It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving atte...

The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Method d...

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. It is the process of defining an analytical requirement, and confirms that the meth...

BACKGROUND: infrared imaging has emerged as a new promising tool in histopathology to provide label free analysis of tissue sections. Interestingly, infrared imaging has the potential to measure many markers at the same time, on one section, without staining. It has been demonstrated to deliver accurate results in numerous cancer pathologies. Yet, today, it is not used in routine diagnostics. T...

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product-specific acceptance criteria and stability of results. Validation should demonstrat...

Analytical methods validation is an important regulatory requirement in pharmaceutical analysis. High-Performance Liquid Chromatography (HPLC) is commonly used as an analytical technique in developing and validating assay methods for drug products and drug substances. Method validation provides documented evidence, and a high degree of assurance, that an analytical method employed for a specifi...