occurred during the cleaning validation process.
• Production Team: Responsible for providing feedback and any operational data that may be relevant to the periodic review of cleaning validation data.
• Regulatory Affairs Team: Ensures that the review process complies with applicable regulatory standards and guidelines.

4. Accountability

The Manufacturing Manager is accountable for ensuring that periodic reviews of cleaning validation data are conducted as per this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Frequency of Periodic Review

1. The periodic review of cleaning validation data should be conducted at least once every 12 months or more frequently if any of the following occur:
   • Changes are made to the cleaning process, equipment, or formulation
   • Deviations or non-conformities occur during the cleaning process
   • Regulatory requirements are updated
2. The review process should be initiated by the QA team based on the cleaning validation schedule or as needed, following significant changes in the production process or cleaning procedure.

5.2. Collecting Cleaning Validation Data

1. The following data should be collected for review:
   • Historical cleaning validation reports, including residue levels, sampling points, and test results (Annexure-1)
   • Deviation logs and corrective actions taken (Annexure-2)
   • Results of any revalidation or re-cleaning procedures performed
   • Trends in cleaning process performance, including any recurring issues or failures
   • Feedback from production and maintenance teams regarding the cleaning process and equipment performance
2. The data should be organized and reviewed to identify any deviations, trends, or areas for improvement in the cleaning process.

5.3. Review of Cleaning Validation Data

1. The QA team should review the collected cleaning validation data to evaluate the effectiveness of the cleaning process. The review should include:
   • Comparison of historical cleaning validation data with established acceptance criteria to verify that residues are consistently within acceptable limits.
   • Review of any deviations or failures in the cleaning process, including corrective actions taken and the effectiveness of those actions.
   • Analysis of trends in the cleaning process, such as recurring issues with certain equipment or surfaces, changes in residue levels over time, or changes in the cleaning process.
   • Evaluation of the adequacy of sampling points, sampling methods, and analytical test methods used in the cleaning validation process.
2. If any areas of concern or opportunities for improvement are identified during the review, corrective actions should be proposed and implemented.

5.4. Corrective Actions and Improvements

1. If the review identifies any deficiencies or areas for improvement, corrective actions should be taken. These may include:
   • Re-evaluating and updating the cleaning procedure to address any issues identified during the review.
   • Modifying or adding sampling points if necessary to ensure all critical areas are adequately cleaned and validated.
   • Re-validating the cleaning process or conducting additional cleaning runs if residue levels are found to exceed acceptable limits.
   • Implementing additional training for production or maintenance teams if recurring issues are linked to operational factors.
2. The corrective actions should be documented in the Deviation Log (Annexure-2) and monitored to ensure that the actions are effective in addressing the identified issues.

5.5. Reporting and Documentation

1. Once the review and corrective actions are completed, the results of the periodic review should be documented in the Periodic Review Report (Annexure-3). The report should include:
   • A summary of the data reviewed, including historical cleaning validation data and trends
   • Any deviations or issues identified during the review, including corrective actions taken
   • Recommendations for improvements to the cleaning process or procedures
   • A conclusion regarding the ongoing effectiveness of the cleaning validation process
2. The Periodic Review Report should be reviewed and approved by the QA team. Once approved, the report should be filed and stored as part of the cleaning validation documentation.

5.6. Revalidation and Continuous Improvement

1. Based on the periodic review results, revalidation of the cleaning process may be necessary if significant issues or trends are identified. Revalidation should follow the process outlined in the cleaning validation protocol, with updated sampling plans, test methods, and acceptance criteria as needed.
2. Ongoing monitoring and continuous improvement of the cleaning process should be encouraged to ensure that the equipment remains compliant with GMP and regulatory standards over time.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Periodic Review Report (Annexure-3)
2. Deviation Log (Annexure-2)
3. Cleaning Validation Report (Annexure-1)

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

11. Annexures

Annexure-1: Cleaning Validation Report

Annexure-2: Deviation Log

Annexure-3: Periodic Review Report

12. Revision History: