Read, Learn, Innovate: Top Blog Posts from October 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
What About the Environmental Impact of Single-Use Technology on Sustainability?
The environmental impact of “single-use plastics” has become a hot topic of societal and political debate. Despite the many technological advantages and innovations that plastic has enabled, it is now under closer scrutiny, especially those massively used in consumer market (plastic bottles, cutlery, straws, packaging, etc.).
Meet Sanofi – 2020 Facility of the Year Award Winner for Facility of the Future
Sanofi is the 2020 Facility of the Year Award Winner for Facility of the Future for their Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, Massachusetts.
How Should We Handle Requirements in a GxP Compliant Agile Software Development Process?
Successful delivery requires ensuring we build the right system that is fit for the intended use, not just ensuring we build the system right. Traditionally, documented Requirements are termed as the “User Requirements Specification” (URS) within pharmaceutical projects and are often interpreted as a key “must have” document containing the full set of requirements before any other work is done, regardless of what project approach is used.
Successful Process Characterization – A How-to-Guide in 7 steps
Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process validation, statistical approaches and the need of statisticians in a multi-disciplinary team is mentioned no less but 15 times.
ISPE Responds to PIC/S: Additional GMP for ATMPs & Biologics Recommendations
ISPE was selected as one of a limited number of focused stakeholders to provide comments on nine questions posed by PIC/S on the draft GMP Guide Annexes 2A for Advanced Therapy Medicinal Products (ATMPs) and 2B for Biological Medicinal Substances. ISPE provided comments and recommendations in January 2020.
