Volume : 11, Issue : 01, January – 2024
Title:
CALIBRATION AND VALIDATION AS PER ICH AND USFDA GUIDELINES
Authors :
PT.Nagaraju* ,B.V.Ramana* ,A.Nandini
Abstract :
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.
Cite This Article:
Please cite this article in press Puduru Thogata Nagaraju et al., Calibration and validation as per ich and usfda Guidelines, Indo Am. J. P. Sci, 2024; 11 (01).
Number of Downloads : 10
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