From our 20,000 sq ft cGMP facility in Belgium, we offer stability storage conditions to meet ICH and non-ICH requirements.
Validated for long- and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).
Read MoreThermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment and subsequent use (ICH Q1 A 2.1.7)
Read MoreValidated for long- and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).
Read MoreQ1 Scientific offers a complete stability study sample management service. The Q1 Scientific QMS is set up to manage stability samples from the initial protocol development through to defining pull points and delivering samples to the laboratory for analysis. Clients are provided with full visibility of actual monitoring data and details on all their samples on stability
Read MoreThe ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.
Testing is carried out on a single batch of material selected. Whether studies should be repeated depends on the photostability characteristics determined at the time of initial filing and the type of variation and/or change made. The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. It does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guideline.
Read MoreNeed ultra low storage? Ensuring the integrity of ultra low temperature sensitive medicine and pharmaceutical products is important.
Q1 Scientific is the ideal solution for storing your products at ultra low temperatures down to -80˚C.
At our facility we offer all commonly used conditions for biological or vaccine storage:
Join us to hear the latest trends and best practices in stability studies and product development
Killashee Hotel, Naas, Co. Kildare, Ireland
Wednesday 18th October 2023
Compliance with GMP is a mandatory aspect of pharmaceutical manufacturing, the ultimate goal being the safe-guarding of patient health and the provision of high quality and efficacious medicines. Read more…
Complete stability sample
management service.
Unique stability
study calendar.
Remote sample
access.