Quality Systems

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States.

The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in a 220–175 vote.

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.

Boehringer Ingelheim decided to voluntarily withdraw its “Silomat” drug, which contains clobutinol hydrochloride, in all countries where it is available.

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Appendix: definitions and regulations, Federal Food, Drug, and Cosmetic Act; Appendix: definitions and regulations, Title 21 Code of Federal Regulations; Appendix: definitions and regulations, Compliance Policy Guides

A comprehensive book helps readers navigate the European drug-approval process.

Going digital can produce high-quality, full-color labels at potentially lower cost.

User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.

Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.

The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.

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Poor processing and misguided projections lead to trashed product.

In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?

Larger and strategic sampling and testing plans can improve process understanding and characterization.

The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.

The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Campaigners for Alzheimer's sufferers to have access to antidementia drugs on the NHS in the early stages of the disease have claimed a small victory in this drugs battle.

Feedback is urged on USP's proposed revisions to the General Notices.

FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.

Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.

Production sometimes follows the law of supply and reprimand.

Washington, DC (June 25)-More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

USP is revising key documents to make them easier to use.

Industry and regulatory experts provide advice on inspection preparation and best practices.

The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.