Analytics

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group.

We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.

A PQRI expert working group provides case study examples of risk-management applications.

A PQRI expert working group provides case study examples of risk-management applications.

Pharma's drive for manufacturing efficiency is bolstering particle-characterization technologies.

The authors investigate the influence of hydro-alcoholic media on hydration and drug release from polyethylene oxide extended-release matrices.

The current review describes the role and selection of excipients, pellet core, coating materials, and compression with various cushioning agents.

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Ensuring compliance though increased statistical knowledge and resources.

A holistic approach to establishing robust control measures.

Industry associations will soon provide new recommendations about extractables and leachables.

Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.

How do you assign a minimum sample weight for a US Pharmacopeia <41> balance application when the tested repeatability gives a standard deviation of zero?

Editor's picks of analytical instrumentation products for May 2011.

The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

Warner Chilcott announced in a press release on Apr. 18, 2011, its intentions restructure, placing 500 Western European jobs on the line.

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.

To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA?s Office of New Drug Quality Assessment.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

Editor's picks of analytical instrumentation products for April 2011.

The hardest errors to spot are the ones that don't look like errors at all.