The qualification of equipment in the manufacturing of pharmaceuticals is an organized approach to confirm that the systems perform as expected. When equipment passes the Factory Acceptance Testing (FAT) at the vendor's location, it is tested again when installed at the manufacturing site. This testing is referred as the Site Acceptance Testing (SAT).
The completion of SAT marks a significant event that links the installation of equipment and its qualification. It allows for verification that the equipment, utility, and control systems work correctly within their intended final production environment.
In this article, we will outline what SAT stands for, what its goals are, its test protocols, how to document SAT results and its relationship to the requirements for Good Manufacturing Practices (GMP).
The SAT is performed once the equipment has been delivered to the user site, installed, and connected to utility systems but before any user qualification testing. The FAT is the testing performed by the manufacturer at the manufacturer site to confirm the equipment or system will perform as intended in the actual plant environment.
1. Verify that all equipment and systems were properly installed according to the layout & design drawings.
2. Confirm that the equipment or system functions correctly with the site utilities, such as electricity, compressed air and water in a real world production environment.
3. Make sure that all equipment and systems are running meeting all end user specifications (URS) after shipment and installation completion.
4. Verify that all equipment is fully integrated with other systems.
5. Verify that all alarms, emergency systems and interlocks are functioning correctly within the production facility of the site.
6. Ensure that all equipment(systems) and automation systems have all necessary documentation and performance data available thus preparing to enter the IQ and OQ phases.
The SAT provides assurance that the equipment and automation systems are “ready to qualify” and safe to operate in the production environment.
The key components of the SAT protocol include the following:
1. Objective and Scope: This outlines the equipment or system being tested and what the is the intent of this test.
2. Responsibilities: This identifies the roles and responsibilities of the vendor, engineering, validation and QA departments.
3. Equipment Description: This details the make, model, serial number and general functional capability of the equipment or system.
4. Reference Documentation: This includes URS, FAT report, P&IDs, wiring diagrams, software specification etc.
5. Test Methodology: This outlines a detailed step-by-step process to execute all tests on the equipment or system.
6. Acceptance Criteria: This has the acceptance limits for each test to know whether the test has passed or failed.
7. Deviation Management: This outlines the handling procedure of test failures or findings.
8. Documentation and Signatures: This includes the results, certificates and authorized sign-off from QA.
After the SAT is complete the SAT report will be evaluated by the QA department for approval. The SAT report will be used as a deliverable for the subsequent phases of equipment or system qualification.
2. The pipe connections, electrical cable connections and ancillary (from other trades) mounts and supports were properly installed.
3. The identification nameplates, pressure gauges and other identification tags were installed as required.
2. Check to see if the flow rates, pressure and temperature of the fluids are at acceptable levels for the equipment being tested.
2. Perform a safety inspection on each sensor, alarm, and interlock; verify that they all function properly and will respond within the limits provided for equipment safety.
3. Ensure that the functions and automation of the equipment are performed in accordance with client's specifications (design).
2. 21 CFR Part 11 and GAMP 5 requirements must be verified.
3. Ensure that the communication is valid between SCADA or MES and the equipment.
2. Record the important operating parameters such as speed, pressure, temperature and flow rate.
3. After completion of the functional and performance tests make comparisons with acceptance criteria.
2. Review all instruments' certificates, the electrical (AC and DC) connection wiring diagrams and a list of all software backed up.
3. Verify that spare parts list and any maintenance information related to the equipment are available.
Vendor responsible for preparation and implementation of SAT protocols, providing test equipment and trained personnel, providing assistance with troubleshooting if needed during testing and providing completed SAT report and supporting data to customers.
Customer Responsible for reviewing and signing off on SAT protocols before testing, observing tests and documenting their observations, making decisions regarding whether tests passed or failed based on acceptance criteria and providing acknowledgment that sat has been completed.
EU GMP Annex 15 - Verifying equipment performance after installation must occur.
ISPE Baseline Guide - FAT & SAT are included in the commissioning and qualification life cycle for any systems.
GAMP 5 - Defines expectations for how computerized & automated systems are to be validated.
USFDA 21 CFR Part 211 - Properly installed, calibrated, and operated equipment is mandated by this regulation.
During GMP inspections, SAT results (and deviations) will be included in the qualification documentation reviewed.
2. Use your approved FAT results to establish your SAT protocol.
3. Make sure that everything you measure is traceably calibrated using approved measuring devices.
4. Make a complete record of all existing utilities and environmental conditions at the jobsite.
5. Bring in Quality Assurance early in the process, their presence will give credibility to all of your data and ensure that your General Manufacturing Practice responsibilities are met.
6. Create photo, video or other documentary evidence of your validation process including test reports.
7. Attempt to resolve all deviation issues raised by qualification before moving forward with that qualification.
8. Archive and retain all SAT related documents securely for future audit purposes.
2. Identifies potential product defects at an early stage minimizing time spent waiting for qualification.
3. SAT also establishes a foundation of confidence in the equipment's reliability.
4. SAT provides the company with training opportunities for plant personnel who will operate and maintain the equipment.
5. Helps to prepare for inspections and compliance with all regulatory criteria.
SAT is an essential step in qualifying pharmaceutical equipment. With SAT, customers can verify that their installed system is capable of performing well under actual operating conditions while meeting both GMP and Safety regulations.
Through the verification of installation integrity, control system performance, and data integrity, SAT sets the stage for successful qualification and readiness for production.
Ultimately, a successful SAT will help ensure that quality, compliance, and performance are all built into the equipment before the production of any batches.
In this article, we will outline what SAT stands for, what its goals are, its test protocols, how to document SAT results and its relationship to the requirements for Good Manufacturing Practices (GMP).
What is a Site Acceptance Test (SAT)?
Site Acceptance Test (SAT) is performed at user location. SAT tests that all site connections like electrical supply, utilities and integrated software are working correctly and that the equipment or system is performing as intended and approved by the manufacturer.The SAT is performed once the equipment has been delivered to the user site, installed, and connected to utility systems but before any user qualification testing. The FAT is the testing performed by the manufacturer at the manufacturer site to confirm the equipment or system will perform as intended in the actual plant environment.
Objectives of Site Acceptance Test
The primary objectives of a Site Acceptance Test (SAT) in the pharmaceutical industry are:1. Verify that all equipment and systems were properly installed according to the layout & design drawings.
2. Confirm that the equipment or system functions correctly with the site utilities, such as electricity, compressed air and water in a real world production environment.
3. Make sure that all equipment and systems are running meeting all end user specifications (URS) after shipment and installation completion.
4. Verify that all equipment is fully integrated with other systems.
5. Verify that all alarms, emergency systems and interlocks are functioning correctly within the production facility of the site.
6. Ensure that all equipment(systems) and automation systems have all necessary documentation and performance data available thus preparing to enter the IQ and OQ phases.
The SAT provides assurance that the equipment and automation systems are “ready to qualify” and safe to operate in the production environment.
Scope of Site Acceptance Test
The SAT includes a variety of areas based on your system's level of sophistication. Common SAT activities may include the following:- Verify the correct wiring and installation of electric & instrumented equipment (i.e. correct connections have been made).
- Power-up the automated control system and confirm that the system is operating normally.
- Ensure that the alarm, interlocking and safety functions are working properly.
- Verify the integrity of all automation functional and operational software.
- Verify all communications between automated control systems.
- Functional performance of the equipment while it is in normal operation conditions should be documented.
- Ensure that all sensors & probes are functioning correctly and are calibrated.
- Review all documentation related to installation of the automated control systems.
- Ensure required documentation for equipment is complete and in order.
SAT Protocol & Documentation
The provision of a fully disclosed and agreed on testing protocol provides a framework for the testing of the equipment/system and promotes traceability of all testing results. The SAT protocol is prepared by the vendor and the end user’s validation/QA department together.The key components of the SAT protocol include the following:
1. Objective and Scope: This outlines the equipment or system being tested and what the is the intent of this test.
2. Responsibilities: This identifies the roles and responsibilities of the vendor, engineering, validation and QA departments.
3. Equipment Description: This details the make, model, serial number and general functional capability of the equipment or system.
4. Reference Documentation: This includes URS, FAT report, P&IDs, wiring diagrams, software specification etc.
5. Test Methodology: This outlines a detailed step-by-step process to execute all tests on the equipment or system.
6. Acceptance Criteria: This has the acceptance limits for each test to know whether the test has passed or failed.
7. Deviation Management: This outlines the handling procedure of test failures or findings.
8. Documentation and Signatures: This includes the results, certificates and authorized sign-off from QA.
After the SAT is complete the SAT report will be evaluated by the QA department for approval. The SAT report will be used as a deliverable for the subsequent phases of equipment or system qualification.
Site Acceptance Test Activities
Some types of equipment may involve different processes to complete SAT. However, most SATs share several core process categories as follows:A. Visual and Mechanical Check
1. Verify that the installation matches the layout plan.2. The pipe connections, electrical cable connections and ancillary (from other trades) mounts and supports were properly installed.
3. The identification nameplates, pressure gauges and other identification tags were installed as required.
B. Utility Connections
1. Check to see if all utility services like water, steam, compressed air and nitrogen are connected.2. Check to see if the flow rates, pressure and temperature of the fluids are at acceptable levels for the equipment being tested.
C. Electrical Control System Testing
1. Each electrical control panel and PLC must function properly to allow both automatic and manual operations of the equipment.2. Perform a safety inspection on each sensor, alarm, and interlock; verify that they all function properly and will respond within the limits provided for equipment safety.
3. Ensure that the functions and automation of the equipment are performed in accordance with client's specifications (design).
D. Software and Data Integrity Verification
1. Audit trails and proper controls regarding access to the software and password must be validated for compliance.2. 21 CFR Part 11 and GAMP 5 requirements must be verified.
3. Ensure that the communication is valid between SCADA or MES and the equipment.
E. Functional and Performance Testing
1. Run the equipment with a normal load as the machine will operate in production.2. Record the important operating parameters such as speed, pressure, temperature and flow rate.
3. After completion of the functional and performance tests make comparisons with acceptance criteria.
F. Calibration and Documentation Review
1. Verify that all critical instruments have been properly calibrated.2. Review all instruments' certificates, the electrical (AC and DC) connection wiring diagrams and a list of all software backed up.
3. Verify that spare parts list and any maintenance information related to the equipment are available.
Roles and Responsibilities
Executing SAT successfully depends on multiple teams working together.Vendor responsible for preparation and implementation of SAT protocols, providing test equipment and trained personnel, providing assistance with troubleshooting if needed during testing and providing completed SAT report and supporting data to customers.
Customer Responsible for reviewing and signing off on SAT protocols before testing, observing tests and documenting their observations, making decisions regarding whether tests passed or failed based on acceptance criteria and providing acknowledgment that sat has been completed.
GMP and Regulatory Expectations
SAT has been emphasized by regulatory guidelines as a portion of Good Engineering Practice (GEP) as well as equipment qualification.EU GMP Annex 15 - Verifying equipment performance after installation must occur.
ISPE Baseline Guide - FAT & SAT are included in the commissioning and qualification life cycle for any systems.
GAMP 5 - Defines expectations for how computerized & automated systems are to be validated.
USFDA 21 CFR Part 211 - Properly installed, calibrated, and operated equipment is mandated by this regulation.
During GMP inspections, SAT results (and deviations) will be included in the qualification documentation reviewed.
Best Practices for SAT Execution
1. Create a detailed timeline for your SAT based on the requirements of your project.2. Use your approved FAT results to establish your SAT protocol.
3. Make sure that everything you measure is traceably calibrated using approved measuring devices.
4. Make a complete record of all existing utilities and environmental conditions at the jobsite.
5. Bring in Quality Assurance early in the process, their presence will give credibility to all of your data and ensure that your General Manufacturing Practice responsibilities are met.
6. Create photo, video or other documentary evidence of your validation process including test reports.
7. Attempt to resolve all deviation issues raised by qualification before moving forward with that qualification.
8. Archive and retain all SAT related documents securely for future audit purposes.
Benefits of Conducting SAT
1. SAT provides a way to verify that the equipment has been properly installed and integrated into the customer's environment.2. Identifies potential product defects at an early stage minimizing time spent waiting for qualification.
3. SAT also establishes a foundation of confidence in the equipment's reliability.
4. SAT provides the company with training opportunities for plant personnel who will operate and maintain the equipment.
5. Helps to prepare for inspections and compliance with all regulatory criteria.
SAT is an essential step in qualifying pharmaceutical equipment. With SAT, customers can verify that their installed system is capable of performing well under actual operating conditions while meeting both GMP and Safety regulations.
Through the verification of installation integrity, control system performance, and data integrity, SAT sets the stage for successful qualification and readiness for production.
Ultimately, a successful SAT will help ensure that quality, compliance, and performance are all built into the equipment before the production of any batches.
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