Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Market opportunities exist in the development and validation of liquid chromatography methods and instruments for pharmaceuticals, emphasizing compliance with stringent US EPA and FDA standards to ...

Approved by the Royal Society of Chemistry for purposes of continuing professional development (CPD). The course will provide you with the requisite scientific knowledge and understanding of ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...