Pharmaceutical manufacturers must establish the stability of their drug products towards light. But what makes a drug molecule or formulation unstable to light, and how can appropriate protection be given? Find out in this guest post from Dr. Mark Powell on photostability testing.
This back to basics Q&A article on stability storage and testing has been put together by our expert team.
Do you have a disaster recovery plan to cover a chamber breakdown or emergency failure in your stability storage process? What happens when unforeseen events interrupt your stability study? The loss of samples that have been in stability storage due to a chamber breakdown or emergency in your sample storage process could represent a critical … Continued
We have recently increased the capacity of our facility at Q1 Scientific, with the introduction of Stability Rooms #30 and #31.
Q1 Scientific Shortlisted for 3 National Awards
Q1 Scientific were delighted to feature in Waterford News and Star’s recent Life Science, Technology and Manufacturing supplement.
Installing Stability Storage Chambers – Factors to Consider Q1 Scientific is a stability storage facility, providing industry-leading temperature-controlled storage. Over the years we have installed over 30 walk- in stability chambers along with numerous types and sizes of reach-in units.
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
“A site that carries out storage of stability samples is not required to hold a GMP certificate for this activity in Ireland”
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