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Research Journal of Pharmaceutical Dosage Forms and Technology
Year : 2020, Volume : 12, Issue : 1
First page : ( 17) Last page : ( 26)
Print ISSN : 0975-234X. Online ISSN : 0975-4377.
Article DOI : 10.5958/0975-4377.2020.00004.X

Review on Pharmaceutical Validation

Ghagare Prajkta M.*, Patil Ashwini R., Deshmane Bhavna J., Kondawar Manish S.

Appasaheb Birnale College of Pharmacy, South Shivajinagar, Sangli-Miraj Road, Sangli-416416

*Corresponding Author E-mail: prajktaghagare95@gmail.com

Online published on 10 August, 2020.

Abstract

Validation is the art of designing and practicing the designed steps alongside with the documentation. The process validation provides documented evidence to ensure that a particular method consists of producing a product that follows the defined requirements and quality characteristics. Validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Creation of methods for the interested portion in finished product or process tests and sample preparation of the drug product and providing realistic approaches for determining the selectivity, specificity, detection limit, quantity limit, linearity, accuracy of the range, precision, consistency of the recovery solution, robustness and robustness of liquid chromatographic methods. Legitimacy is therefore an essential component of quality assurance and pharmaceutical chemistry.

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Keywords

Standard Operating Procedures, Process Qualification, Operational Qualification, Limit of Quantitation, Limit of Detection.

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