Manufacturing

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.

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2011 edition from BETE Fog Nozzle and Continental Disc.

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?

The same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.

Ideally, all product formulations should experience the same conditions when it comes to lyophilisation, but in practice, however, nucleation can occur.

SOCMA has issued its support this week of the passage of pending free-trade agreements with South Korea, Panama, and Colombia by two Congressional committees.

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 recent industry survey shows keen interest in improving bioreactors and cell-culture media.

The increase in aseptic processing driven by the growing number of biologically-derived products has led to an increase in freeze-drying applications in this area at both research and production scales.

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

The performance of biotechnology venture capital and investment is lackluster at best.

Getting an answer is easy-asking the right question is apparently more difficult.

Editor's picks of new manufacturing products for July 2011.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

High demand could lead to innovation in controlled-release injectables.

US support of regenerative medicine is essential for maintaining a lead on healthcare innovation.

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

Better strategies and practices in sourcing and procurement can contribute to the bottom line.

Pharmaceutical manufacturers look to various solutions to resolve the challenge of poorly soluble drugs

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.

Which route will we take to arrive at a national stem-cell policy?

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

Switzerland is an important power in Europe's pharmaceutical industry.

Product degradation is often overlooked compared with other supply chain issues, but if left unchecked can lead to the market entry of substandard medicines, whether through ignorance or gross negligence.