Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.
It goes without saying that reflecting on the last few years, immense progress has been made in the biopharmaceutical industry. We have seen an industry prioritising collaboration and innovation, combined with a healthy competitive spirit, brought new technology to reality, and achieved milestones in twelve months that would previously have taken a decade.
The exponential increase in demand to manufacture therapeutics including vaccines triggered by the pandemic has stressed the supply chain for single-use products.
It would be easy to say that the pandemic has driven dramatic growth for CDMO companies, as more pharmaceutical firms seek to outsource. Really though, the trend started much earlier, with many CDMOs having put their massive expansion plans in place a year or more before the pandemic took hold.
The ISPE South Central Chapter recently hosted their Inaugural South Central Chapter Education Seminar from College Station, while live-streaming in Austin, Houston, Dallas-Fort Worth Area (DFW), and The University of Oklahoma. Each city hosted an in-person networking dinner followed by the sessions on Vaccine/Gene Therapy Manufacturing and Writing User Requirements Specifications.
mRNA is back at the 2022 ISPE Biotechnology Conference. Last year we learned from major key players about their journey to develop first time mRNA vaccines against COVID-19 and build manufacturing capacity for billions of doses in less than one year. In 2022 we are revising the relevance of mRNA technology and widening the view beyond the COVID vaccine.
ISPE’s ICH Q12 Implementation Team, a technical team under the auspices of ISPE’s Product Quality Lifecyle Implementation (PQLI)® committee, recently worked with Health Canada (HC) to develop and...
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Quality Risk Management (QRM) guidance was signed off by ICH in November 2005 as one of a suite of guidelines alongside Q8, Pharmaceutical Development, Q10, Pharmaceutical Quality System and later, Q11, Development and Manufacture of Drug Substances, which describe the science- and...
ISPE’s Analytical Method Strategy/ICH Q2(R2) & Q14 team, a working group within ISPE’s Product Quality and Lifecycle Implementation (PQLI)® Committee, to lead ISPE’s comments on the ICH documents to regulatory authorities.
