Manufacturing

USP promotes horizontal standards for biologics' quality attributes.

While most companies recognise the significance of emerging markets, they struggle to jump the first hurdle in addressing these opportunities: defining the right product.

Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.

The authors review current industry challenges and trends in managing global supply chains and propose best practices for improving visibility into those networks.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.

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.

Graham Rideal of Whitehouse Scientific explains the importance of filter testing and offers some considerations with regards to choosing filter test methods.

Marc Prieur of Aptar pharma describes success stories in emerging markets.

Croatia is on track to join the EU in 2013 and offers a well-developed pharmaceutical market. However, its EU membership application has undergone much scrutiny.

The challenge with any of the emerging markets is in adjusting to the western regulatory concepts of quality and compliance.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand.

The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a World Health Organization presentation.

The DHS announced it has revised tiering assignments for several chemical facilities covered under DHS's Chemical Facility Anti-Terrorism Standards program, which requires chemical companies to develop and implement specific security plans for their facilities.

FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season.

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.