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.

To speak with the experts about your IQ OQ PQ needs, please fill out our online form or give us a call!

858-202-1408

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).

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.