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Anaheim IQ OQ PQ Validation

For biopharmaceutical manufacturing, maintaining product quality, safety, and compliance with regulatory standards is vital. To achieve this, biopharma and pharmaceutical organizations throughout Anaheim rely on the team at GL Technolgoes for validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). With a team of highly qualified professionals, GL Technologies provides IQ OQ PQ services for our clients throughout the entire Anaheim and Orange Couny region.

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

IQ: Installation Qualification


Installation Qualification (IQ) is the 1st step in the validation process and focuses on verifying that equipment and systems are properly installed according to manufacturer specifications and regulatory requirements. In the biopharmaceutical and medical equipment industries, where precision and accuracy are of the utmost importance, IQ plays a role in verifying that equipment is installed correctly and capable of delivering the intended results.

Key Aspects of IQ


Verification of Installation


A key aspect of IQ involves the verification of installation processes. This process makes sure that all components of a system or equipment are installed correctly and according to specifications. Verification checks may involve examining the physical placement of components, confirming proper connections, and evaluating any necessary adjustments or calibrations. By verifying installation, potential issues or errors can be identified and fixed early on, minimizing the risk of operational problems and maintaining peak performance and safety.

Documentation and Records


Installation Qualification documentation plays a role in maintaining the integrity and compliance of equipment and systems. IQ serves as the foundation for validating the proper installation of equipment, confirming that it meets predefined specifications and regulatory requirements. This comprehensive documentation details the installation process, including equipment specifications, calibration records, and verification of proper functioning. By documenting the installation process, biopharmaceutical and pharmaceutical companies can establish the necessary foundation for the following perational qualifications, verifying the safety, potency, and quality of their products.

Functional Testing


During the IQ phase, attention is given to verifying that equipment, systems, and utilities are installed correctly, meeting strict regulatory requirements and industry standards. IQ acts as the beginning phase, validating the physical installation of machinery and infrastructure against predefined specifications. IQ serves as the starting point to subsequent validation phases, laying the groundwork for rigorous Functional Testing. Through comprehensive IQ protocols, biopharma facilities can instill confidence in the reliability and compliance of their operations, contributing to the delivery of safe and effective pharmaceutical products.

OQ: Operational Qualification


Operational Qualification (OQ) focuses on verifying that equipment operates consistently within established parameters and performs its intended functions accurately. the GL Technologies OQ testing is designed to identify any deviations or inconsistencies in equipment performance that could affect product quality or safety.

Key elements of OQ include


Performance Testing


Performance Testing standing as a key pillar. This phase evaluates the system's performance under normal operating conditions to verify its capability to meet predetermined specifications. Through assessment of factors including speed and accuracy. Performance Testing validates the system's ability to execute tasks effectively. By scrutinizing performance metrics against established benchmarks, OQ makes sure that systems operate within acceptable parameters, maintaining confidence in their functionality and contributing to operational excellence.

Calibration and Maintenance


Calibration verifies that instruments and devices stick to predefined standards, providing accuracy n measurement. At the same time, maintenance protocols guarantee sustained functionality by addressing wear, tear, and potential malfunctions, which upholds operational integrity. Together, calibration and maintenance are the keys to the OQ phase, strengthening the foundation for consistent and compliant in regulated environments.

Standard Operating Procedures (SOPs)


Another key aspect of the OQ phase is the development and implementation of Standard Operating Procedures (SOPs). SOPs detail the precise steps and protocols required to execute specific tasks or operations, serving as a blueprint for consistency and uniformity in performance. These procedures not only define the operational parameters but also outline the necessary documentation and validation processes to verify that systems function within predefined specifications. Through adherence to SOPs, biopharma organizations can uphold quality standards, minimize risks, and meet regulatory compliance standards.  

PQ: Performance Qualification


Performance Qualification (PQ) is the final stage of validation and focuses on demonstrating that equipment consistently produces results that meet predetermined specifications and quality attributes. Our PQ testing is conducted under actual operating conditions using representative materials or products.

Key components of PQ include


Process Validation


involves the meticulous identification and establishment of critical process parameters (CPPs) and critical quality attributes (CQAs) pertinent to the product's quality and safety. Subsequently, the PQ phase meticulously executes protocols designed to verify the consistency and robustness of the manufacturing process under normal operating conditions. This validation stage rigorously evaluates the process's ability to consistently produce product batches meeting predetermined specifications, demonstrating its capability to consistently yield safe and effective biopharmaceutical products at scale.

Statistical Analysis


Statistical analysis plays a pivotal role within PQ, encompassing key components that validate the performance of biopharmaceutical production systems. Central to this analysis are parameters such as process capability, which assesses the ability of a manufacturing process to consistently meet predefined specifications. Additionally, statistical tools like Design of Experiments (DOE) enable thorough exploration of process variables to optimize production efficiency while maintaining product quality.

Quality Assurance


These components include meticulous documentation of process parameters and specifications, thorough testing of equipment functionality, validation of critical process steps, and comprehensive data analysis to verify product consistency and compliance with regulatory standards. PQ also involves conducting risk assessments to identify potential failure points and implementing appropriate mitigation strategies to safeguard product quality. Additionally, PQ encompasses personnel training to ensure competency in operating equipment and executing procedures accurately.

IQ OQ PQ Education


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). Metrology, the science of measurement, plays a vital role in biopharma manufacturing. It includes the calibration, maintenance, and control of instruments used to quantify various parameters critical to the production of biopharmaceuticals. From maintaining accurate dosages to validating environmental conditions, biopharma metrology maintains the integrity of the entire manufacturing process.

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 Irvine and Long Beach.

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

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