A Review on Pharmaceutical Validation and Its Implication

Shalini Sharma, Gaurav Khurana, Rohit Gupt

Abstract


The process validation is establishing documented evidence which provides high degree of assurance that a specific
process consistently produces a product meeting its predetermined specifications and quality characteristic.
According to GMP validation studies are essential part of GMP these are required to be done as per predefined
protocols. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods
employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality
assurance.

Keywords


GMP, Quality Assurance, Pharmaceutical Validation

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DOI: https://doi.org/10.30750/ijpbr.1.3.14

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