Service/Sales/ General Inquiries 858-202-1408

La Jolla IQ OQ PQ Services

For biopharma and pharmaceuticals companies throughout La Jolla, validating product quality, safety, and compliance with regulatory standards is vital. This is where IQ, OQ, and PQ come into play, forming the cornerstone of validation processes within the industry. The team of experts at GL Technologies is well-versed and trained in IQ OQ PQ validation services working with numerous clients in the La Jolla region.  

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


Understanding IQ, OQ, PQ

Installation Qualification (IQ)

Installation Qualification (IQ) is the initial phase of equipment validation, verifying that all components of the equipment are delivered as designed and specified. During IQ, equipment is installed according to manufacturer specifications and in accordance with regulatory requirements. This includes verifying documentation including manuals, certificates, and calibration records. The goal is to establish confidence that the equipment is capable of consistently performing within the defined operational parameters.

Operational Qualification (OQ)

Operational Qualification (OQ) focuses on verifying that the equipment operates as intended throughout its entire operating range. This involves testing the equipment under various conditions to make sure that it consistently produces results within predetermined specifications. OQ tests may include functionality checks, performance verification, and calibration verification. By conducting OQ, pharmaceutical manufacturers can identify and fix any deviations in equipment performance before proceeding to the next stage.

Performance Qualification (PQ)

Performance Qualification (PQ) is the final stage of equipment validation, where it is tested under simulated or actual operating conditions to demonstrate its ability to consistently produce products of the desired quality. PQ evaluates the equipment’s performance in relation to the critical process parameters and quality attributes specified for the product. This involves running production batches and conducting testing to verify that the equipment meets predefined acceptance criteria. Successful completion of PQ provides assurance that the equipment, when used in its intended environment, consistently produces results within established specifications.

Importance of IQ, OQ, PQ in Pharmaceutical

Regulatory Compliance

IQ, OQ, PQ are vital elements of regulatory compliance in the pharmaceutical industry. Regulatory agencies including the FDA and EMA require validation of equipment and processes to validate product quality, safety, and potency. Adhering to IQ, OQ, PQ guidelines demonstrates a commitment to quality assurance and regulatory compliance.

Risk Mitigation

Validation through IQ, OQ, PQ helps identify and minimize risks associated with equipment malfunctions or deviations in performance. By systematically validating equipment, pharmaceutical manufacturers can minimize the likelihood of product quality issues, batch failures, and regulatory non-compliance.

Quality Assurance

IQ, OQ, PQ play an important role in maintaining product quality and consistency. By validating equipment and processes, manufacturers can establish confidence in the reliability and reproducibility of their manufacturing operations. This leads to the production of high-quality pharmaceutical products that meet regulatory requirements and customer expectations.

Cost Savings

Investing in IQ, OQ, PQ upfront can result in long-term cost savings by preventing costly rework, production delays, and regulatory setbacks. By validating equipment and processes before full-scale production, manufacturers can identify and address potential issues early in the development process, saving both time and resources.

IQ OQ PQ Resources

IQ OQ PQ: Building Blocks of Biopharmaceutical Manufacturing

In the complex and strictly regulated world of biopharmaceutical manufacturing, verifying the safety and quality of products is of utmost importance. To achieve this, the biopharma industry relies on a systematic approach known as IQ, OQ, PQ. These acronyms stand for Installation Qualification (IQ), Operational Qualification (OQ, and Performance Qualification (PQ). Together, they form the cornerstone of building a successful and compliant manufacturing process. Let’s discuss the significance of of IQ OQ PQ and how they contribute to the production of life-saving medications.

Improve HPLC Performance Through Operational Qualification

HPLC (high-performance liquid chromatography) is a widely used analytical technique in the pharmaceutical and biopharmaceutical industries. HPLC provides researchers and analysts with reliable and quantitative data about the composition of complex mixtures. To verify accurate and reproducible results, it’s important to maintain and optimize the performance of the HPLC system. A vital step in this process is OQ (operational qualification). OQ can improve the performance of an HPLC system for organizations in a variety of ways.

About GL Technologies

GL Technologies
(formally Calibration Consultants) is a full service calibration provider specializing in the Biopharmaceutical and Medical Device industries. Our management has worked in, managed, and developed FDA cGMP fully compliant programs. Our services include roving crews for the Biopharmaceuticals for regular scheduled calibrations or shutdown and new system situations. GL Technologies also provides IQ PQ OQ services to clients throughout San DiegoSan Francisco, and Los Angeles. While also specializing in HPLC repar and calibration and mass spectrometry calibration. We also serve La Jolla companies with HPLC repair.

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



To request a quote from GL-Tec, please fill out our online form and we will get back to you promptly.


GL Technologies Location