Quality Control

Editorial: What Is Your Company's Back Up Plan?

This week Endo Pharmaceuticals reported that several of its products may experience a "constraint" or "disruption" in supply following the temporary shutdown of Novartis Consumer Health Inc.'s Lincoln, NE, manufacturing facility, where these Endo drugs have been manufactured.

Broken Tablets, Possible Mix-Ups in Packaging Lead Novartis to Recall Certain OTC Drugs

Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall.

Investigating Glass Delamination

A researcher tackles some commonly asked questions about the delamination issues that have been troubling the industry.

A spate of drug recalls earlier this year has renewed attention on their cause: glass delamination. Glass vials have been long considered safe because of their longevity in the industry.

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Editorial: Should Industry Step Up Redundancy to Prevent Drug Shortages?

To address what is becoming a "significant public health problem," FDA this week released the report, "A Review of FDA's Approach to Medical Product Shortages." In particular, it details several agency concerns about sterile injectables, which have accounted for the majority of drugs in short supply. FDA's findings bring to mind the number of drug recalls the industry has seen over the last couple years because of quality concerns.

Uhlmann’s Push for PAT

By Marie Redding
Freelance Writer

Uhlmann VisioTec began focusing on PAT solutions in 2000, but it became a major initiative in 2004 and 2005. Since then, Christoph Lehmann, director, Uhlmann VisioTec, says this business has been continually increasing. The company provides certain tools that can support many different approaches to PAT. “The more a company does, the more they can save,” says Lehmann.

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PMP News Welcomes Three New Editorial Advisory Board Members

We are pleased to announce that three packaging professionals have joined our Editorial Advisory Board:

Michael Forehand, Principal Packaging Engineer, Global Engineering and Technology, AstraZeneca Pharmaceuticals;

Dan Penny, Director of Packaging Engineering, Cardinal Health;

and Edward M. Dunn, Senior Director Packaging Technology, Merck Manufacturing Division.

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Quality In Packaging

Members of PMP News's Editorial Advisory Board focus on trends in package quality assurance.
Inspection technology and supply chain controls are helping to ensure packaging quality and product protection, as pharmaceutical and medical device manufacturers face demands for user-friendly packaging. Speaking on the issue for this year’s Industry Outlook are the following members from PMP News’s Editorial Advisory Board: John Bitner, director of packaging development, Watson Pharmaceuticals; D. Bruce Cohen, principal,
PackTechPlus LLC; Michael L. Forehand, principal packaging engineer, global engineering and technology,
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To Do More with Less, Develop a Portfolio Management Process

Cost-cutting is a frequent task of today's packaging engineer. Pharmaceutical and medical device manufacturers are looking to reduce costs wherever they can, so engineers must balance new packaging development with savings-minded product life cycle management.

But how can packaging engineers possibly juggle this increasing workload? Companies must develop a portfolio management process for prioritizing all projects, advises Stephen Birtsas, a manager with global innovation management consultancy Kalypso.

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Maintaining Critical Quality Attributes through Sorbents

Pharmaceutical manufacturers are delving deeper into understanding the sensitivities of their drug products, with many finding that they require more than just an off-the-shelf solution.

Thanks to ICH Q8 on Pharmaceutical Development, considerations such as Quality by Design, Critical Quality Attributes, and Design Space have crept into day-to-day drug development and production, influencing several packaging decisions. In essence, these concepts have encouraged drug manufacturers to better understand drug stability, resulting in a closer examination of risks using science.

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Rx-360 Can Advance Audit-Sharing Plans after Positive FTC Opinion

The U.S. Federal Trade Commission (FTC) does not plan to challenge Rx-360 on its audit-sharing programs in which pharmaceutical and biotechnology companies share supplier-audit information and expenses. According to Rx-360, this decision will enable the consortium to proceed with plans to implement its audit sharing programs.  

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