Performance qualification: Critical to validation

Agnihotri, Ajju; Kaur, Sukhraj; Kumar, Jitender; Chahal, Ravinder

doi:10.4103/0973-6247.106711

Asian J Transfus Sci

2013

DOI: 10.4103/0973-6247.106711

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Performance qualification: Critical to validation

Ajju Agnihotri

Sukhraj Kaur

Jitender Kumar

et al.

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2024

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An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications

Chaudhary,

Kumar,

Raj

et al. 2024

CIS

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API analysis plays an important role in nourishing the quality, safety, efficacy, and potency of bulk drugs and pharmaceutical formulations. Increased drug products in the market lead to increased demand for new analytical techniques for Active Pharmaceutical Ingredient (API) analysis. During the past decades, method developments were necessitated for drug impurities, excipient profiling, and testing for biopharmaceuticals like dissolution and bioavailability. Moreover, advancements in the pharmaceutical industries necessitate upgrading newer technologies like analytical Quality by Design (QbD) and artificial intelligence. This review focused on analytical method development and its official guidelines provided by various regulatory bodies including ICH, US-FDA, AOAC, and USP. Moreover, this present art also states various validation and system parameters along with their applicability and recommended range. The critical appraisal of analytical technologies for performing various API analyses was also written in a scientific manner. Moreover, applications in recent trends in pharmaceutical industries as well as research were also documented. Hence, this review provides sufficient information for the readers for in-depth information starting from scratch to higher technologies for developing analytical methods and recent trends in the pharmaceutical industry.

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An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications

Chaudhary,

Kumar,

Raj

et al. 2024

CIS

View full text Add to dashboard Cite

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

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Performance qualification: Critical to validation

Cited by 1 publication

References 1 publication

An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications

An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications

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