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Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?
The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.
The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?
The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.