EMA Calls for Documentation of Biologic Manufacturing Processes
Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says.
Drugmakers should provide further details of in-process testing and criteria as the product moves forward and they gain greater process knowledge, according to a new guideline on quality documentation for investigational biologics.
The guideline advises sponsors on documentation requirements for the biological, chemical and pharmaceutical quality of experimental biologics, to be included with a request for clinical trial authorization in the investigational medicinal product dossier.
While the FDA has its own policies and focus areas for process validation, the EMA goes about it another way. If the EMA inspectors visited tomorrow, would you pass or fail?
With this Wednesday’s webinar, you’ll get a side-by-side commented comparison of the 2012 EMA Process Validation Draft Guideline vs. the FDA 2011 Process Validation Final Guidance. This three-column worksheet shows the similarities and differences between FDA and EMA approaches at a glance.
The best news — you and your colleagues will participate from the comfort of your own office. No planes, no hotels, no precious time away from work and family — just 90 minutes of solid, interactive learning via the Web. Why wait, register today!
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!