ARTICLES BY TRISHA GLADD
HDMA Conference Examines A Holistic Approach To DSCSA Preparation
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.”
2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches
Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and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.
Supply Chain Security: 3 Visions To Prevent Fraud And Safeguard The Patient
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.
Compliance In The Supply Chain: 3 Best Practices To Manage Regulations Around The Globe
As if it isn’t challenging enough to maintain compliance with the regulation agency of the country you’re located in, anyone doing business in pharma also has to maintain compliance with any other countries for which they want to do business. Meeting the regulations of every point along the supply chain is necessary for both the manufacturer as well as the logistics provider who is transporting the product, but what is the best way to achieve this?
USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
In September, 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.
Getting Particular About Particulates: How Can You Avoid Becoming The Next Recall?
While there is much speculation about why there has been such an increase in FDA recalls due to the presence of particulate matter in injectables—aging equipment, cleaning deficiencies, discrepancies between regulators, and the list goes on—what companies need to worry about most is how to protect their product and the patient by avoiding this issue altogether. But how?
Tools for the Design of Vaccines to Help Reduce Clinical Failure
If you are involved in the pharma industry, then you are interested in saving lives. In the area of preventative medicine, therapeutic vaccines have proven to have a tremendous impact on the ability to save millions of lives. Similar to pharmaceuticals, vaccine development can take over 10 years and less than 10 percent of candidates reach commercialization. Reducing the cost of failure and increasing the chances of clinical success for vaccines is beneficial to both the pharma industry and those being treated for or protected from disease.
Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert
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.
GSK Discusses The Transformation Of Biopharmaceutical Manufacturing: Single Use Is Only Part Of The Strategy
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.
BPI Offers A Look Into QbD At Genentech
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.