Newsletter | June 26, 2014

06.26.14 -- FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't

Pharmaceutical Online Newsletter
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» From The Editor
FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
On June 10, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang of KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
Featured Focus: Manufacturing
How To Choose The Right Feeder For Your Process
By Sharon Nowak, Coperion K-Tron
Volumetric feeders control flow by discharging a consistent volume of material. They are best used when bulk density is consistent, long-term feed accuracy is not critical, and feeder performance does not need to be documented.
WHITE PAPER: Improve Efficiency In Biocontamination Control And Risk Mitigation
By James Drinkwater, Bioquell Inc.
There is a need to improve the efficiency in the pharmaceutical industry to meet new challenges of globalization, competitiveness, and the increasing diversity of products.
APPLICATION NOTE: Transforming Liquid SMEDDS Into Tablets And Capsules
APPLICATION NOTE: Reducing Manufacturing Risk During Cleanroom Maintenance And Downtime
PRODUCT: Semiautomatic Pharmaceutical Filling Machine For Aseptic Bags
» Critical Environments
WHITE PAPER: Top 10 Considerations When Selecting An Isolator Supplier
By Gary Partington, Walker Barrier Systems
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier to be certain that you are getting what you are paying for, before the purchase order is written.
WHITE PAPER: Large-Scale Biodecontamination With Hydrogen Peroxide Vapor
BROCHURE: Sterilizer Process Controller
WHITE PAPER: Fired Up: Combustible Dust Raises Explosive Issues
By Paul R. Miller, Nilfisk Industrial Vacuums
By now, most manufacturers are familiar with the story of combustible dust. They've read about it in the newspaper, Googled it online, watched it on a CBS 60 Minutes special, or received a letter from the Occupational Safety and Health Administration (OSHA) informing them their facility is considered high-risk for a combustible dust explosion.
WHITE PAPER: Probiotics In Pharmaceuticals: Friendly Bacteria
By Kevin Ward, Biopharma Technology Limited
Probiotic bacteria have long been used in probiotic yogurt drinks or provided in tablet form. People have often taken these 'friendly' bacteria to help boost their own systems' internal flora and fauna; friendly bacteria can help protect our immune system and aid digestion. Bacteria have been known to survive a variety of conditions; however, storage in yogurt drinks or tablet form is often not enough.
PRODUCT/SERVICE: EMC Documentum Research And Development
» Supply Chain
GUEST COLUMN: Do Chinese Hamster Ovarian (CHO) Cells Specimens Require An Import/Export License?
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
WHITE PAPER: Are There Any Markets Left To Emerge?
BROCHURE: AT&T mHealth Platform
» Inspection
APPLICATION NOTE: In-Line Headspace Oxygen Monitoring For Liquid And Lyophilized Products
CASE STUDY: Risk Mitigation With Pouch Packaging Inspection
PRODUCT: Metal Detection System: Observer
» Packaging
BROCHURE: Continuous Reliability Program Dispenser Preventative Maintenance Service
VIDEO: Precisely Fill Vials With In-Turret Check Weigh
PRODUCT: Contract Packaging: Stick-Pack Uni-Dose Packing
ChemOutsourcing is the largest U.S.-based API show attracting annually 700 to 800 chemists from the pharmaceutical, biotech, and chemical industries. The show focuses on API development spanning early drug discovery through chemical development and commercial supply. Attendees are executive scientists from pharmaceutical companies responsible for sourcing starting materials, intermediates, and active ingredients, and experienced in working with contract research and contract manufacturing organizations. Learn more.

Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST
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