Metrology Program for cGMP Compliance
When it comes to the pharmaceutical and biotech industries, maintaining compliance with the current Good Manufacturing Practices (cGMP), is essential in today's highly regulated world. A primary aspect of cGMP compliance is the accuracy and reliability of measurements and instruments used in the manufacturing process. To maintain cGMP compliance, many companies are turning to GL Technologies to implement a metrology program to meet their needs.
To speak with the experts about your Metrology cGMP compliance needs, please fill out our online form or give us a call!
Biotech and medical related industries have come to recognize the importance of a comprehensive metrology program to ensure cGMP compliance. The GL Tec metrology pgram is designed to meet the requirements of various regulatory bodies such as the FDA, MHRA, and EMA. Offering a range of services to support our clients in reaching, and maintaining cGMP compliance.
Metrology Equipment Calibration
GL Technologies provides equipment validation services to make sure that your instruments meet cGMP requirements and ultimately, are accurate and reliable. Using the right equipment to perform comprehensive calibrations, our team of experts will make sure your equipment is providing accurate and reliable data.
Equipment Qualification
To achieve cGMP (Current Good Manufacturing Practice) compliance, equipment qualification metrology is an important step for biopharmaceutical industries. It takes a systematic approach to verify that measuring instruments, devices, and laboratory equipment used in the manufacturing process meet predefined specifications & standards. With testing and calibration procedures, qualification metrology will verify the accuracy and precision of your measurement systems, guaranteeing the critical data generated during manufacturing. The GL Technologies equipment calibrations include installation qualifaction (IQ), operational qualification (OQ), and performance qualification (PQ) of your equipment.
Preventive Maintenance
By implementing a proactive approach, biopharmaceutical organizatinos can maintain and calibrate their metrology equipment to prevent any deviations. Inaccuracies or failures can compromise product quality and compliance. With a preventive maintenanec strategy in place, this involves regular inspections, scheduled calibration, and validation of measurement instruments including: balances, thermometers, pH meters, and pressure gauges. When an organization maintains a structured preventive maintenance program, they can meet cGMP standards and minimize risks.
Training
Training encompasses a wide range of activities when it comes to developing and maintaining skills and knowledge of the personnel involved in the metrology processes. GL Technologies can help to implement a training program that covers instrument calibration, measurement techniques, data integrity, documentation, and quality control procedures. Training promoties a culture of compliance and continuous improvement that remains in line with cGMP guidelines.
Documentation
To demonstrate compliance with cGMP regulations, documentation of metrology activities is extremely important. The documentation should include detailed procedures for equipment calibration, qualification, records of measurements, and maintenance. It should also have traceability of measurement standards, certifications of calibration, and training records for personnel involved in metrology processes and activities. With the right documentation, biopharmaceutical organizations can demonstrate a commitment to meeting cGMP requirements for their manufacturing operations.
Calibration and Equipment Qualification Certificates
Preventive Maintenance Records
Training Records
To speak with the experts about your Metrology cGMP compliance 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.
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