Quality Systems

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

The heightened focus on risk raises concerns about delays in approving new drugs.

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.

While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.

New standards may overlook critical qualification needs.

New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material.

The authors used a light-transmission-based static division system to detect particles of foreign contaminants in prefilled vials.

This article provides an update to the author's Viewpoint column, "Changes to Vial Labels May Affect Patient Safety," which ran in Pharmaceutical Technology's March 2009 issue.

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.

With counterfeit drugs on the rise, the Chairman and CEO of Ahura Scientific discusses the issue and explains how a handheld device is helping companies to tackle the problem.

The House Energy and Commerce Committee approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009," a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program.

Also, FDA's DDMAC issues Warning Letter to King Pharmaceuticals; draft guidance released for SPL standards for content of labeling.

The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office (GAO) that was released this week.

New barcoding technologies are helping to aid product traceability and fight counterfeits. Mark Beauchamp of Citizen Systems Europe explains how.

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus.

Also, USAID and USP launch counterfeiting public service campaign in Cambodia.

The US Food and Drug Administration issued an alert to healthcare professionals of a change in heparin manufacturing that is expected to decrease the drug's potency.

Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting...

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.