Did you know EU and US regulations mandate Quality by Design (QBD) dossiers and the EU GMP regulations require Innovation and Continuous Improvement? I’m sure you agree but regulations should not drive your innovation.
GMP applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation. However the Pharmaceutical Quality System can extend to the pharmaceutical development lifecycle stage as described in ICH Q10, which while optional, should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.
Why have the regulators changed this?
Well historically, there has been a perceived ‘risk’ of regulatory action that stifled new ideas and innovation. The regulators have provided us a practical pathway to innovate, but in a safe manner.
If there is an unwillingness in your organisation to deploy new technology or introduce new skills, we now have a framework to guide us. PharmOut are certainly at the cutting edge of guiding a number of companies through these programs, and are passionate about innovation with a greater assurance of quality. This is the driving force behind Quality by Design (QBD).
If you are looking for some practical tools to help drive your companies vision of how to innovate and modernise, then this free QbD workshop might help. This event is being facilitated by PharmOut and hosted by the AIGroup with MTP Connect, who form part of the Australian Government Department of Industry, Innovation and Science. Half day workshops will be offered in Adelaide, Brisbane, Melbourne and Sydney.
Innovation Dinner – Melbourne – 15th November 2016
PharmOut prides itself in offering cost effective, innovative, yet practical solutions to our clients, building long-term partnerships and being the company that they can trust. We have become the largest and leading QA/GMP consultancy in Asia-Pacific and are respected as the industry thought leaders with fresh innovative ideas in Quality Assurance, GMP and facility design. These ideas, thoughts and advice is generously shared in our blogs, white papers and in various forums, and we are never too busy to help.
As part of this innovative tradition, we celebrate the end of every year with a dinner in Melbourne. This year is no different, and we invite leading thought leaders and practitioners to attend. This year we are fortunate to have Simon Corah from Growth Mantra and Cathie Reid from Icon Pharmacy Group to speak to us.
If you would like to know more, visit our website.