San Diego IQ OQ PQ Validation Services

For biopharmaceutical and medical related research manufacturers, quality control is one of the most important aspects to maintain safety and effectiveness of the products. Organizations of all sizes throughout San Diego have turned to GL Technologies for their quality control needs to implement a viable IQ OQ PQ validation process for their company. IQ OQ PQ validation is a systematic approach that validates and verifies equipment processes and systems used in the production of pharmaceuticals.

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What is IQ OQ PQ Validation?

While most quality control professionals at various biopharma research labs understand the importance of IQ OQ and PQ validation, there is often misconceptions about what these mean for an organizatino. The experts at GL Technologies have deep experience in implementing these validation processes for our clients. The variants between the 3:

IQ OQ PQ stands for
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

This validation is a 3-step process that provides the reassurance of the proper installation, functionality, and performance of equipment, processes, and systems.

What is Installation Qualification (IQ)

The first step in the process is IQ, installation qualification. IQ is a documentation and verification process that establishes that the equipment or system has been installed correctly and meets all required specifications.

During the IQ process, GL Technologies will perform the following activities:

Review Documents

Reviewing IQ documents involves comprehensive documentation to confirm adherence to regulatory requirements, manufacturer recommendations, and industry standards. This process includes examining installation protocols, equipment specifications, calibration records, and system drawings to verify proper installation and functionality.

Inspection and Verification

Inspection and verification procedures are conducted by GL Technologies to confirm that all components are in place, properly connected, calibrated, and functioning as intended. By assessing the installation process, IQ helps minimize risks associated with equipment malfunctions or deviations from regulatory standards, which creates a solid foundation for following validation activities and verifying the reliability and compliance of biopharmaceutical manufacturing operations.

Calibration and Testing

Calibration and testing are key components of the IQ process, with the goal to verify the accuracy and reliability of instruments and equipment used in various stages of biopharmaceutical manufacturing. Calibration includes adjusting instruments to meet predefined standards, while testing involves evaluating their functionality under simulated or actual operating conditions. By conducting calibration and testing procedures as part of IQ, biopharma companies can minimize risks and uphold the quality of their manufacturing processes, protecting both product quality and patient safety.

Documentation

Documentation plays a very important role in this process, providing a comprehensive record of the installation activities and verifying that all components are properly integrated and functioning as intended. Detailed documentation includes equipment specifications, installation procedures, calibration records, and any deviations found during the installation process. By documenting each step, IQ documentation not only establishes a baseline for future validation activities but also meets regulatory compliance and the integrity of the manufacturing process, protecting product quality and patient safety in the biopharmaceutical industry.

What is Operational Qualification (OQ)

The 2nd step in the process, verifying that the equipment operates within defined specifications. The OQ is part of the broader validation process, which also includes IQ and PQ. In the OQ phase, the equipment or system is tested to make sure that it functions properly under normal operating conditions. Includes verifying all components are installed correctly, that the system performs its intended functions, and meets the predefined acceptance criteria.

The OQ process involves creating a detailed protocol that outlines the specific tests and procedures that need to be and will be performed. These tests include: functionality testing, stress testing, performance testings, and environmental testing. It also specifies the acceptance critera that need to be met to demonstrate the equipment / system is operating within the needed parameters.

After the OQ tests have been conducted, the results are then documented in a report along with an deviations or issues found during the testing process. The report will serve as evidence that the equipment or system has been qualified and is suitable for its intended usage. It's an important step in providing reliability, quality, and compliance of systems and equipment in the heavily regulated biopharmaceutical industry.

What is Performance Qualification (PQ)

The 3rd and final step in the process, verifying that the equipment performs according to requirements and specifications. This phase of the validation process aims to demonstrate that the system and/or equipment consistently performs according to its intended use, under normal operating conditions.

During this phase, the equipment will be tested to make sure it meets the predefined acceptance criteria and is reliable, consistent, and accurate. The purpose is to verify that the equipment consistently produces the desired results and meets the established performance specs.

The PQ phase comes after the two earlier phases of validation (IQ and OQ). In the PQ phase, specific tests will be performed to evaluate the performance and functionality of the equipment. This involves simulating normal operating conditions, assessing the system's response to various inputs, evaluating accuracy and precision, and assessing the overall performance against predetermined criteria.

Again, the PQ activities and tests are documented in a PQ protocol which will outline the test procedures, acceptance criteria, and any other deviations or corrective actions. After the PQ testing is complete and the equipment / system meets the accepted criteria, it is considered qualified for its intended use.

Importance of IQ OQ PQ Validation

With any biopharmaceutical organization, to comply with regulatory standards your IQ OQ PQ validation is critical. These organizations need to stay compliant with the FDA's Current Good Manufacturing (cGMP) regulations. Failure to comply can damage an organization leading to product recalls, fines, and damage to their reputation.

When the right IQ OQ PQ validation process is implemented, this will help identify potential issues before they become bigger problems. The GL-Tec team will implement an IQ OQ PQ validation process for your organization that will identify and resolve potential issues before they impact the efficacy and safety of the products.

Key Articles

The Roadmap to Validation: IQ OQ PQ in Pharmaceutical Processes

In the regulated world of pharmaceuticals, maintaining the safety, potency, and quality of products is vital. To achieve this, pharmaceutical organizations rely on a validation process known as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This roadmap to validation is important for maintaining compliance with regulatory standards and delivering safe medications to patients worldwide.

Biopharma Metrology: The Key to Operational Quality (OQ)

In the biopharmaceutical and medical device industries, maintaining quality, safety, and efficacy of products is vital. The strict regulatory requirements and complex nature of these compounds demand precise and reliable measurements at every stage of production. This is where biopharma metrology plays a role, as the cornerstone of operational quality (OQ).

IQ OQ PQ Questions

What is the purpose of Installation Qualification (IQ)?

The purpose of Installation Qualification (IQ) is to verify and document that all components of a new system or equipment have been appropriately installed, calibrated, and configured according to predefined specifications and requirements. This initial phase of the validation process makes sure that the installation is in accordance with the manufacturer's guidelines, regulatory standards, and any specific operational or safety requirements.

What does Operational Qualification (OQ) involve?

OQ focuses on verifying and assuring that the equipment or system performs consistently within its operational limits and specifications. It involves a series of documented tests and procedures that validate the functionality of the equipment, verifying it operates accurately and reliably under normal working conditions.

Why is Performance Qualification (PQ) important in validation?

By conducting PQ, organizations validate the reliability, repeatability, and robustness of the system or process, validating its capability to consistently deliver the intended results, comply with regulatory standards, maintain product quality, and protect consumer safety.

What documentation is required for IQ, OQ, and PQ processes?

Documentation includes a calibration plan which outlines the specific calibration procedures and parameters to be followed. A detailed instrument qualification report is necessary to document the qualification process and confirm that the HPLC system meets predefined acceptance criteria. The calibration log needs to be filled out during the calibration process including that has the date, time, and results of each calibrated standard or reference materials used is important to validate their authenticity. Finally, any deviation or incidents encountered during the calibration process need to be recorded in an incident report which provides an account of the issue and any corrective actions taken. Together, these documents verify the accuracy and reliability of HPLC calibration and provide a full record for future reference and quality assurance.

What is Operational Qualification (OQ), and what does it involve?

Operational Qualification (OQ) is an important phase in the validation process of equipment, systems, instruments, or processes in the bio-pharmaceutical and manufacturing industries. It involves a series of documented tests designed to verify that the equipment or system operates according to its intended functions with predetermined operational parameters. OQ includes activities including performance testing, calibration verification, functionality testing, and a documentation review to make sure that the equipment or system meets the predefined specs and regulatory requirements. By conducting OQ, companies can establish confidence in the reliability and consistency of their operational processes which maintains product quality and safety.

Are there any specific regulations or guidelines that outline the requirements for IQ, OQ, and PQ?

Yes. There are regulations and guidelines that outline the requirements for IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). These qualifications are used in the pharmaceutical industry and manufacturing where equipment systems and processes need to be validated so they meet predefined standards and perform consistently. Regulatory entities like the FDA and ISO provide comprehensive guidance on IQ, OQ, and PQ requirements where the guidelines define the scop and objectives of each qualification, provide instructions for test protocols, acceptance criteria, and documentation.

Why are IQ, OQ, and PQ important in regulated industries such as pharmaceuticals?

IQ, OQ, PQ play an important role in the pharmaceutical industry because they verify the quality, reliability, and compliance of critical equipment and processes. IQ validates that the equipment is installed correctly and meets required specifications including appropriate utilities and documentation. OQ verifies that the equipment is operating as intended and performs within predefined parameters to maintain functionality and accuracy. PQ is the final phase, it includes demonstrating that the equipment consistently produces desired results and meets the acceptance criteria. By implementing these qualification phases, pharmaceutical companies can maintain the integrity of their operations and minimize risks which verifies the safety of pharmaceutical products.

How often should IQ, OQ, and PQ be performed?

The frequency of conducting IQ OQ PQ largely depends on several factors including the type of equipment, its criticality to operations, regulatory requirements, and any modifications made. Regular review and adherence to established guidelines are crucial in determining the appropriate timing for conducting IQ, OQ, and PQ.

How does OQ affect the overall reliability and accuracy of HPLC results?

OQ (Operational Qualification), has an important role in determining the overall reliability and accuracy of HPLC results. OQ involves the verification and documentation that the HPLC system meets predetermined specifications and performs consistently within acceptable limits. Conducting a thorough OQ, sources of error or deviations in the HPLC system can be identified and fixed quickly to maintain accurate results. OQ involves evaluating parameters including column performance system suitability, detector response, injection precision, and calibration accuracy. It also establishes the systems baseline performance and identifies any deviations so correct measures can be taken.

Are IQ, OQ, and PQ required for all equipment and instruments?

IQ, OQ, PQ qualifications are validation processes commonly used in the pharmaceutical industry. While these procedures are not universally mandatory for all equipment and instruments, they are required for critical or high-risk equipment. The purpose of IQ is to make sure that the equipment is installed correctly, OQ tests that it functions properly, and PQ validates its performance under normal operations conditions. The qualifications need depend on a few factors including the nature of the equipment, its impact on product quality, and regulatory requirements. It’s important for organizations to evaluate the criticality of their equipment to determine the level of qualification needed for compliance and quality assurance.

GL Technologies and IQ OQ PQ

The team at GL Technologies understands the importance of IQ OQ PQ validation in the biopharmaceutical and related industries. We take a comprehensive approach so your organization has full compliance with regulatory requirements and industry standards.

With over 2 decades experience implementing in IQ OQ PQ validation services, we follow a rigorous validation process which includes risk assessments, protocol development, testing, and documentation. Our comprehensive approach to IQ OQ PQ validation, will provide your organization peace of mind that compliance with regulatory requirements and industry standards is maintained.