Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 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.
ICH Q12 is another quasi-management-based regulatory guideline.1 In a nutshell, the industry should expect additional confusion and more work from a vaguely defined, potentially duplicative system that will likely further inhibit the industry from achieving excellence. In order to achieve excellence, the lifecycle product management concepts described in ICH Q12’s title need to be a lot more than retrospective change control.
I have been going to the ISPE Aseptic Conference since 2008 and the overwhelming response is that this is the best technical conference that ISPE hosts. The amount of learning, networking, and understanding that you can get at this conference is unparalleled. There are some valuable lessons that can be had at the Aseptic Show.
Biopharmaceutical manufacturing faces many new opportunities as we enter this decade. ISPE is returning to Boston for the 2020 ISPE Biopharmaceutical Manufacturing Conference on 1-3 June 2020, bringing you once again an innovative conference, followed by the 2020 ISPE Continuous Manufacturing Workshop and relevant training classes 4-5 June 2020.
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 pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational efficiency and long-term success. From reducing carbon emissions to enhancing workforce safety, companies are aligning their practices with sustainability goals. The 2025 ISPE Annual Meeting & Expo is the ideal platform to exchange ideas and...
The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.