Manufacturing

Planning ahead will ensure successful efforts to improve packaging and packaging operations.

Advancements add yet another challenge for industry's already overextended regulatory body.

Brief pharmaceutical news items for October 2008.

This article summarizes the classification systems for topical liquid and semisolid dosage forms used for dermatological application and notes some differences between FDA and USP classification.

To err may be human, but to really mess things up, you need management.

Emerging pharmaceutical companies represent an important client base for CROs and CMOs. Lessons learned for successful customer–supplier relations.

Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.

Can previous trends of Democratic and Republican administrations predict industry's future?

A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Cycle design and robustness testing using advanced process analytical technology.

Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...

The International Electrotechnical Commission (IEC) has approved HART 7.1, the WirelessHART Communication Specification, as a Publicly Available Specification (IEC/PAS 62591Ed.1). WirelessHART is the first industrial wireless communication technology to achieve this level of approval.

Eli Lilly and Company plans to launch an online registry of its payments to physicians in 2009.

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.

Regulatory bodies around the world are now revising legislation, regarding counterfeit medicines, good manufacturing and distribution practices, and risk management.

California's ePedigree requirements call for item-level serialization beginning in 2011. The author explains factors to consider when implementing a serialization strategy and how to achieve a positive return on investment.

Pharmaceutical Technology has summarized recent statements by FDA officials on supply chain issues to provde the agency's most up-to-date views and expectations.

SAFC, Regis Technologies, Carbogen Amcis, Cambridge Major Laboratories, and AMRI are among the companies at CPhI Worldwide in Frankfurt this week that are moving forward with expansions.

In the popular view of nanomedicine, miniature robots equipped with a set of tools will one day patrol the inside of the body, cleaning up atheroslerotic plaque, zapping cancer cells, and generally performing repair and maintenance.

The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.

Ionic liquids provide an alternative to certain solvents in select reactions used to synthesize intermediates and active pharmaceutical ingredients.

The days of a 'job for life' at a Big Pharma company seem to be well behind us, whether we're at the bench or in the boardroom, but that doesn't mean we should view the employment landscape with trepidation.

Nanoparticles can also cross the blood–brain barrier, which could make them useful for delivering drugs that target brain tumours or diseases that affect the central nervous system.

The potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.

...an uninformed decision based on commercial requirements alone may, ultimately, have disastrous consequences on the efficacy of the target recombinants.

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...

In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency's priorities, specifically poking at FDA's political appointees and whether they are promoting industry at the expense of the public's health.

On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million.