Author Archive

Examining Containment Strategies in High-Potency Manufacturing

With the increasing use of high-potency APIs, it is more important than ever to have an appropriate containment strategy to protect both the quality of your product and the safety of your personnel. Many important questions should be asked. Have you considered environmental, health, and safety (EH&S) issues early in your product development process? What are OELs and how should you evaluate industrial hygiene exposure? How can you prevent exposure? What elements are crucial for containment?

To examine these questions and others, Pharmaceutical Technology will host a complimentary, educational, live webcast, Containment Strategies in High-Potency Manufacturing, on Thursday, September 12 at 11:00 AM EDT. This 30-minute webcast will focus on current best practices and strategies for containment in high-potency manufacturing.

The webcast will be presented by John Farris, a Certified Industrial Hygienist and president & CEO of SafeBridge Consultants.  John is a recognized expert in the safe handling of potent pharmaceutical compounds.

Audience members will be able to ask questions for additional insight during the live webcast on Thursday, September 12. Additional information and registration for the live webcast and on-demand viewing may be found at www.pharmtech.com/highpotency.

Prepare for Serialization Now

Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week. Momentum toward implementing these technologies across packaging lines is building as deadlines, including California’s requirements in 2015 and others around the world, approach. After listening to several presentations and a panel discussion, the message I heard loud and clear was that time is of the essence and that packagers should prepare for serialization now. Read more »

Efficient Equipment Displayed at INTERPHEX

As I visited the exhibits and attended the conference sessions at INTERPHEX 2013 last week, I noticed a focus on equipment flexibility and ease-of-cleaning and changeover that enables manufacturing efficiency. Read more »

Improving Inhaled-Product Testing

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation. An article in the February 2013 issues of Pharmaceutical Technology and Pharmaceutical Technology Europe, “Improving Inhaled Product Testing: Methods for obtaining better in vitro-in vivo relationships,” discussed testing equipment and techniques. PharmTech recently interviewed the author, Mark Copley, sales director at Copley Scientific, to gain further insight into the importance of this topic. Read more »

Panel Will Discuss Quality by Design at INTERPHEX

Pharmaceutical Technology will be moderating a panel discussion, “Lessons Learned: Successes and Challenges in Implementing Quality by Design,” on Wednesday Apr. 24 from 10:15 to 11:15 at INTERPHEX in New York City. You can listen to a podcast about the panel discussion that is posted on PharmTech’s homepage.

Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co., will provide expertise on application of design space and control strategies for API manufacturing. Dr. Chris Moreton, FinnBrit Consulting, will share his expertise in how to incorporate excipients into the design space. Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management will use his experience to discuss challenges in adapting the manufacturing process from a control perspective. Together, the panel will consider the benefits of adapting QbD and the challenges yet to be addressed. I hope to see you there.

INTERPHEX Conference Previews

Pharmaceutical Technology interviewed some of the speakers for the upcoming INTERPHEX 2013 conference to get a “sneak peek” of their presentations. The first of these, an interview with Par Almhem, president of ModWave and Modular Partners, discusses advances in modularization. Check out the media player on the PharmTech website or click here to listen to the podcast, and look for more to come soon. If you’re at the show, be sure to stop by PharmTech’s booth (Booth #4139).

Experts at Symposium Promote Quality by Design for Analytical Methods

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

Surveying Trends in Equipment Innovation

Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »

A Call to Integrate Technology Innovation and Healthcare

In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »

Elemental Impurities General Chapter Revisions Move Forward

Revisions to the United States Pharmacopeia (USP) General Chapter<231>Heavy Metals have been much discussed over the past decade. USP is in the process of replacing this chapter with General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods, which were published in USP 35-NF 30, Second Supplement. The official date for the new chapters—originally Dec. 1, 2012—was briefly postponed due to an appeals process but was recently re-established as Feb. 1, 2013, as described in today’s PharmTech news article.
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