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Irvine IQ OQ PQ Services

 The team at GL Technologies has decades of experience working with biopharmaceutical and pharmaceutical organizations throughout Irvine and the Orange County area. IQ OQ PQ validation plays an important role in manufacturing processes to maintain the integrity and potency of biopharma manufacturing processes. Organizations hroughout Irvine rely on the GL Technologies team for their IQ OQ PQ requirements and needs.

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


Key Phases for IQ OQ PQ

Installation Qualification (IQ)

Installation Qualification (IQ) for Biopharma includes a process making sure that the installation of equipment, systems, and facilities within a biopharmaceutical setting meets predefined specifications and regulatory requirements. During this phase, GL Technologies confirms that each component is correctly installed, calibrated, and connected according to the manufacturer's guidelines and industry standards. With a focus on validating the infrastructure's integrity and functionality, IQ establishes a solid foundation for the following qualification stages, maintaining product quality, compliance, and patient safety throughout the biopharmaceutical manufacturing process.

Operational Qualification (OQ)

Operational Qualification (OQ) for biopharmaceutical and pharmaceutical manufacturing involves the testing and documentation of equipment and processes to verify that they consistently perform within predetermined specifications. In the biopharmaceutical industry, OQ plays an important role in verifying that manufacturing systems, such as bioreactors, chromatography systems, and sterilization equipment, operate effectively and reliably. This validation process includes various parameters such as temperature, pressure, flow rates, and sterilization cycles, meeting compliance standards with regulatory requirements and adherence to Good Manufacturing Practices (GMP). By conducting OQ, biopharmaceutical organizations can maintain the integrity and quality of their products for both patient safety and meeting industry standards.

Performance Qualification (PQ)

The final state, following Installation Qualification (IQ) and Operational Qualification (OQ), focuses on verifying that the equipment or system functions reliably in its intended environment, meeting predefined acceptance criteria. PQ tests are designed and executed to test the system's performance under simulated real-world conditions, including various stress tests, worst-case scenarios, and operational limits. For the biopharmaceutical industry, PQ is particularly vital as it verifies the reliability and consistency of manufacturing processes, protecting product quality, potency, and patient safety.

Trending IQ OQ PQ Articles

Quality and Compliance: HPLC OQ in the Biopharmaceutical Industry

The biopharmaceutical industry plays an important role in developing and producing life-saving drugs and therapies. Maintaining the quality and safety of these products is of utmost importance. HPLC (high-performance liquid chromatography) is a widely used analytical technique in the biopharma industry for assessing the quality and purity of drugs and biologics. To meet regulatory standards for quality, organizations perform HPLC Operational Qualification (OQ). Let’s jump into the significance of HPLC OQ in the biopharma industry, its processes, and the role it plays in meeting compliance and product integrity.

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.

Why Do Companies Require IQ OQ PQ Validation?

Pharmaceutical manufacturing relies on IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation to maintain the quality and potency of produced medicines. IQ validates the proper installation of equipment and systems, OQ verifies their operational parameters are within specified limits, and PQ confirms consistent performance under actual production conditions. This strictvalidation process guarantees compliance with regulatory requirements, such as Good Manufacturing Practices (GMP), minimizes risks of product defects or contamination, and maintains the integrity of pharmaceutical products throughout their lifecycle, protecting public health.

GL Technologies

As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. We serve all of Orange County with IQ OQ PQ services including Anaheim and Long Beach.  We also provide fume hood certification services for clients and HPLC calibration and repair and building maintenance systems.

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



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