Validating pharmaceutical dating age difference rule of thumb

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It is one of the major parts of pharmaceutical manufacturing standards and quality assurance because of these reasons: With regular use and time, instruments and devices used in the industry will undergo damage, which causes a shift in the measurements.

Regulatory inspection will help in tracking the shifts and rectifying through calibration.

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.

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.

Validation efforts must be focused on important aspects that include risk analysis and an in-depth validation approach.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.Validation produces the documented evidence that a process, a procedure or a method fulfils the previously specified requirements reproducibly in practical use.As part of Good Manufacturing Practice, validation is the proof that a process has been checked against the original requirements (and is suitable for a specific task).

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