Read, Learn, Innovate: Top Blog Posts from May 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
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 while remaining in compliance with all other governing codes, laws, mandates, and regulations.
Major companies were working aggressively to develop and bring to market an ever-expanding set of candidates, and of modalities, to the benefit of patients. Large suppliers innovating manufacturing technologies and analytical approaches needed to help accelerate development timelines and allow for increased flexibility in manufacturing paradigms.
The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA viruses with either single-stranded (ss) or double-stranded (ds) genomes. The approval and or under regulatory review of viral vector-based drugs are making progress in the cure and or treatment of certain ailments.
Wow! As a Founding Member of ISPE, you’ve been with the Society for 40 years! Can you provide a brief summary of your involvement with ISPE and share some of the more interesting experiences and successes you’ve had with the Society during your lengthy...
This blog is the last of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...