The first step in the assessment process is for a program or department to define their mission and learning goals. Assessment is an on-going process, and can be thought of as a cycle. A new program ...
A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established. The pharmaceutical regulatory landscape and pharmaceutical ...
Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.