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Orange County IQ OQ PQ Validation

Maintaining product quality, safety, and compliance with regulatory standards is absolutely vital for biopharma and pharmaceutical organizations. One critical aspect of achieving these goals is through validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These protocols, referred to as IQ OQ PQ validation, serve as a systematic approach to verify and document that equipment, systems, and processes are suitable for their intended use. The team at GL Technologies has extensive experience in helping Orange County biopharma and related industries with IQ OQ PQ validation services.  

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?


Installation Qualification (IQ)


IQ is the first step in the validation process and involves verifying that equipment and systems are correctly installed according to manufacturer specifications and industry guidelines. The GL Technologies process for IQ includes checking components, utilities, and documentation to verify that everything is in place before the equipment is used in production.

Operational Qualification (OQ)


During the OQ phase, the GL Technologies team makes sure that equipment operates as intended throughout its operational range. This involves testing various parameters including temperature, pressure, speed, and functionality, to validate consistent performance under different conditions. OQ also includes verifying that alarms, safety features, and control systems function correctly.

Performance Qualification (PQ)


PQ is the final stage of our validation process and involves demonstrating that the equipment or process consistently produces results within predetermined specifications. This involves conducting tests using actual production materials or simulated conditions to evaluate performance under normal operating conditions.

Importance of IQ OQ PQ Validation in Biopharma


Regulatory Compliance


Regulatory agencies including the FDA and EMA require biopharmaceutical and pharmaceutical companies to maintain strict validation standards for product quality and potency. IQ OQ PQ validation helps companies demonstrate compliance with regulatory requirements and standards such as GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufacturing Practice).

Risk Mitigation


Validation helps identify and minimize risks associated with equipment, processes, and systems that could impact product quality or patient safety. By testing and documenting each stage of the validation process, biopharma organizations can minimize the risk of errors and product failures.

Quality Assurance


IQ OQ PQ validation plays an important role in maintaining product quality and consistency throughout the manufacturing process. By establishing validated processes and equipment, companies can reduce variability and uphold quality standards across batches.

Choosing GL Technologies for IQ OQ PQ Services


Given the complexity and critical nature of IQ OQ PQ validation in the biopharma industry, many companies throughout Orange County work with the team at GL Technologies.  When selecting a validation company, consider the following factors:

Experience and Expertise


The team at GL Technologies has extensive experience biopharmaceutical validation. We maintain a track record of successfully completed projects and a team of qualified validation professionals familiar with industry regulations and best practices.

Comprehensive Services


GL Technologies offers a comprehensive range of services tailored to the specific needs of biopharma companies, including IQ OQ PQ validation, protocol development, risk assessment, and documentation support.

Compliance and Certification


We always operate in compliance with regulatory requirements and holds certifications such as ISO 9001 and ISO 17025. This demonstrates a commitment to quality and adherence to industry standards.

Flexibility and Support


When your organization works with GL Technologies, we adapt to your company's unique requirements and provide ongoing support throughout the validation process and beyond. Effective communication, responsiveness, and collaboration are important to us for a successful partnership.

Key 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.

GL Technologies Overview


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, Long Beach, and Irvine.

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

REQUEST A QUOTE

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

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