The analytical instruments used by the quality control laboratory to determine if the raw material and final products accomplish or not the established quality levels must be strictly controlled and often qualified.
The qualification of the analytical instruments is one of the most important points within the quality plan of all the companies.
Developing the required documentation and executing the different tests included in the qualification of the analytical instruments is one of the process that Qualipharma masters.
En la cualificación de instrumentos analíticos disponemos según la USP de tres categorias:
Group A: includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements.
Group B: includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits. Some of them are balances, melting point apparatus, light microscopes, pH meters, variable pipets, refractometers, thermometers, titrators, viscometers, muffle furnaces, ovens, refrigerator-freezers, water baths, pumps and dilutors.
Group C: includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application. Examples of instruments in this group are: atomic absorption spectrometers, differential scanning calorimeters, dissolution apparatus, electron microscopes, flame absorption spectrometers, high-pressure liquid chromatographs, mass spectrometers, microplate readers, thermal gravimetric analyzers, X-ray fluorescence spectrometers, X-ray powder diffractometers, densitometers, diode-array detectors, elemental analyzers, gas chromatographs, IR spectrometers, near-IR spectrometers, UV/Vis spectrometers, inductively coupled plasma-emission spectrometers, others.
According to USP 31/NF 28 we carry our out every phase of qualification: DQ, IQ, OQ y PQ.
- Minimize cost related to the equipment performance
- Verification of the instrument reliability and accuracy
- Improvement of the department workflow