Qualification

Difference Between Calibration, Validation and Qualification
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Difference Between Calibration, Validation and Qualification

Byipharmacist

In the pharmaceutical industry, calibration, validation, and qualification are crucial processes that ensure the accuracy, reliability, and compliance of instruments, methods, and processes used in drug development, manufacturing, and quality control. While these terms may seem similar, they have distinct meanings and purposes within the pharmaceutical context.   Calibration Calibration in the pharmaceutical industry refers…

Qualification and Validation In Pharmaceutical Manufacturing
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Qualification and Validation In Pharmaceutical Manufacturing

Byipharmacist

WHAT IS VALIDATION? EU GMP – it is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results.   WHAT IS QUALIFICATION Performed to establish evidence that process equipment and ancillary systems are capable of operating within established…