The process verifies if the compliance and quality standards are being met by a product in real time.
In a pharmaceutical facility, the validation program establishes that a company is meeting current good manufacturing process (c GMP) guidelines that are set for the industry by concerned regulatory bodies.
Instrument qualification has become an important part of pharmaceutical c GMP and is a crucial stage to ensure high-quality products.
Analytical instrument qualification involves phases that can be categorized into: When looking to outsource the activities of validation, qualification and calibration of instruments, it is crucial to choose the right partners.
It is important that the instruments are calibrated frequently, but unfortunately, there is no straight answer for how often they should be calibrated.
Different instruments have different calibration needs, and they cannot be calibrated every time an instrument is used because of cost.
It can be further divided into installation qualification (IQ), operation qualification (OQ) or performance qualification (PQ).
At the same time, make sure to use the right instrument for the required application.The cost of research and development (R&D) has gone up, related generics have been launched, and the price of medicine has been increased due to pressure from the U. Food and Drug Administration (FDA) and health care systems.All this has compelled pharmaceutical facilities to make changes in the way they operate — developing creative business solutions, merging with other companies to utilize R&D resources more efficiently, reducing their production workforce and outsourcing good manufacturing practice (GMP) activities to specialized service providers.When the instrument does not perform within the acceptable range of error, its quality will be greatly affected.Calibration guarantees the quality is not affected by constant errors.