Read, Learn, Innovate: Top Blog Posts from April 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
ISPE is dedicated to keeping our members up to date on the latest news and resources about COVID-19 and the ways the pharmaceutical industry is adapting to ongoing developments. One valuable resource is the Food and Drug Administration’s (FDA) question-and-answer-post, Manufacturing, Supply Chain, and Drug Inspections (COVID-19), which provides guidance on how to implement manufacturing and site changes as well as reporting to an application.
As we continue to monitor the COVID-19 pandemic, our thoughts are with our Members and those impacted. We recognize that the ever-changing impact of this novel virus is disruptive to so many aspects of our personal and professional lives. We are not insulated from these disruptions; but I want to assure you that ISPE is here to support your knowledge and connectivity needs.
A panel of industry experts from a variety of disciplines discussed key challenges to the global pharma supply chain due to the current coronavirus pandemic during the “COVID-19: Pharma Supply Chain Security and Robustness During a Global Pandemic ” ISPE webinar on 2 April 2020. More than 660 attendees from 64 countries heard both strategies as well as predictions about future changes to the supply chain for pharma during the 60-minute webinar.
Commercially available Advanced Therapy Medicinal Products (ATMPs) are now a reality and significant, rapid growth is expected for new treatments and applications in the clinical development pipeline. By some estimates, from 2014 to 2018, the number of initiated clinical trials grew 32% globally – totaling 1,028 active trials as of end of year 2018 – 92 of which were Phase III.
ISPE places the health and safety of its members, staff, and the broader ISPE global community as its top priority. As the COVID-19 outbreak continues, the ISPE Drug Shortages Initiatives Team encourages everyone to follow the available safety and health guidance applicable to your communities. Additionally, ISPE has a long-standing commitment to preventing and mitigating drug shortages.
The topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have...
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...