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.
Ensuring delivery of effective medicines requires an agile business strategy effectively utilizing technology to:
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.
Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...