Read, Learn, Innovate: Top Blog Posts from February 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant with the law and the regulatory guidelines. All this is influenced by new methods and technology innovations, either process- or technology-based.
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.
Today we are facing a new type of challenge with an undefined period of impact. Many of your companies have already started to engage your BCP and are finding gaps due to the unique level of impact that the virus imposes. As an Industry we are all impacted, and it is a prime time to collaborate and help one another to face this challenge. As such we welcome you to participate in this blog to discuss how you have been working to prepare for this threat.
The GAMP® Global Leadership strongly supports a patient-centric and quality risk-based approach to the assurance of computerized systems. Explore the incorporation of innovative computerized technologies and approaches that advance pharmaceutical production to support product quality, patient safety, and data integrity.
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...