The rapidly accelerating demand for combination products continues to drive technological advances in merging product types. However, the convergence of pharmaceuticals with medical devices brings a host of new challenges in stability studies and storage. At a high level the FDA defines combination products as “therapeutic and diagnostic products that combine drugs, devices, and/or biological … Continued
How do you set a retest period for a drug substance or shelf life for a drug product? How can extrapolation be applied to propose a retest period or shelf life for a drug product that extends beyond the period covered by real-time stability data? In this article, we outline how we can assist you with … Continued
Cold chain logistics are a constant challenge for the healthcare supply chain. With the roll out of COVID-19 vaccines the whole pharmaceutical supply chain is facing a huge and complex task.
As the team at Q1 Scientific adjusts to the new regulations, we have created this guide to show how we can support UK companies and testing laboratories with moving samples after Brexit to and from Q1 Scientific.
Do you need vaccine storage facilities at ultra-low freezer temperatures? Having reliable ultra-low freezer storage is essential for vaccines and temperature sensitive pharmaceutical products.
What happens if you need more stability storage space? See our simple tips for increasing your stability storage space.
Based on our experience providing stability storage this article provides our top 5 tips for better stability monitoring.
The ICH Q1B guideline is the harmonised effort to standardise photostability testing on new pharmaceutical drug substances and drug products.
The brand new ‘Science of Business’ podcast series is sponsored by Q1 Scientific. Created in Ireland, this series shares the insights, career journeys, the start-up phase and behind the scenes stories from one of Ireland’s most successful business sectors.
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