HPRA & FDA Mutual agreement between EU and US
Multual Recognition Agreement (MRA) HPRA / Ireland has been listed by the US Food and Drug Administration (FDA) as part of the mutual recognition agreement between the EU and the US
Tag: stability
HPRA Update on regulatory oversight of outsourced storage of stability samples
“A site that carries out storage of stability samples is not required to hold a GMP certificate for this activity in Ireland”
Stability testing requirements for Pharmaceuticals and Medical Devices
Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued