Articles By Trisha Gladd
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FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
11/21/2014
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
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HDMA Conference Examines A Holistic Approach To DSCSA Preparation
10/30/2014
As the first Drug Quality and Security Act deadline approaches, pharma professionals around the globe are offering insight and advice in order to help with preparation for this legislation. While any Google search will return pages of helpful articles, the most beneficial information will be offered in real time at conferences and seminars arranged by industry organizations. One example of this is the 2014 Healthcare Distribution Management Association (HDMA) Education Traceability Seminar taking place in Arlington, VA from November 10th to the 13th. According to its site, the seminar will “include valuable insights, innovative approaches, and lessons learned as distributors and manufacturers successfully implement serialization and traceability technologies.”
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2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches
10/28/2014
Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.
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Supply Chain Security: 3 Visions To Prevent Fraud And Safeguard The Patient
10/27/2014
The vulnerability of the pharmaceutical industry’s supply chain has been talked about in great depth, especially since the passing of the Drug Quality and Security Act (DQSA) last November. Millions of stolen, counterfeit, and illegal medications infiltrate pharma’s shipping lanes every year, and despite all of the buzz, experts are pumping out viable solutions at a much slower rate than criminals are distributing contaminated and/or fake drugs.
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USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
10/1/2014
The US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.
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Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert
9/11/2014
Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management. For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.
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GSK Discusses The Transformation Of Biopharmaceutical Manufacturing: Single Use Is Only Part Of The Strategy
8/26/2014
Historically, biopharmaceutical manufacturing has always been slow, expensive, and inflexible. However, the pressures in today’s biopharma space are driving trends in the opposite direction, which is causing experts to look for ways to drive costs down while improving flexibility and efficiency. GSK’s Randy Maddux, VP and Site Director of the company’s Global Manufacturing and Supply (GMS) site in Rockville, believes there are many factors involved in transforming biopharmaceutical manufacturing. And while single-use technology plays a key role, there are plenty of other aspects to consider.
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BPI Offers A Look Into QbD At Genentech
8/19/2014
Brian Horvath, Scientist and Technical Development Team Leader, Late Stage Cell Culture at Genentech, says the company’s QbD approach has been evolving over the past several years. It is used in a number of ways in the bioprocess areas—cell culture, purification, and formulation—which allows validation that the process as a whole reliably produces product with the desired critical quality attributes. In October, Horvath, will present a case study at the BioProcess International Conference and Exhibition outlining how QbD was used at Genentech during the characterization of a CHO-based monoclonal antibody.
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How To Prepare A Facility For The Biopharmaceutical Revolution
7/8/2014
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
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Analytical QbD at Teva: Knowledge Is Power Only When You Share It
7/3/2014
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.