Quality Systems

Warning Letter: Similasan

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

Commissioner Crawford’s top priority is to restore public confidence in FDA oversight of drug safety and quality.

New Guidance May Speed Generic Approvals

The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.

Warning Letter: Cape Drugs

Warning Letter: Merck & Co.

Chiron Corporation (Emeryville, CA, www.chiron.com) announced that quality problems at its Marlburg, Germany, manufacturing plant will prevent the company from supplying its "Begrivac" influenza virus vaccine to non-US markets for the 2005–2006 flu season.

Although new drug development usually focuses on clinical and preclinical research, moving innovative products from clinical testing to market mainly involves overcoming manufacturing capabilities and production challenges. Ensuring access to consistently high-quality critical vaccines and therapies needed to counter bioterrorism attacks is a topic frequently debated. Product shortages are leading to policies that expand US drug and vaccine manufacturing and ensure that US regulatory and healthcare policies avoid erecting roadblocks to high-quality drug production.

Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.

The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.

Able Labs Files for Chapter 11

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Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection

Able Laboratories, Inc. (Cranbury, NJ, www.ablelabs.com) announced in late May that it would halt all production and recall all available product because of problematic testing procedures discovered during an internal investigation. The company manufactures mostly generic prescription drugs, including drugs containing acetaminophen.

Proposals to expand drug adverse event monitoring will publicize emerging safety concerns and strengthen post-marketing compliance efforts.

At Convention 2005, USP's constituents ratified resolutions to continue and expand USP's international activities.

Warning Letter: Pragmatic Materials

Warning letter: C&M Oxyfill

Pharmaceutical science and technology news.

Regulation: FDA Steps Up Action Against Counterfeit Drugs, Warns US Consumers Against Fake Medicine from Mexico

A myopic focus on short-term growth can endanger the community. The question is, can we enlighten our self-interest before the edifice falls down around our ears?

Officials at the US Food and Drug Administration are working with industry and academia to develop more efficient and reliable drug production processes that can ensure a consistent supply of high-quality therapies. A modern manufacturing system based on harmonized regulatory policies across global regions is critical for meeting public demand for safe and effective medicines, while also reducing production costs and eliminating waste.

In his Feb. 2005 viewpoint article, "In Defense of Singlet Testing," Torbeck (1) draws an important philosophical distinction between "standards" and "specifications." He argues that specifications are criteria selected by manufacturers for statistical control of their products, whereas compendial standards are absolute requirements. This distinction is entirely compatible with modern concepts of statistical process control.

Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques.