Manufacturing

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.

Experts in solid dosage discuss the formulation and manufacture of multilayer tablets.

Traditionally more prevalent in less industrialised regions, counterfeit medicines are now more frequently entering the heavily regulated supply chains of EU countries.

Boehringer Ingelheim's Heribert Häusler tells us about parametric release and real-time testing.

Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.

The authors describe a new assembly for bulk and final drug product filling operations.

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.

The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.

We need to measure the particle size of a moisture-sensitive powder. We would like to use dry analysis on our laser-diffraction system, but the particles are fragile and we're struggling to get robust results. Is wet measurement with a nonaqueous solvent the only option?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2012 edition from ACS Valves and G-Con.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.

Industry optimism is on the rise for 2012.

New educational programs are key to the industry's future and to safe, available drugs.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

New product reviews for February 2012.

Debottlenecking downstream mAb purification.

ICH Q8, Q9, and Q10 support and implications for the future.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.

The scandal surrounding Servier's diabetes drug, Mediator, continues to unravel in France and could have implications for the whole pharmaceutical industry as the country scrutinises its regulatory systems.

This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators.