Pharmaceutical Technology-01-02-2013

The Future of Pharma Manufacturing

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

New product reviews for December 2012.

From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.

A round up of news from across the web, including trends from social social media platforms.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.

The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.

Will international biomanufacturing outsourcing become mainstream in this decade?

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.

Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.

Dr. Charles Kettler, director of Natoli Scientific, looks at the challenges that tablet scoring poses to tablet manufacturers.

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area.