Pharmaceutical Technology, January 2013 Issue (PDF)
The Future of Pharma Manufacturing
Standards-Setting Activities on Impurities
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.
A Look Ahead at Manufacturing and Regulation
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.
The Transformation to Process-Centered Organization
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
The Latest in IT/Automation/Process control
New product reviews for December 2012.
A Look Ahead for 2013
From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.
Pharma Conversation & Community
A round up of news from across the web, including trends from social social media platforms.
Strategies in API Scale Up
Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.
Report from Brazil January 2013
The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.
X-ray Powder Diffraction Pattern Indexing for Pharmaceutical Applications
The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.
Offshoring Biomanufacturing
Will international biomanufacturing outsourcing become mainstream in this decade?
Falsified Medicines Directive Takes Shape in Europe
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.
EMA and FDA on Process Validation
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.
Validation Requirements for Disinfection Efficacy
Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.
The Challenge for Manufacturers in Tablet Splitting
Dr. Charles Kettler, director of Natoli Scientific, looks at the challenges that tablet scoring poses to tablet manufacturers.
Drug Quality at Center Stage for FDA and Manufacturers
Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.
Tablet Splitting: A New Focus for Regulators
Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area.
