Quality Systems

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.

A good electronic records managment program will not just impress regulators. It also can boost profitability.

This article describes the Part 11 requirements that companies must address when automating their quality management processes and offers practical tips for compliance.

Glossary of computer and software terms.

Nearly eight years have elapsed since the US Food and Drug Administration's 21 CFR Part 11 regulations on the use of electronic records and electronic signatures went into effect (1). In Sept. 2003, FDA issued a guidance document covering the scope and application of Part 11, which described how the agency intends to interpret and enforce the requirements during its ongoing re-examination of the regulations (2). Many in the pharmaceutical industry view the guidance as a positive development that will lead to a simplified FDA approach to Part 11 and a significant reduction in the industry's compliance burden. But this shift in FDA's interpretation and its intended use of enforcement discretion has not ended the controversy and confusion surrounding Part 11 and its requirements.

The confusion surrounding the application of 21 CFR Part 11 can be solved by focusing on the common rationale that both protects the public health and drives the fundamental basis of the industry's business: good science.

The use of quality management software (QMS) to automate manufacturing quality processes quickly is becoming an industry-wide initiative. Companies are turning to commercial off-the-shelf systems (COTS) to simplify implementation and validation efforts. Regardless of the system selected, the automation of these critical quality processes is subject to electronic records and electronic signatures (ER/ES) requirements, as set forth in the 21 CFR Part 11 regulation (1). Therefore, companies must adopt a comprehensive but manageable approach to Part 11 compliance as they begin to automate the processes that support product quality and efficacy to ensure they meet the requirements of good manufacturing practices and all predicate rules.