SOP for Preparing Batch Manufacturing Records for Aerosol Products

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing batch manufacturing records (BMR) for aerosol products. BMRs are critical for documenting the manufacturing process and ensuring that each batch of aerosol products is produced in compliance with regulatory standards, Good Manufacturing Practices (GMP), and company policies. This SOP outlines the steps involved in creating, reviewing, and maintaining accurate and complete BMRs for aerosol products.

2. Scope

This SOP applies to the preparation of batch manufacturing records for all aerosol products produced in the manufacturing facility. It covers the process from initial batch record creation to final review and approval, including the documentation of manufacturing steps, materials used, and test results.

3. Responsibilities

• Production Team: Responsible for preparing the batch manufacturing record during the production process. They ensure that all required information is documented accurately, including materials used, quantities, equipment used, and any deviations encountered during production.
• Quality Assurance (QA) Team: Responsible for reviewing the batch manufacturing record to ensure completeness, accuracy, and compliance with GMP and regulatory standards. The QA team also ensures that any deviations are properly documented and corrective actions are taken as needed.
• Engineering Team: Responsible for ensuring that any equipment used in the production process is functioning correctly and is properly documented in the batch manufacturing record.
• Warehouse Team: Responsible for ensuring that materials used in the batch are accurately tracked and documented in the BMR, and that the correct materials are available and used in the production process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that batch manufacturing records are prepared and maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing the Batch Manufacturing Record

1. Prior to the start of the manufacturing process, prepare a batch manufacturing record for the specific aerosol product to be produced. The BMR should include the following information:
   • Batch number
   • Product name and code
   • Manufacturing date and time
   • List of raw materials used, including their batch numbers and quantities
   • Equipment used (e.g., mixers, filling machines, etc.)
   • Production personnel involved in the process
   • Any relevant quality control or testing procedures to be performed
2. Ensure that the batch manufacturing record is aligned with the approved master batch record for the product, which includes the detailed manufacturing process steps and controls.
3. During the production process, ensure that all required data is entered into the batch manufacturing record. This includes:
   • Raw material lot numbers and quantities used
   • Equipment calibration and usage logs
   • Process parameters (e.g., temperature, pressure, mixing time) and any deviations observed
   • In-process testing results (e.g., weight checks, fill volume tests, etc.)
   • Any adjustments or deviations from the standard process and corrective actions taken

5.2. Documenting Deviation and Corrective Action

1. If any deviations from the standard process are encountered during production, they must be documented in the deviation section of the batch manufacturing record. The following information should be included:
   • A description of the deviation
   • The cause of the deviation (if known)
   • The corrective actions taken to address the deviation
   • Any impact on the final product or process
   • Approval of the corrective actions by the QA team
2. Ensure that any corrective actions taken are documented in the Corrective Action Log (Annexure-2) and that any necessary investigations are conducted to determine the root cause of the deviation.

5.3. Finalizing and Reviewing the Batch Manufacturing Record

1. Once the production process is complete, finalize the batch manufacturing record. Ensure that all sections of the BMR are filled out correctly, and that all required signatures are obtained, including signatures from production personnel, QA personnel, and any other relevant team members.
2. The QA team should perform a thorough review of the batch manufacturing record to ensure that it is complete, accurate, and in compliance with regulatory and GMP requirements. The review should include checking the following:
   • Completeness of the record
   • Accuracy of the data entered
   • Appropriate documentation of deviations and corrective actions
   • Verification of in-process test results
3. Once the QA team completes the review, the batch manufacturing record should be approved and signed off by the QA team. Any unresolved issues or deviations should be addressed before approval.

5.4. Archiving the Batch Manufacturing Record

1. Once the batch manufacturing record has been finalized and approved, it should be stored in a secure and organized manner for future reference, audits, or regulatory inspections.
2. Ensure that all batch manufacturing records are retained for the required duration according to company policy and regulatory requirements.
3. Make sure that batch records are accessible to authorized personnel when needed for audits, investigations, or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• QC: Quality Control

7. Documents

1. Batch Manufacturing Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Batch Manufacturing Record

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Ensuring Utility Compliance with Regulatory Standards

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a process for ensuring that utility systems in aerosol manufacturing comply with relevant regulatory standards. Regulatory compliance is critical for ensuring that utility systems, such as water, compressed air, gas, and HVAC, operate within the required parameters, supporting safe manufacturing practices and the consistent production of quality products. This SOP outlines the procedures for verifying that utility systems meet all regulatory requirements and documenting compliance efforts.

2. Scope

This SOP applies to all utility systems used in aerosol manufacturing, including water, compressed air, gas, HVAC, and other critical utilities. It covers the process for verifying that these systems comply with regulatory standards, including local and international requirements such as Good Manufacturing Practices (GMP), the Food and Drug Administration (FDA) guidelines, and any other applicable regulatory bodies.

3. Responsibilities

• Engineering Team: Responsible for ensuring that utility systems are designed, installed, and maintained in compliance with regulatory standards. The team is also responsible for conducting regular audits of utility systems to verify compliance.
• Maintenance Team: Responsible for ensuring that utility systems are maintained in accordance with regulatory requirements. They are also responsible for addressing any issues or failures in the utility systems that may affect regulatory compliance.
• Quality Assurance (QA) Team: Responsible for reviewing documentation, conducting audits, and ensuring that utility systems meet regulatory standards. The QA team also ensures that any non-compliance is identified and corrected in a timely manner.
• Production Team: Responsible for reporting any issues with utility systems that may affect production and ensuring that utilities are used in accordance with established procedures to maintain regulatory compliance.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are in compliance with regulatory standards. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Applicable Regulatory Standards

1. Review the relevant local and international regulatory guidelines, including GMP, FDA, and ISO standards, to determine the specific compliance requirements for each utility system used in aerosol manufacturing.
2. Identify any new regulatory requirements that may impact utility systems or manufacturing processes. Update internal procedures to ensure compliance with these regulations.
3. Ensure that all regulatory requirements are clearly documented and communicated to all relevant departments, including Engineering, Maintenance, Production, and QA.

5.2. Ensuring Compliance During Design and Installation

1. Ensure that utility systems are designed and installed according to the applicable regulatory standards. This includes verifying that the systems meet the required specifications for performance, safety, and environmental considerations.
2. Verify that all components of the utility systems, such as pipes, tanks, regulators, filters, and pumps, comply with the regulatory standards for materials, construction, and safety.
3. Conduct a review of the system’s design documentation to ensure it aligns with the regulatory requirements before installation begins.

5.3. Verifying Compliance During Operation

1. Monitor the performance of utility systems on a regular basis to ensure they are operating within the specified parameters. This includes measuring parameters such as water pressure, flow rates, gas purity, temperature, humidity, and system integrity.
2. Ensure that utility systems are inspected and maintained according to the regulatory standards and that all maintenance records are properly documented and up-to-date.
3. Conduct routine audits of utility systems to verify that they are being operated and maintained in compliance with regulatory requirements. These audits should be documented and reviewed by the QA team.

5.4. Documenting Compliance

1. Maintain accurate records of all utility system inspections, tests, and audits. These records should include:
   • Details of the system tested (e.g., water system, compressed air system)
   • Test results and measurements
   • Inspection and maintenance logs
   • Corrective actions taken for any non-compliance issues
   • Signatures of the personnel performing the tests and audits
2. Ensure that all compliance documentation is reviewed and approved by the QA team before being filed for archiving.
3. Archive all compliance-related records for the required duration as per regulatory requirements or company policies.

5.5. Correcting Non-Compliance

1. If non-compliance is identified during any inspection, audit, or test, document the issue in the Deviation Log (Annexure-2). This log should include:
   • A description of the non-compliance issue
   • The cause of the issue (if known)
   • Corrective actions taken to resolve the issue
   • The personnel responsible for the corrective actions
2. Implement corrective actions to resolve non-compliance issues and verify that the actions taken address the root cause. Once corrective actions are completed, verify that the system is operating in compliance with regulatory standards.
3. Once corrective actions are implemented, perform additional verification testing to ensure that the utility system meets regulatory standards. Document the results and update the Deviation Log.

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. Utility Compliance Verification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Utility Compliance Verification Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Verifying Utility System Performance During Process Changes

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a process for verifying the performance of utility systems during process changes in aerosol manufacturing. Any changes made to the manufacturing process may affect the performance of utility systems such as water, compressed air, gas, and HVAC systems. This SOP ensures that the performance of these systems is re-verified after process changes to confirm that they continue to meet the necessary specifications for safe and efficient production.

2. Scope

This SOP applies to all utility systems used in aerosol manufacturing, including water systems, compressed air systems, gas systems, and HVAC systems. The scope includes the verification of utility system performance following process changes, such as changes in production requirements, modifications to equipment, or regulatory updates, to ensure that the systems continue to function within the required operational parameters.

3. Responsibilities

• Engineering Team: Responsible for conducting the verification of utility systems during process changes, ensuring that all system parameters are tested and within the required specifications.
• Maintenance Team: Responsible for providing support during the verification process, ensuring that all utility systems are maintained and in proper working condition after process changes.
• Quality Assurance (QA) Team: Responsible for reviewing and approving all verification documentation to ensure compliance with GMP and regulatory standards.
• Production Team: Responsible for assisting in the verification process and reporting any issues or abnormalities in utility systems during production following a process change.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the utility system verification process is performed after any process changes. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Verification of Utility System Performance

1. Review the process change details and identify which utility systems may be impacted by the change. This may include changes in production requirements, equipment modifications, or regulatory updates.
2. Ensure that all necessary equipment for verifying utility system performance is available and calibrated. This includes pressure gauges, flow meters, temperature sensors, and any other testing instruments required for performance verification.
3. Establish the verification team, which should include representatives from Engineering, Production, and QA teams. All personnel involved in the verification process should be trained in the relevant procedures and standards.
4. Determine the specific performance parameters for each utility system that need to be verified following the process change. These may include pressure, flow rates, temperature, contamination levels, and system integrity.

5.2. Verifying Utility System Performance

1. The verification process should include the following key steps for each affected utility system:
   • Water Systems: Verify that water flow rates, pressure, and temperature are within the acceptable ranges. Perform microbial and particulate testing to ensure that water quality is maintained.
   • Compressed Air Systems: Verify that the compressed air pressure and flow rate are within the specified limits. Perform contamination testing to ensure that no particulate matter or oil is present in the system.
   • Gas Systems: Verify that gas pressure and flow rates are within the required ranges. Perform gas purity testing to ensure that no contaminants are present in the gas supply.
   • HVAC Systems: Verify that the HVAC system is maintaining the required temperature and humidity levels. Perform airflow and filtration efficiency testing to ensure compliance with the specifications.
2. Perform the necessary tests for each system under normal operating conditions to confirm that the system continues to meet the required performance standards after the process change.
3. Record all test results, including pressure readings, flow rates, temperature, contamination levels, and any deviations observed during testing. Document the results in the Utility Performance Verification Report (Annexure-1).

5.3. Documenting the Verification Results

1. Document the following information in the Utility Performance Verification Report (Annexure-1):
   • Utility system ID, model number, serial number, and installation location
   • Details of the process change and its potential impact on utility systems
   • The test methods, results, and comparison with acceptable limits
   • Any deviations observed and corrective actions taken
   • The name and signature of the personnel performing the verification tests
   • Approval signatures from the QA team
2. Ensure that all data entries are legible, accurate, and supported by the necessary calibration and testing equipment used during the verification process.

5.4. Reviewing and Approving the Verification Report

1. The QA team should review the Utility Performance Verification Report to ensure that all verification activities were carried out according to SOP requirements, and that the utility systems are performing within the required specifications.
2. If any deviations are found, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken to address the issues.
3. Once the verification report is complete and all deviations have been addressed, the QA team should approve the report.

5.5. Finalizing the Verification Process

1. After the verification process is completed and the utility systems are confirmed to be operating within the specified parameters, the systems are cleared for use in the production process.
2. Ensure that all verification documentation, including the Utility Performance Verification Report, Deviation Log, and Corrective Action Log, is archived for future audits and inspections.
3. Periodic verification of utility systems should be scheduled, based on the specific process change or as required by regulatory authorities, to ensure continued compliance with operational standards.

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. Utility Performance Verification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Utility Performance Verification Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Periodic Requalification of Utility Systems

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for the periodic requalification of utility systems in aerosol manufacturing. The validation and requalification of utility systems, such as water, air, compressed gases, and HVAC, are essential for maintaining the required operational standards and ensuring compliance with Good Manufacturing Practices (GMP). Periodic requalification ensures that utility systems continue to perform as expected and meet the necessary specifications for product quality and safety.

2. Scope

This SOP applies to all utility systems used in aerosol manufacturing, including water systems, compressed air systems, gas systems, and HVAC systems. The procedure covers the requalification of these systems, which occurs periodically or after any significant modifications or changes to system components, operation, or regulations that may affect their performance.

3. Responsibilities

• Engineering Team: Responsible for carrying out the requalification of utility systems, ensuring that all systems are operating within the required parameters and specifications.
• Maintenance Team: Responsible for ensuring that the utility systems are in good working condition before requalification and supporting any repairs or maintenance required during the requalification process.
• Quality Assurance (QA) Team: Responsible for reviewing, approving, and ensuring the accuracy of all requalification documentation. The QA team ensures that the systems meet regulatory standards and internal specifications.
• Production Team: Responsible for reporting any system issues that may affect manufacturing and for ensuring the utility systems operate properly during production cycles.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are requalified according to this SOP. The overall compliance with this SOP is monitored by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Periodic Requalification

1. Review the specifications and operational parameters for the utility systems to be requalified. This includes checking for any recent maintenance, repairs, or modifications that could impact system performance.
2. Ensure all requalification testing equipment, such as pressure gauges, flow meters, temperature sensors, and calibration tools, are available and properly calibrated for testing.
3. Verify that all necessary documentation is in place, including previous qualification records, maintenance logs, and system design specifications.
4. Establish a requalification team that includes personnel from Engineering, Maintenance, Production, and QA. All team members should be trained in the requalification process and standards.

5.2. Conducting the Periodic Requalification

1. The requalification process includes the following key activities:
   • Installation Qualification (IQ): Verify that the utility system is installed correctly according to the design specifications, ensuring that all components are functioning as intended.
   • Operational Qualification (OQ): Confirm that the system operates correctly under normal operational conditions. This includes testing critical parameters such as pressure, flow rates, and temperature to ensure they are within the specified limits.
   • Performance Qualification (PQ): Verify that the system performs consistently over time and under actual operating conditions, meeting the required specifications without deviation.
   • System Integrity Test: Ensure that the system does not have leaks or failures that could impact performance. This includes testing pressure retention, flow rates, and confirming system integrity across all components.
   • Contamination Control Test: Verify that the utility system does not introduce contaminants into the production process. This includes testing for microbial contamination, particulate matter, and any other potential impurities.
2. During the requalification, ensure that all performance tests are conducted under normal production conditions to verify that the utility systems can reliably meet operational demands.
3. Record all test results, including pressure readings, flow rates, temperatures, and any deviations from expected performance. This documentation should be included in the Utility Requalification Report (Annexure-1).

5.3. Documenting the Requalification Results

1. Document all requalification results in the Utility Requalification Report (Annexure-1). The report should include:
   • System ID, model number, serial number, and location
   • Test methods, results, and comparison with acceptable ranges
   • Any deviations or non-conformities observed during testing and any corrective actions taken
   • The names and signatures of the personnel performing the requalification
   • Approval signatures from the QA team
2. Ensure that all test results are clearly documented and that any discrepancies or issues are addressed and documented with corrective actions.

5.4. Reviewing and Approving the Requalification Report

1. The QA team should review the Utility Requalification Report for completeness and accuracy, ensuring that the requalification process was carried out according to SOP requirements and that the system meets all regulatory and operational standards.
2. If any deviations are found, document them in the Deviation Log (Annexure-2) and perform corrective actions to resolve the issue. Ensure that any deviations are addressed before the report is approved.
3. Once all corrective actions are complete and the report is finalized, the QA team should approve the requalification report.

5.5. Finalizing the Requalification Process

1. After the utility system passes requalification, it is considered qualified and may be used for production without restrictions. Ensure that the system is clearly labeled with the requalification date and the next due date for requalification.
2. Archive all requalification documentation, including the Utility Requalification Report, Deviation Log, and any Corrective Action Reports, for future audits and inspections.
3. Schedule periodic requalification according to regulatory requirements or after significant system changes or maintenance, ensuring the system remains in a qualified state.

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. Utility Requalification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Utility Requalification Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Documenting Utility Validation Data

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for documenting utility validation data in aerosol manufacturing. Proper documentation of utility validation is critical to demonstrate compliance with regulatory requirements and ensure that utilities (such as water, compressed air, gas, and electricity) are functioning within the specified parameters for safe and effective manufacturing operations. This SOP provides a structured approach for recording validation data, including the methods for testing, documentation standards, and review procedures.

2. Scope

This SOP applies to all utilities used in aerosol manufacturing processes, including water systems, compressed air systems, HVAC, and other systems that are critical to the production environment. The scope includes documentation requirements for utility qualification, including installation, operational, and performance qualification data, and all associated records related to validation testing and results.

3. Responsibilities

• Engineering Team: Responsible for performing utility system validations, including data collection during qualification tests, and ensuring that the utility systems meet the required specifications.
• Quality Assurance (QA) Team: Responsible for reviewing and approving all validation documentation to ensure compliance with GMP and regulatory standards.
• Production Team: Responsible for reporting any issues or deviations related to utility systems that could affect product quality and ensuring that all utility-related procedures are followed during production.
• Maintenance Team: Responsible for maintaining utility systems, ensuring their continued operational functionality, and supporting the documentation of any maintenance activities affecting system performance.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are properly validated and that documentation is maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Utility Validation Documentation

1. Ensure that the utility validation is conducted according to the manufacturer’s specifications and relevant standards for each utility system. The validation process should include:
   • Installation Qualification (IQ): Verify that the utility system has been installed according to specifications and design requirements.
   • Operational Qualification (OQ): Verify that the system operates within the specified parameters under normal operating conditions.
   • Performance Qualification (PQ): Confirm that the system performs as expected over an extended period and under actual operating conditions.
2. During each qualification phase, collect relevant data that demonstrates the system is functioning as intended. This data may include:
   • Flow rates, pressures, temperatures, and other performance indicators
   • Test results from system performance checks
   • Maintenance records, including any corrective actions taken
3. Ensure that all data is recorded in a structured and consistent manner, following the approved templates and formats for utility validation documentation.

5.2. Data Collection and Entry

1. For each utility system, create a dedicated data log to record test results and performance data. The log should include:
   • System ID, installation location, and operational parameters
   • The test type (e.g., temperature, pressure, flow rate) and corresponding results
   • The name and signature of the personnel performing the validation tests
   • The date and time of each test
2. Ensure that all data entries are legible, accurate, and supported by any relevant calibration or testing equipment used. Any deviations from expected results should be documented and investigated.
3. All logs should be signed by the responsible personnel and reviewed by the QA team for completeness and compliance with regulatory requirements.

5.3. Documentation Review and Approval

1. Once the utility validation data has been collected and entered into the system, the documentation should be reviewed by the QA team for compliance with internal and regulatory standards.
2. The QA team should ensure that:
   • The utility systems meet the necessary specifications for functionality and performance
   • All required tests were performed and the results are within the acceptable ranges
   • Any deviations or corrective actions taken are properly documented
3. Once reviewed, the QA team should approve the documentation and sign off on the validation records. Any unresolved issues should be addressed before final approval.

5.4. Archiving and Retention of Validation Data

1. Once approved, all utility validation data should be stored in a secure, accessible location for future reference and audits.
2. Ensure that all validation records are retained for the required duration, in accordance with regulatory requirements and company policies.
3. Implement a system for retrieving and reviewing validation records during internal audits, regulatory inspections, or whenever necessary to demonstrate compliance with GMP standards.

5.5. Periodic Review of Utility Systems

1. Periodic reviews of the utility systems should be conducted to ensure they continue to perform as required. This includes requalification testing and ensuring that the documentation remains up-to-date with any changes to the utility systems.
2. Any changes or updates to the utility systems that impact performance, compliance, or validation status should be documented and reviewed in the Change Control Log (Annexure-2).

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. Utility Validation Data Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Utility Validation Data Log

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Validating Propellant Supply Systems

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for validating propellant supply systems used in aerosol manufacturing. Propellants are a critical component of aerosol products, and the performance of the propellant supply system directly affects the quality, consistency, and safety of the final product. This SOP ensures that the propellant supply system is validated to meet all required specifications for performance, reliability, and safety, and complies with GMP and regulatory standards.

2. Scope

This SOP applies to all propellant supply systems used in aerosol manufacturing, including systems for storing, transferring, and dispensing propellants. The scope covers the entire validation process, including installation, operational, and performance qualification, to ensure the system consistently delivers propellants within the required specifications.

3. Responsibilities

• Engineering Team: Responsible for overseeing the installation, maintenance, and qualification of the propellant supply system. They ensure that the system is properly designed, installed, and operating within specified parameters.
• Maintenance Team: Responsible for maintaining the propellant supply system and ensuring it operates efficiently and safely. They are also responsible for addressing any issues identified during qualification or operational monitoring.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the qualification process to ensure that the system meets regulatory and GMP requirements, and for ensuring that any deviations are appropriately documented and addressed.
• Production Team: Responsible for assisting in the qualification process, ensuring that the propellant supply system operates correctly during manufacturing, and reporting any abnormalities or failures that could impact product quality.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the propellant supply system is qualified in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Propellant Supply System Validation

1. Ensure that the propellant supply system is installed and ready for qualification. This includes verifying that all components, such as storage tanks, transfer lines, valves, regulators, and dispensing equipment, are properly installed and functioning as intended.
2. Review the system’s design specifications, including the expected flow rates, pressure settings, and safety requirements. Ensure that the system meets the required specifications for storing and dispensing propellants.
3. Verify that the system has been maintained according to the manufacturer’s recommendations and internal maintenance schedules. Document any recent repairs, adjustments, or upgrades made to the system.
4. Ensure that all required calibration equipment is available, including flow meters, pressure gauges, and any other instrumentation required for testing the propellant supply system’s performance.
5. Establish the qualification team, which should include representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in propellant supply system qualification procedures and understand the specifications and requirements for the system.

5.2. Performing the Propellant Supply System Validation

1. The validation process should include the following steps to ensure that the system meets the required performance and safety standards:
   • Installation Qualification (IQ): Verify that the propellant supply system is installed correctly and meets the required specifications. This includes confirming that all components are free from defects, properly connected, and in good working condition.
   • Operational Qualification (OQ): Verify that the system operates according to the specified parameters. Perform tests on the flow rate, pressure, and dispensing accuracy of the system to ensure that it meets design specifications.
   • Performance Qualification (PQ): Test the system’s ability to consistently deliver propellant within the required parameters over a series of operational cycles. This should include verification of system performance under normal and peak production conditions, as well as testing the system’s ability to maintain the desired pressure and flow rates during continuous use.
   • Leak Test: Perform a leak test to ensure that there are no leaks in the propellant supply system. This is critical to ensure the safe and efficient transfer of propellant to aerosol containers without loss or contamination of propellant.
   • Contaminant Test: Verify that the system does not introduce contaminants into the propellant. Perform testing to ensure that the transfer lines and dispensing equipment are free from particulate matter, oils, and other contaminants that could affect product quality.
2. Record all test results, including measured values, test conditions, and any deviations observed. Document the results in the Propellant Supply System Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the Propellant Supply System Validation Report (Annexure-1):
   • System ID, model number, serial number, and installation location
   • The test methods and equipment used for validation
   • The results of each test performed, including pressure readings, flow rates, leak test results, and any deviations or non-conformities
   • The name and signature of the personnel performing the validation tests
   • 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 completeness and accuracy.

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Propellant Supply System Validation Report to ensure that the system meets all operational and safety requirements, and that it consistently delivers propellant within the required specifications.
2. If any deviations are identified during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken. Ensure that all deviations are addressed before approval.
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 system has been successfully validated, it is considered ready for use in the aerosol manufacturing process. The system can now be used for production activities without restriction.
2. All documentation, including the Propellant Supply System Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic revalidation of the propellant supply system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

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. Propellant Supply System Validation Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Propellant Supply System Validation Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Calibration of Pressure Gauges in Utility Systems

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the calibration of pressure gauges used in utility systems in aerosol manufacturing. Pressure gauges are critical instruments in monitoring and maintaining proper operating conditions, ensuring that pressure levels are within the required range for safe and efficient manufacturing operations. This SOP ensures that pressure gauges are accurately calibrated to maintain the reliability and accuracy of pressure measurements, contributing to product quality and safety compliance.

2. Scope

This SOP applies to all pressure gauges used in utility systems involved in aerosol manufacturing, including systems for water, air, gas, and steam. It covers the calibration process, including the procedures for verification, adjustment, and documentation to ensure that all pressure gauges meet the specified calibration standards.

3. Responsibilities

• Engineering Team: Responsible for performing the calibration of pressure gauges, ensuring that all instruments are calibrated in accordance with this SOP and the manufacturer’s instructions.
• Maintenance Team: Responsible for providing support in the calibration process, including ensuring that pressure gauges are in good working condition and reporting any issues that may require repair or replacement.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the calibration results and ensuring that the calibration process complies with GMP and regulatory standards.
• Production Team: Responsible for reporting any abnormal pressure readings that may indicate a malfunction in the pressure gauges, and for ensuring that pressure levels are within acceptable limits during production.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all pressure gauges are calibrated according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Calibration

1. Ensure that the pressure gauge is free from damage and functioning properly. Verify that the gauge is connected to the utility system and is in the appropriate condition for calibration.
2. Verify that the necessary calibration equipment is available and properly calibrated. This includes comparison standards, calibration kits, and pressure sources such as hand pumps or calibration rigs.
3. Review the manufacturer’s specifications for the pressure gauge to determine the calibration range and tolerances required for the specific application.
4. Establish the calibration team, which should include representatives from the Engineering, Maintenance, and QA teams. Ensure that personnel are trained in calibration procedures and understand the required standards.
5. Ensure that the calibration area is clean and free of any contaminants that could affect the calibration process. All instruments and equipment should be properly labeled and easily identifiable.

5.2. Performing the Calibration

1. Begin the calibration process by verifying the zero reading of the pressure gauge. This ensures that the gauge reads accurately when there is no pressure applied.
2. Apply a known reference pressure to the gauge being calibrated. Use a calibrated pressure source, such as a pressure calibrator or dead weight tester, to ensure that the applied pressure is accurate.
3. Record the reading on the pressure gauge at multiple pressure points within the specified range. Compare the gauge’s readings with the reference pressure and verify that they are within the acceptable tolerance limits.
4. If the readings are outside the tolerance limits, adjust the pressure gauge according to the manufacturer’s instructions to bring it into alignment with the reference pressure.
5. Repeat the process for multiple pressure points (e.g., low, medium, and high pressure) to ensure accuracy across the entire range of the pressure gauge.
6. If the pressure gauge cannot be calibrated to the specified tolerance limits, report the issue and remove the gauge from service for repair or replacement.

5.3. Documenting the Calibration Results

1. Document the calibration results in the Calibration Record (Annexure-1). The record should include the following information:
   • Pressure gauge ID, model number, serial number, and location
   • Calibration date and time
   • The reference pressure values applied during calibration and the readings of the gauge at each pressure point
   • Any deviations observed during calibration and corrective actions taken (if applicable)
   • The name and signature of the personnel performing the calibration
   • Approval signatures from the QA team
2. Ensure that all calibration results are accurate, complete, and easy to review. Any deviations from the expected results should be thoroughly documented and addressed.

5.4. Reviewing and Approving the Calibration Report

1. The QA team should review the Calibration Record to ensure that all calibration activities were performed according to this SOP and that the gauge is operating within the specified tolerance limits.
2. If any deviations were observed during calibration, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken to address the issue.
3. The QA team should approve the calibration report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the Calibration Process

1. Once the calibration is complete, the pressure gauge is returned to service and marked with the calibration date and the next due date for re-calibration.
2. Ensure that all documentation, including the Calibration Record, Deviation Log, and any corrective actions, is archived for future audits and inspections.
3. Periodic re-calibration of pressure gauges should be scheduled as per the manufacturer’s recommendations or regulatory requirements to ensure continuous accuracy.

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. Calibration Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 9001: Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Calibration Record

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Water System Validation for Aerosol Manufacturing

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the guidelines for validating the water systems used in aerosol manufacturing areas. Water is a critical component in aerosol manufacturing, used in formulation preparation, cleaning, and other manufacturing processes. The SOP ensures that water systems are qualified to meet the required standards of quality and safety, and comply with regulatory and GMP requirements, ensuring no contamination of the product.

2. Scope

This SOP applies to all water systems used in aerosol manufacturing processes, including water for injection (WFI) systems, purified water systems, and water used for cleaning. It covers the entire validation process, from installation through operational and performance qualifications, to ensure the system produces water of the required quality and meets the operational specifications.

3. Responsibilities

• Engineering Team: Responsible for overseeing the installation, operation, and qualification of the water system. They ensure that the system is properly designed, maintained, and meets the required standards.
• Production Team: Responsible for ensuring that the water system operates as intended during manufacturing, and reporting any issues that could affect the system’s performance.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the water system qualification process and ensuring that the system complies with GMP and regulatory requirements.
• Maintenance Team: Responsible for the ongoing maintenance of the water system, ensuring it operates efficiently and meets the necessary quality standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the water system is validated and maintained in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Water System Validation

1. Ensure that the water system has been installed correctly and is fully operational. This includes verifying that all components of the system, including filtration units, pumps, pipes, and tanks, are installed according to the specifications.
2. Review the design specifications of the water system, including the flow rates, capacity, water quality standards (e.g., conductivity, pH, microbial content), and operational parameters. Verify that the system meets the required specifications for the intended use.
3. Ensure that all maintenance, calibration, and operational procedures for the system are up to date.
4. Establish the validation team, which should include representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in water system qualification procedures and standards.
5. Verify that water used in the system is compliant with the necessary standards (e.g., USP, EP) and is free of contaminants, ensuring no adverse impact on product quality.

5.2. Conducting Water System Validation

1. The water system validation should include the following tests to ensure that the system produces water that meets the required quality and operates effectively:
   • Installation Qualification (IQ): Verify that the system has been installed correctly according to design specifications. Ensure that all components, including filtration units and water storage tanks, are functioning as intended and free from defects.
   • Operational Qualification (OQ): Test the operational performance of the system, including verifying flow rates, pressure, and temperature under normal operating conditions. Ensure that the system provides water at the specified flow rate and pressure, and that temperature is within the acceptable range.
   • Performance Qualification (PQ): Perform testing to confirm that the system consistently produces water of the required quality (e.g., conductivity, pH, microbial content). Perform microbial and chemical testing on water samples to verify compliance with specifications. Verify that the system meets water quality standards over the specified production cycles.
   • Contaminant Test: Test for contaminants in the water, including total organic carbon (TOC), microbial levels, and endotoxins. Ensure that all contamination levels are within the acceptable limits for manufacturing requirements.
   • System Integrity Test: Verify that the entire water distribution system is free of leaks and can maintain pressure without loss of performance. Perform leak tests on pipes, joints, and other system components.
2. Record all test results, including measured values, test conditions, and any deviations observed. Document the results in the Water System Qualification Report (Annexure-1).

5.3. Documenting the Qualification Results

1. Document the following information in the Water System Qualification Report (Annexure-1):
   • System ID, model number, and installation location
   • The test methods and equipment used for qualification
   • The results of each test performed, including water quality results (e.g., TOC, pH, microbial levels), flow rates, and pressure readings
   • The name and signature of the personnel performing the qualification tests
   • Approval signatures from the QA team
2. Ensure that the qualification report is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.

5.4. Reviewing and Approving the Qualification Report

1. The QA team should review the Water System Qualification Report to ensure that the system meets all operational and quality requirements, and that it consistently produces water that meets the necessary standards.
2. If any deviations are identified during the qualification process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken. Ensure that all deviations are addressed before approval.
3. The QA team should approve the report once all qualification activities are complete and any deviations have been addressed.

5.5. Finalizing the Qualification Process

1. Once the water system has been successfully validated, it is considered qualified and ready for use in the aerosol manufacturing process. The system can now be used for production activities.
2. All documentation, including the Water System Qualification Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic requalification of the water system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

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. Water System Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• USP <1231> Water for Pharmaceutical Purposes

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Water System Qualification Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Validating HVAC Systems in Aerosol Manufacturing Areas

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for validating Heating, Ventilation, and Air Conditioning (HVAC) systems used in aerosol manufacturing areas. HVAC systems are critical for maintaining environmental conditions within acceptable limits for the production of aerosol products, particularly to control temperature, humidity, and air quality. This SOP ensures that HVAC systems are validated to meet operational requirements and regulatory standards, guaranteeing a controlled environment conducive to the production of quality products.

2. Scope

This SOP applies to the HVAC systems installed in all aerosol manufacturing areas, including production floors, storage rooms, and packaging areas. It covers the validation process, including performance testing, operational qualification, and acceptance criteria to ensure that the HVAC system functions properly and meets the necessary environmental control specifications.

3. Responsibilities

• Engineering Team: Responsible for overseeing the HVAC system installation, maintenance, and qualification. They ensure that the system is fully operational and that the qualification process is conducted accurately.
• Maintenance Team: Responsible for maintaining the HVAC system and performing any necessary repairs or adjustments during the qualification process.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the HVAC system validation documentation, ensuring compliance with GMP and regulatory standards.
• Production Team: Responsible for reporting any issues related to HVAC performance and assisting with validation activities when necessary.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the HVAC system is validated according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for HVAC System Validation

1. Ensure that the HVAC system is installed and fully operational in the aerosol manufacturing area. Verify that all components, such as air filters, humidifiers, heaters, and ventilation fans, are working as expected.
2. Review the HVAC system’s design specifications and operational parameters, including temperature, humidity, airflow rates, filtration efficiency, and pressure differentials between controlled and non-controlled areas.
3. Verify that the HVAC system has been maintained according to the manufacturer’s recommendations and internal maintenance schedules. Document any recent repairs, adjustments, or upgrades performed on the system.
4. Establish the validation team, which should include representatives from Engineering, QA, and Production teams. Ensure that all personnel involved are trained in HVAC validation processes and standards.

5.2. Conducting HVAC System Validation

1. The HVAC system validation process should include the following tests:
   • Temperature Control Test: Verify that the HVAC system maintains the required temperature range (e.g., 20°C to 25°C) throughout the manufacturing area. Test temperature at multiple locations within the area to ensure uniformity.
   • Humidity Control Test: Verify that the system maintains the required humidity levels (e.g., 40% to 60%) and that there are no fluctuations that could impact the quality of the aerosol products. Use calibrated hygrometers to measure humidity at various points.
   • Airflow Test: Measure the airflow rate through the HVAC system, ensuring it meets the specified design parameters. This includes verifying that the air changes per hour (ACH) are adequate to ensure proper ventilation and that air distribution is uniform across the room.
   • Filtration Efficiency Test: Verify that the HVAC system’s air filters effectively remove particulates, microorganisms, and other contaminants from the air. Use particle counters or microbial samplers to assess filter efficiency.
   • Pressure Differential Test: Check the pressure differentials between the controlled environment and adjacent areas to ensure that airflow is in the correct direction (e.g., from clean areas to less clean areas). This prevents the contamination of controlled environments.
2. During testing, ensure that the HVAC system is running under normal operating conditions and that all measurements are taken at the specified times and locations.
3. Record all test results, including the measured values, test conditions, and any deviations observed. Document the results in the HVAC System Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the HVAC System Validation Report (Annexure-1):
   • HVAC system ID, model number, serial number, and installation location
   • The test methods and equipment used for validation
   • The results of each test performed, including temperature, humidity, airflow rate, filtration efficiency, and pressure differential
   • The name and signature of the personnel performing the validation tests
   • 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 HVAC System Validation Report to ensure that the system meets all operational and cleanliness requirements, and that the system functions as expected under normal operating conditions.
2. If any deviations are identified during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be implemented as necessary.
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 HVAC system is validated, it is considered qualified and ready for use in the aerosol manufacturing process. The system can be used without restrictions for production activities.
2. All documentation, including the HVAC System Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic revalidation of the HVAC system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

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. HVAC System Validation Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 14644 – Cleanrooms and associated controlled environments

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: HVAC System Validation Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History:

SOP for Qualification of Compressed Air Systems for Aerosols

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the requirements and procedures for qualifying the compressed air systems used in aerosol manufacturing. Compressed air systems play a critical role in aerosol production, especially in equipment operations such as filling machines, actuators, and cleaning processes. This SOP ensures that the compressed air system is validated to meet quality and regulatory requirements, providing contamination-free, reliable, and consistent performance.

2. Scope

This SOP applies to the qualification of all compressed air systems used in aerosol manufacturing facilities, including air compressors, air filtration units, regulators, and associated distribution systems. The qualification process verifies that the system delivers compressed air within the required parameters and meets operational, cleanliness, and safety standards. It applies to new installations, modifications, and requalification after maintenance or repairs.

3. Responsibilities

• Engineering Team: Responsible for overseeing the qualification of the compressed air system, ensuring that all tests are performed and that the system meets specified standards for performance and safety.
• Maintenance Team: Responsible for ensuring that the compressed air system is well-maintained and that any repairs or modifications are documented and evaluated for impact on system qualification.
• Production Team: Responsible for reporting any operational issues related to the compressed air system and ensuring that the system functions properly during production.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the compressed air system qualification report to ensure that it complies with GMP and regulatory requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the compressed air system is qualified and maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Compressed Air System Qualification

1. Ensure that the compressed air system is fully installed, operational, and ready for qualification testing. This includes the compressor, air filters, regulators, piping, and any other components involved in the compressed air supply.
2. Verify that all components of the system have been installed according to the manufacturer’s specifications, and that the system is free from any leaks or damage.
3. Review the equipment’s technical specifications to understand the required performance parameters, including air flow rate, pressure, temperature, and cleanliness standards.
4. Ensure that the compressed air system is equipped with appropriate filtration to remove particulates, oils, and other contaminants from the air supply, in line with industry standards.
5. Establish the qualification team, including representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in the qualification process and familiar with the equipment and specifications.

5.2. Performing the Compressed Air System Qualification

1. The qualification process should include the following tests to ensure that the compressed air system meets the required standards:
   • Airflow and Pressure Test: Verify that the air supply meets the required airflow rate and pressure. This should be done under both normal and peak production conditions. Measure the pressure at key points throughout the system and ensure that it is within the acceptable range.
   • Purity and Cleanliness Test: Verify that the compressed air is free from contaminants, including particulates, oils, and moisture. Use appropriate air quality testing methods such as particle counters and moisture detectors to assess air purity. Compare results to regulatory standards for clean air in manufacturing environments (e.g., ISO 8573 standards).
   • Leak Test: Perform a leak test on the compressed air system to ensure that there are no air leaks in the system, which could affect performance or result in contamination. Use ultrasonic leak detection equipment or other methods to identify and correct any leaks.
   • Temperature Test: Verify that the temperature of the compressed air is within the specified range, typically between 15°C and 25°C. Excessive temperatures can affect the quality of the product and the operation of equipment.
   • Backup System Test: Verify that the backup air supply system, if applicable, functions as intended during system downtime or in case of failure of the primary air compressor.
2. Record all test results, including measured values, test conditions, and any deviations from the specified parameters. Document the results in the Compressed Air System Qualification Report (Annexure-1).

5.3. Documenting the Qualification Results

1. Document the following information in the Compressed Air System Qualification Report (Annexure-1):
   • System ID, compressor model, and serial number
   • Test methods and acceptance criteria used during qualification
   • The results of each test performed, including any deviations or non-conformities
   • Corrective actions taken to address any deviations or issues observed during the qualification process
   • The name and signature of the personnel performing the qualification tests
   • Approval signatures from the QA team
2. Ensure that the qualification report is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.

5.4. Reviewing and Approving the Qualification Report

1. The QA team should review the Compressed Air System Qualification Report to ensure that the system meets all operational and cleanliness requirements and that the system functions as expected under normal and peak conditions.
2. If any deviations are identified during the qualification 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 qualification activities are complete and any deviations have been addressed.

5.5. Finalizing the Qualification Process

1. Once the system has been successfully qualified, it is considered ready for use in the aerosol manufacturing process. The system can now be used for production without restriction.
2. All documentation, including the Compressed Air System Qualification Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic requalification of the compressed air system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

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. Compressed Air System Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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
• ISO 8573 – Compressed Air Quality Standards

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Compressed Air System Qualification Report

Annexure-2: Deviation Log

Annexure-3: Corrective Action Log

12. Revision History: