BioPhorum members have come together to reflect on standards applied to the manufacture of biologics for the Russian Federation market. They have considered the current state described in the Russian Pharmacopoeia and regulations, as well as forthcoming changes in the...
Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant...
