Pharmaceutical Technology-01-02-2013

Pharmaceutical Technology

Pharmaceutical Technology, January 2013 Issue (PDF)

January 02, 2013

Issue PDF

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The Future of Pharma Manufacturing

Standards-Setting Activities on Impurities

January 02, 2013

Inside USP

37

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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

January 02, 2013

Cover Story

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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

January 02, 2013

BioForum

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

The Latest in IT/Automation/Process control

January 02, 2013

Product Spotlight

37

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New product reviews for December 2012.

A Look Ahead for 2013

January 02, 2013

From The Editor

37

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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

January 02, 2013

News

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

Strategies in API Scale Up

January 02, 2013

API Synthesis and Manufacturing

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

Report from Brazil January 2013

January 01, 2013

Global Feature

37

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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

January 01, 2013

Peer-Reviewed Research

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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

January 01, 2013

Outsourcing Outlook

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Will international biomanufacturing outsourcing become mainstream in this decade?

Falsified Medicines Directive Takes Shape in Europe

January 01, 2013

Regulation & Compliance

37

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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

January 01, 2013

Ask the Expert

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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

January 01, 2013

CMC Troubleshooting

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

The Challenge for Manufacturers in Tablet Splitting

January 01, 2013

Special Feature

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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

January 01, 2013

Regulation & Compliance

37

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

Tablet Splitting: A New Focus for Regulators

January 01, 2013

Special Feature

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