In the pharmaceutical industry, the equipment and automated systems must be tested for reliability before being installed into a manufacturing facility. One of the most common methods of testing for reliability is through a Factory Acceptance Test (FAT). The FAT is a critical test for validating equipment and automated systems to ensure that the performance, compliance and quality of equipment is achieved before being shipped to site.
When performed properly, FAT provides the opportunity to identify design errors, functional deficiencies and compliance issues early on. This will allow time and cost savings while performing commissioning and qualification. This post will cover the details of FAT including its objectives, its scope of activities, the protocol requirements for conducting FAT, what documentation is required and best practices for performing FAT.
FAT provides an opportunity to verify that the mechanical systems, electrical systems, automation systems, and software systems are operating according to approved design documents. FAT also serves as a means of establishing a connection between manufacturing and site installation.
Generally, a representative from the end user (pharmaceutical company), a representative from the supplier and possibly a third-party validation or quality assurance consultant will observe the FAT.
1. To confirm the design and operational characteristics of the equipment by verifying that they meet the specified design, functional and safety criteria.
2. To detect, address and resolve all problems before shipment so that the amount of on-site re-configuration required is minimized.
3. To verify that the system is compliant with Good Manufacturing Practices (GMP), GAMP and other regulatory standards.
4. To provide an opportunity for operator, engineer, and quality assurance staff to become familiar with the operational characteristics of the equipment.
5. To review the documentation associated with the FAT by verifying the accuracy and completeness of drawings, calibration certificates, software documentation and operating manuals.
A successful FAT will minimize the risk of delay due to Site Acceptance Testing (SAT) or Installation Qualification (IQ) because there is minimal need for either process to occur in order to pass the FAT.
The factory acceptance test protocol should contain the following parts:
1. Purpose and Scope: It defines the equipment or system that is going to be tested and the objectives of the factory acceptance test.
2. Responsibilities: It defines the roles of the manufacturer, client and validation personnel.
3. Equipment Description: It contains the model number, serial number, capacity and other major specifications of the equipment.
4. Reference Documents: It contains the user requirements specification (URS), design specification (DS), piping and instrumentation diagram (P&ID), wiring diagrams and functional specification (FS) of the equipment.
5. Test Procedures: It describes how to conduct a step-by-step mechanical, electrical, software and functional verification.
6. Acceptance Criteria: The Factory Acceptance Test Protocol will list measurable acceptance criteria (e.g., flow rates, ranges of measured temperatures, the control’s response to varying temperature, the response to input command).
7. Deviations and Corrective Actions: Procedures to address the corrective actions required if the tests fail or do not meet acceptance criteria.
8. Documentation of Findings/Sign-off: All test results will be reflected on the FAT report; the FAT report will serve as documentation to support qualification at the customer's site.
2. Check the surface finish, quality of the welding, the certificate of the materials and the nameplate labels.
3. Check that the accessories and spare parts are complete and available.
2. Check that the motors, sensors, alarms and interlocks are functioning appropriately as required.
3. Check that temperature sensors, pressure gauges and flow meters are calibrated and working as per requirement.
2. Check that the human machine interface (HMI) and programmable logic controller (PLC) are working as designed.
3. Check that the software is compliant with guidelines defined in GAMP 5 for computerized systems.
4. Check that data logging and audit trail functions are present where applicable as per 21 CFR Part 11 compliance requirements.
2. Check that operating parameters meet acceptance criteria such as quantity of flow, temperature uniformity and mixing efficiency.
3. Check that all equipment are functioning as required.
2. Check that the safety devices respond appropriately to electrical faults and power outages.
2. Check that all critical documentation associated with the equipment is complete before it is shipped.
Manufacturers are responsible for preparing the FAT protocol and testing environment, conducting all checks before FAT to ensure the manufacturer and tester are ready, providing instruments used in tests and calibrated devices and recording results and any deviations.
Customers are responsible for reviewing and approving the FAT protocol, witnessing all tests and making observations, reviewing the documentation and approving results and signing the FAT report when all steps have been completed satisfactorily.
1. DQ or Design Qualification validates that the design of a piece of equipment meets the needs and expectations of the end-user.
2. FAT or Factory Acceptance Testing is performed to verify that the equipment is functioning correctly according to the manufacturer's specifications and in a manner consistent with what has been detailed in the FAT.
3. IQ or Installation Qualification verifies that the equipment was installed properly according to the manufacturer's specifications.
4. OQ or Operational Qualification verifies that the equipment is functioning as intended during normal operating conditions.
5. PQ or Performance Qualification verifies that the equipment performs consistently in actual production. Having a documented FAT is a good practice because it provides the necessary documentation for smoother equipment qualification at future stages and reduces the risk of costly downtime due to errors in previous stages.
FAT documentation must be used as part of the qualifications during a GMP inspection, as it is considered an acceptable method to verify that a system has been designed correctly before it is installed. Poor or incomplete FAT documentation may result in findings during GMP inspections that may lead to compliance risk.
1. Prepare in Advance - All requirements for FAT should be included in the URS.
2. Engage All Team Members - The FAT planning process should include the participation of QA, engineering, and validation personnel.
3. Recreate Typical on-Site Conditions - All efforts for training and testing must be performed using utilities that closely represent actual on-site conditions.
4. Use Calibrated Instruments - All instruments used for measuring will have current calibration certificates.
5. Record Everything - Complete records must be maintained and include photographs, videos, and signatures from those involved.
6. Manage Deviations - Any deviation from the procedures used during FAT must be documented and identified prior to shipment.
7. Train Operators Using FAT - The FAT will provide an opportunity to train potential operators on the given equipment before actual operation.
8. Conclude FAT Report - In addition to recording the results of the FAT, the report will provide a summary of any deviations and corrective measures for future reference.
2. Reduced costs associated with costly rework and increased project delays due to equipment-related issues.
3. Increased client confidence in the quality of the equipment being manufactured and the capabilities of the vendor.
4. Ensured compliance with GMP and other applicable regulations.
5. Easier and faster commissioning, qualification and production ramp-up for the customer.
The Factory Acceptance Test (FAT) is much more than just a formality because it plays a critical role in the qualification of pharmaceutical equipment as a quality assurance step as it relates to the qualification of pharmaceutical equipment.
By completing a FAT in a systematic manner and documenting the results of each test, pharmaceutical companies can ensure that their equipment meets the required performance criteria, is compliant with regulatory agencies like FDA and will not experience any issues or delays during installation or validation.
In this highly regulated and competitive industry, a well-planned FAT can not only save pharmaceutical companies valuable time and money but will also instill confidence in all persons involved regarding the quality and reliability of their manufacturing systems.
When performed properly, FAT provides the opportunity to identify design errors, functional deficiencies and compliance issues early on. This will allow time and cost savings while performing commissioning and qualification. This post will cover the details of FAT including its objectives, its scope of activities, the protocol requirements for conducting FAT, what documentation is required and best practices for performing FAT.
What is a Factory Acceptance Test (FAT)?
The Factory Acceptance Test (FAT) is a formal testing and evaluation of all equipment and systems at the manufacturer's facility before its shipping to the pharmaceutical company. The purpose of FAT is to ensure that all equipment is in compliance with User Requirement Specifications (URS), Design Specifications (DS) and Good Manufacturing Practices (GMP).FAT provides an opportunity to verify that the mechanical systems, electrical systems, automation systems, and software systems are operating according to approved design documents. FAT also serves as a means of establishing a connection between manufacturing and site installation.
Generally, a representative from the end user (pharmaceutical company), a representative from the supplier and possibly a third-party validation or quality assurance consultant will observe the FAT.
Objectives of FAT
In the pharmaceutical industry, the principal objectives of FAT are as follows:1. To confirm the design and operational characteristics of the equipment by verifying that they meet the specified design, functional and safety criteria.
2. To detect, address and resolve all problems before shipment so that the amount of on-site re-configuration required is minimized.
3. To verify that the system is compliant with Good Manufacturing Practices (GMP), GAMP and other regulatory standards.
4. To provide an opportunity for operator, engineer, and quality assurance staff to become familiar with the operational characteristics of the equipment.
5. To review the documentation associated with the FAT by verifying the accuracy and completeness of drawings, calibration certificates, software documentation and operating manuals.
A successful FAT will minimize the risk of delay due to Site Acceptance Testing (SAT) or Installation Qualification (IQ) because there is minimal need for either process to occur in order to pass the FAT.
Scope of FAT
Typically, FAT includes the following elements to ensure that:- Mechanical and electrical integrity
- Functional control and automation
- Alarm testing for the software
- Emergency/safety interlocks
- Calibration and verification for instrumentation
- System recovery (power failure) and restart
- Design document and certificate review
- Bill of materials/spare parts verification
Protocol and FAT Documentation
In order for a manufacturer and the client's Quality Assurance department approval of the factory acceptance test you need to create a factory acceptance test protocol before performing a factory acceptance test.The factory acceptance test protocol should contain the following parts:
1. Purpose and Scope: It defines the equipment or system that is going to be tested and the objectives of the factory acceptance test.
2. Responsibilities: It defines the roles of the manufacturer, client and validation personnel.
3. Equipment Description: It contains the model number, serial number, capacity and other major specifications of the equipment.
4. Reference Documents: It contains the user requirements specification (URS), design specification (DS), piping and instrumentation diagram (P&ID), wiring diagrams and functional specification (FS) of the equipment.
5. Test Procedures: It describes how to conduct a step-by-step mechanical, electrical, software and functional verification.
6. Acceptance Criteria: The Factory Acceptance Test Protocol will list measurable acceptance criteria (e.g., flow rates, ranges of measured temperatures, the control’s response to varying temperature, the response to input command).
7. Deviations and Corrective Actions: Procedures to address the corrective actions required if the tests fail or do not meet acceptance criteria.
8. Documentation of Findings/Sign-off: All test results will be reflected on the FAT report; the FAT report will serve as documentation to support qualification at the customer's site.
Factory Acceptance Test Activities
There are many differences between factory acceptance tests based on the equipment being tested, but some activities are similar between all factory acceptance tests.A. Visual and Mechanical Evaluation
1. Check that the parts and assemblies conform with drawings that received approval.2. Check the surface finish, quality of the welding, the certificate of the materials and the nameplate labels.
3. Check that the accessories and spare parts are complete and available.
B. Validation Electrical and Instrumentation
1. Check the wiring and terminal connections according to the equipment drawings.2. Check that the motors, sensors, alarms and interlocks are functioning appropriately as required.
3. Check that temperature sensors, pressure gauges and flow meters are calibrated and working as per requirement.
C. Validation of Software and Automation
1. Check that the control logic and interlocks are functioning and alarms operate as designed.2. Check that the human machine interface (HMI) and programmable logic controller (PLC) are working as designed.
3. Check that the software is compliant with guidelines defined in GAMP 5 for computerized systems.
4. Check that data logging and audit trail functions are present where applicable as per 21 CFR Part 11 compliance requirements.
D. Validation of Functional and Performance
1. Simulate water and air operating conditions as they would occur in real operation.2. Check that operating parameters meet acceptance criteria such as quantity of flow, temperature uniformity and mixing efficiency.
3. Check that all equipment are functioning as required.
E. Validation of Safety and Emergency
1. Check that safety devices such as emergency stop buttons, interlocks and pressure devices are operating as designed.2. Check that the safety devices respond appropriately to electrical faults and power outages.
F. Review of Documentation
1. Review user manuals of equipment, schematic drawings, calibration reports, software version history and preventive maintenance schedule.2. Check that all critical documentation associated with the equipment is complete before it is shipped.
Roles and Responsibilities During FAT
The Customer and Manufacturer share major responsibilities in the execution of FAT.Manufacturers are responsible for preparing the FAT protocol and testing environment, conducting all checks before FAT to ensure the manufacturer and tester are ready, providing instruments used in tests and calibrated devices and recording results and any deviations.
Customers are responsible for reviewing and approving the FAT protocol, witnessing all tests and making observations, reviewing the documentation and approving results and signing the FAT report when all steps have been completed satisfactorily.
Role of FAT in Qualification Lifecycle
The FAT is part of the equipment qualification lifecycle. As previously described, the equipment qualification lifecycle consists of the following steps:1. DQ or Design Qualification validates that the design of a piece of equipment meets the needs and expectations of the end-user.
2. FAT or Factory Acceptance Testing is performed to verify that the equipment is functioning correctly according to the manufacturer's specifications and in a manner consistent with what has been detailed in the FAT.
3. IQ or Installation Qualification verifies that the equipment was installed properly according to the manufacturer's specifications.
4. OQ or Operational Qualification verifies that the equipment is functioning as intended during normal operating conditions.
5. PQ or Performance Qualification verifies that the equipment performs consistently in actual production. Having a documented FAT is a good practice because it provides the necessary documentation for smoother equipment qualification at future stages and reduces the risk of costly downtime due to errors in previous stages.
GMP and Regulatory Expectations
Regulatory bodies like USFDA, EMA and WHO consider factory acceptance testing (FAT) a component of good engineering and validation practices.FAT documentation must be used as part of the qualifications during a GMP inspection, as it is considered an acceptable method to verify that a system has been designed correctly before it is installed. Poor or incomplete FAT documentation may result in findings during GMP inspections that may lead to compliance risk.
Best Practices for FAT Execution
There are several important steps to take to perform a successful FAT:1. Prepare in Advance - All requirements for FAT should be included in the URS.
2. Engage All Team Members - The FAT planning process should include the participation of QA, engineering, and validation personnel.
3. Recreate Typical on-Site Conditions - All efforts for training and testing must be performed using utilities that closely represent actual on-site conditions.
4. Use Calibrated Instruments - All instruments used for measuring will have current calibration certificates.
5. Record Everything - Complete records must be maintained and include photographs, videos, and signatures from those involved.
6. Manage Deviations - Any deviation from the procedures used during FAT must be documented and identified prior to shipment.
7. Train Operators Using FAT - The FAT will provide an opportunity to train potential operators on the given equipment before actual operation.
8. Conclude FAT Report - In addition to recording the results of the FAT, the report will provide a summary of any deviations and corrective measures for future reference.
Benefits of an Effective FAT
1. Reduced risk of failure at facility installations.2. Reduced costs associated with costly rework and increased project delays due to equipment-related issues.
3. Increased client confidence in the quality of the equipment being manufactured and the capabilities of the vendor.
4. Ensured compliance with GMP and other applicable regulations.
5. Easier and faster commissioning, qualification and production ramp-up for the customer.
The Factory Acceptance Test (FAT) is much more than just a formality because it plays a critical role in the qualification of pharmaceutical equipment as a quality assurance step as it relates to the qualification of pharmaceutical equipment.
By completing a FAT in a systematic manner and documenting the results of each test, pharmaceutical companies can ensure that their equipment meets the required performance criteria, is compliant with regulatory agencies like FDA and will not experience any issues or delays during installation or validation.
In this highly regulated and competitive industry, a well-planned FAT can not only save pharmaceutical companies valuable time and money but will also instill confidence in all persons involved regarding the quality and reliability of their manufacturing systems.
Get ready to use editable Validation Protocols in MS-Word FormatView List
No comments:
Post a Comment
Please don't spam. Comments having links would not be published.