Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
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.
This Blog focuses on the topic of infrastructure, covering recommendations made by an FDA / industry team linked to the FDA Case for Quality initiative, and the GAMP re-examination of approaches to infrastructure.
The pharmaceutical industry’s work on developing treatments and vaccines for COVID-19 (novel coronavirus) is moving forward, including these recent developments:
One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.
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.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...