CALIBRATION AND VALIDATION AS PER ICH AND USFDA GUIDELINES

Validation is an important part of Analytical as well as Bio-Analytical Method. The procedures involved in checking data or programs for correctness, compliance with standards and conformance with the requirement specifications. It is establishing documented evidence, which provides high degree assurance that a specific process will consistently produce a    product meeting its predetermined specification and quality characteristics. Calibration is totally differ from Validation But it is an integral part of validation.

KEY WORDS: ICH Guidelines, FDA Guidelines, validation, calibration.