IQ OQ PQ Validation: Quality and Compliance for Your Business
When it comes to quality assurance testing for the manufacturing process, GL Technologies helps biopharmaceutical and medical related companies throughout the Los Angeles region with their IQ OQ PQ requirements and validations. For manufacturers, to meet industry regulations it requires rigorous testing and verification that is vital for research and production in these industries. GL Technologies provides comprehensive IQ OQ PQ programs to help organizations of all sizes verify their equipment and processes are functioning as required. We have worked hard to earn the trust of the Los Angeles business community for providing IQ OQ PQ services.
To speak with the experts about your OQ IQ PQ needs, please fill out our online form or give us a call!
What is OQ IQ PQ Validation?
The expert team at GL Technologies provides a comprehensive approach to your equipment and systems so they are installed and operated propertly to meet industry standards and regulatory requirements.
Installation Qualification (IQ)
Phase 1 of the validation process is the Installation Qualification (IQ) phase which includes the installation of a particular component or system is carried out and implemented correctly and in accordance with predefined specifications. The IQ phase focuses on verification of the equipment or systems that they are properly installed, positioned, and connected to the necessary utilities including power, water, or gas. During this phase, a detailed document is prepared to record the installation activities which includes equipment specifications, serial numbers, and the installation procedure. This document will serve as evidence that installation has been completed per defined requirements and has a solid foundation for future qualification activities.
The goal of IQ is to establish confidence that the installed equipment or system meets the standards and specifications for its intended use; it involves a series of activities and tests such as visual inspection, functional tests, and document verification. The visual inspection make sure that all equipment is in good condition and properly labeled, a functional test is conducted to verify the equipment will operate as intended and meet performance specifications, and the document verification involves reviewing and checking installation protocols, user manuals, certificates of calibration, and any relevant documents to maintain and show compliance.
Operational Qualification (OQ)
The second phase in the validation process is Operational Qualification (OQ) that aims to verify the validated system operates consistently within specified operational limits and performance requirements. OQ involves the predefined tests and procedures to verify that the euqipment functions as intended and needed while meeting all predfined acceptance criteria.
GL Technologies will perform a series of tests during the OQ phase to test the systems functionality and performance. Includes: operational parameters, verifying accuracy of sensors and instruments, testing the system's response to operational variations, and evaluating the system performance under normal and worst-case scenarios. The protocols and acceptance critera are predefined based on regulatory guidelines and specific user requirements. When the OQ phase is successful, it will show that the system is ready for the next stage in the validation process, the performance qualificaiton (PQ) phase.
Performance Qualification (PQ)
Probably the most important phase out of the 3 is the Performance Qualification (PQ) phase. This phase is designed to make sure that the equipment or system performs consistently within specified parameters and meets the needed regulatory standards. During this phase, the equipment will be tested under normal operating conditions to verify it's performance and ability to prodcue reliable and accurate results. This phase involves establishing acceptance critera, conducting tests, and analyzing data so the equipment and systems meet predefined performance requirements. It is the final step in the validation process to provide that the equipment is ready for its intended purpose and can deliver results.
The goals of the PQ phase are multi-faceted, to begin, it aims to verify the equipment or system is operating consistently and accurately, producing results thare meet the predefined specifications and regulations. When we subject the equipment to rigorous testing & analysis, PQ will help to identify any potential deviations that may arise during normal operation. It also provides teh ability to validate the equipment's performance across a range of operating conditions. Ultimately, it serves as a means to establish and document evidence of compliance with regulatory standards, giving regulatory bodies and key stakeholders the peace of mind that the system is qualified and can be used with confidence.
IQ OQ PQ Benefits
Equipment and Processes Meet Standards
IQ, OQ, and PQ combined help to verify that equipment, systems, and processes meet the predetermined quality and regulatory standards. This gives peace of mind that the equipment is installed correctly, works as intended, and delivers consistent performance results.
Product Quality and Safety
When organizations conduct IQ OQ PQ validations they are able to identify and fix any potential issues or deviations in the equipment and processes before they impact product quality and safety. This will minimize the risk of product defects and reduces non-compliance issues.
Demonstrates Regulatory Compliance
Through the IQ OQ PQ validation process, it adheres to regulatory requirements that your manufacturing process is in compliance, with documented evidence of validation to demonstrate your organization's commitment to your processes.
Facilitates Troubleshooting and Maintenance
The validation process establishes baseline performance criteria and identifies important parameters. This information becomes valuable during troubleshooting and maintenance activities. If deviations should occur, the established baseline and parameters aid in diagnosing problems, leading to quicker resolutions.
About GL Technologies IQ QO PQ
With extensive experience and implementation of IQ OQ PQ validation processes, the professional team at GL Technologies can help your biopharmaceutical implement IQ OQ PQ services to remain compliant with federal regulatory agencies and maintain your products quality during the manufacturing process. We work with biopharmaceutical organizations both large and small throughout Los Angeles and the greater state of California.
To speak with the experts about your OQ IQ PQ needs, please fill out our online form or give us a call!