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 FDAnews’ newest webinar, Managing EMA Drug Process Validation Comparing and Contrasting the EMA and FDA’s Process Validation Guidelines, you and your entire office will be prepared.
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.
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