Articles By Trisha Gladd

  1. Pfizer Collaboration Prepares For The Future Of Flexible Manufacturing 11/20/2013

    With the landscape of the industry shifting toward the need for more flexibility, pharma companies are exploring more ways to keep pace with this demand while still keeping costs low. In a recent announcement, GEA Process Engineering, G-CON Manufacturing, and Pfizer revealed how they’re addressing this challenge — a Portable Continuous Miniature & Modular (PCMM) manufacturing collaboration.

  2. H.R. 3204 Could Emerge From The Serialization “Thunderdome” This Month – Then What? 10/25/2013

    H.R. 3204 Could Emerge From The Serialization “Thunderdome” This Month – Then What?

    What serialization deadlines should the pharma industry be preparing for? Because federal legislation would trump California law, this is the question everyone is asking. And until the Senate passes a track-and-trace bill, it will continue to be a waiting game.

  3. A Look At Pack Expo 2013 And The Future Of The Pharma Packaging Trade Show 10/1/2013

    By Trisha Gladd, editor, Pharmaceutical Online and Bioprocess Online

    This year’s Pack Expo was held at the Las Vegas Convention Center from September 23-25, and with so many experts from the pharmaceutical industry planning to attend, my expectations for the show were high. After finishing preparations for interviews, visits, press conferences, and plenty more that the show had to offer, I took off for Sin City with a packed schedule in one hand and gambling money in the other.

  4. Making Peace With Plastic Packaging: How Fear Of The Unknown Might Be Pharma's Biggest Hurdle 9/18/2013

    By Trisha Gladd, editor, Pharmaceutical Online and Bioprocess Online

    While there are plenty of advantages of using plastic packaging instead of glass, some pharmaceutical manufacturers still won’t consider it for liquid pharmaceuticals because of the long history and tradition of using glass. However, is this because it’s not a good choice for pharmaceutical packaging or is it because we just don’t know enough?

  5. A Shift In Focus: The Value Of Serialization 9/1/2013

    By Trisha Gladd, editor, Pharmaceutical Online and Bioprocess Online

    When it comes to the topic of serialization and California’s 2015 deadline, much of the discussion focuses on cost and compliance. What are the costs associated with preparing your company for California’s ePedigree Law? With a history of delays in this law, as well as a federal mandate, is preparation even necessary?
     

  6. How Active Packaging Systems Can Provide More Than Temperature Control

    With the cost of cold chain logistics expected to rise from 6.7 billion in 2012 to 10.7 billion in 2017, it is even more important for pharmaceutical manufacturers producing temperature-sensitive drugs to select the most effective packaging solution to ship their product.  

  7. A Global Look At Product Protection

    We all know that serialization deadlines are looming.  While some companies have serialization projects underway, others are still waiting to get theirs started. Whatever the situation, there are still many unanswered questions about product protection, both domestically through the Drug Quality and Security Act (DQSA) and internationally through each country's regulations, and some of these answers are very hard to find (while others are still to be determined).

    I recently sat down with two lead serialization consultants from Enterprise System Partners, a global consulting and project engineering company specializing in serialization and MES within the life science industry, to discuss many of the questions they’re receiving from their customers. Liam O’Riordan and Linda Murphy provided some clarity around certain aspects of the legislation and what it means both in the US and globally.

  8. Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    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.

  9. 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?