Manufacturing

Articles

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

Regulatory Roundup: USP Releases Proposed Supply Chain Guidelines

When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination&#151;ultimately compromising patient safety.

Supply chain security boot camp

Amy Ritter was Scientific Editor, BioPharm International.

On Nov. 17, 2011, a bill that would increase penalties for those convicted of trafficking in counterfeit drugs was introduced in the House of Representatives. The Counterfeit Drug Penalty Enhancement Act of 2011, cosponsored by four US Senators and two US Representatives.

House Bill Would Stiffen Penalties for Drug Counterfeiters

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation.

EMA Addresses Globalized Supply Chain Issues With Annex 16 Revisions

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pharma companies and their suppliers are tasked with managing an evermore complex clinical-trial material supply chain.

Managing the Global Clinical-Trial Material Supply Chain

Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm.www.bluespherehealth.com

It is very difficult to measure the problem of counterfeiting accurately from year to year; by definition criminals don?t file tax returns or publish quarterly earnings.

Applying Universal Anticounterfeiting Technologies

In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.

Europe Prepares To Battle The Counterfeiters

Europe establishes new collaborative system to track products.

Inside EDQM: Mass Serialization to Combat Counterfeit Drugs

Angie Drakulich was editorial director of Pharmaceutical Technology.

Deborah Autor testifies before US Senate HELP committee on requested authorities to improve pharma supply chain.

FDA and Senate Call for Urgent Supply Chain Attention

Xavier University, in partnership with FDA, will hold a conference in October to focus on the changing regulatory, business, and operational issues affecting the global pharmaceutical supply chain.