A change in the surrounding atmospheric conditions will cause a drift in the measurement, and regular calibration will keep this drift within acceptable limits.
Periodic calibration will ensure the measurements and outputs achieved are accurate at all times without affecting the quality of the final product.
This is crucial for processes where the quality of measurement is directly related to the quality of the product.
Certain measurements will be affected by ambient condition such as temperature, pressure and humidity.
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.Every pharmaceutical plant will have an IT system to control, support and document the processes.Computer system validation is a key element because it ensures all the IT applications fulfill their intended purposes.This article will discuss the most commonly outsourced GMP processes: validation, qualification and calibration.Validation is a systematic approach where data is collected and analyzed to confirm that a process will operate within the specified parameters whenever required and that it will produce consistent results within the predetermined specifications.
Different phases of design, development, testing and routine of the software being used by the computer system have to be controlled during its life cycle.