The primary objective of calibration is minimizing any uncertainty in measurements. It reduces errors in measurement to an acceptable level, which is critical for every stage of the FDA approval process. Any product that is FDA approved has been analyzed, examined and tested, and its benefits have been found to outweigh its potential risk.
The U.S. Food and Drug Administration (FDA) is responsible for:
- Protecting public health by ensuring that foods are safe for consumption
- Ensuring food products are sanitary and labeled properly
- Regulating veterinary and human drugs, vaccines and other such biological products, including medical devices are safe and effective
- Protecting the public against exposure to radiation from electronic products
- Assuring cosmetic products, dietary supplements and other such products are safe for consumption and labeled properly
- Regulating tobacco products
- Advancing public health and safety by speeding up product innovations
FDA REQUIREMENTS:
Over time and with repeated use, the accuracy and precision of every instrument tends to drift. To be confident about the reliability of the measurements being taken, regular service and maintenance are needed to ensure the performance of the instrument throughout its lifetime.
The primary objective of calibration is minimizing any uncertainty in measurements. It reduces errors in measurement to an acceptable level, which is critical for every stage of the FDA approval process.
Calibration requirements for equipment are defined by Title 21 of the FDA’s Code of Federal Regulations.
- Manufacturers need to ensure inspection, measuring and test equipment is suitable for the intended purposes and capable of producing results that are valid. They must include proper provisions for handling, preserving and storing equipment.
- Calibration must be performed routinely and if there are any errors found, corrective action needs be taken, and any adverse effects caused need to be evaluated and documented.
- Associated activities like maintenance, preservation and storage need to be recorded and documented. The procedures need to be easily accessible to the personnel performing the calibration and must include specific directions on how the calibration is to be performed and acceptable limits for accuracy and precision.
- The standards used to inspect, measure and test equipment should be traceable to national or international standards.
FDA GUIDELINES:
- Calibration must be performed routinely, as per written directions
- Document the calibration of every device that needs calibration
- Specify the acceptable limits for accuracy and precision
- Train calibrations personnel
- Use calibration standards that are traceable to the National Institute of Standards and Technology (NIST), other acceptable standards, or in-house standards if necessary
- Make provisions for evaluating adverse effects caused by malfunctioning equipment and procedures for remedial action
For more than 30 years, Scientific Instrument Center has served businesses. We provide thorough, honest, and dependable services specializing in scientific equipment maintenance and scientific equipment calibrations.
To inquire about our services, you may contact us or give us a call at (614) 771-4700.
We are here to answer any questions you may have.
