Metrology OQ Protocols

With biotech, healthcare, research, and related industries, metrology plays a vital role in providing accurate measurements to ensure quality control, compliance with regulations, and cost savings. But the reliablity of measurements will depend on the performance of the metrology equipment that is being used. This can be affected by various factors including environmental conditions, operator skills, and calibration status. A variety of companies in varying industries rely on GL Technologies to perform operational quality testing to meet their specific needs and industry regulations.

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

858-202-1408

OQ Testing Specialists

The OQ testing process that verifies metrology equipment works to make sure that the equipment is performing its intended functions under normal operating conditions and within predefined tolerances. There are various OQ tests (accuracy, precision, linearity, repeatability, and stability), that assess the metrology equipment performance against its specifications and acceptable criteria. This also includes documentation of the test results which ultimately is serves as evidence of compliance with regulatory standards.

GL Technologies is well versed in metrology equipment OQ services. Our team has years of experience in providing metrology solutions to biotech, pharmaceuticals, medical devices, and related industries. We offer a a range of OQ testing services which includes:

Temperature Mapping
Humidity Mapping
Cleanroom Validation
Pressure Mapping
and Airflow Studies

Operational Quality Procedures

We have worked hard over the years to earn the trust of our clients for their OQ testing and maintaining regulatory standards in the research process; the GL Technologies team provides testing for the following:

Purpose

Our goal is to make sure the metrology equipment is capable of producing accurate and reliable results that meets regulatory and quality standards.

Procedure

OQ procedure involves testing the equipment under various operating conditions, such as at different temperatures, speeds, or loads. The equipment's performance is compared against predetermined specifications, and any deviations are documented and addressed.

Documentation

All OQ testing activities are thoroughly documented, including the test methods, results, and any deviations from specifications. This documentation should be included in the equipment's validation file.

Validation

In general, the OQ is part of a larger validation process which includes installation qualification, and performance qualification.

Frequency

GL technologies recommends that OQ be performed after installation or major maintenance, then periodically checked to make sure the equipment operates within its specified limits. The frequency of testing varies from client to client along with the risks associated with its failure.

Compliance

Organizations understand OQ testing needs to be performed in accordance with regulatory requirements (and standards), such as ISO 17025 or FDA regulations.

Helping Our Clients with Metrology Equipment Needs

When you work with GL Technologies for your OQ needs, you can benefit from:

Increased confidence in the accuracy and reliability of your measurements
Compliance with regulatory standards, such as FDA, ISO, and GMP
Reduced risk of quality issues, rejections, and recalls
Improved productivity, efficiency, and cost-effectiveness
Professional expertise and support from certified metrology technicians

Metrology OQ Education Corner

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.

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.

Metrology Best Practices for Elevating Biopharma Operational Quality

Precision, accuracy, and reliability are vital in the biopharma and pharmaceutical industries. From manufacturing processes to quality control measures, every aspect demands extensive attention. One element that maintains the efficacy and safety of biopharmaceutical products is metrology, the science of measurement. Let's dive into the significance of metrology in the biopharma industry and explore best practices to elevate operational quality.

About 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.