Services Archive - Q1 Scientific

Stability Storage

Pharmaceutical Storage

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).

Storage Conditions

Q1 Scientific offers state of the art environmentally controlled and monitored storage facilities across the full range of temperatures and humidities.

Protect and leverage your valuable biological sample assets with quality assurance by outsourcing to a leader in comprehensive scientific sample asset storage & management

Q1Scientific will help you develop a biological sample management strategy, organize your portfolio and secure your inventory. Our quality operations offer complete short-term and long-term storage solutions. We store, at multiple temperatures, any biological sample in various phases of clinical trial testing, in addition to tissue and many other sample types listed on this page.

Thermal Cycling

Thermal 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)

Disaster Recovery

Q1 Scientific can provide a primary or contingency storage solution with the option of a disaster recovery capability if required.

We have a disaster recovery procedure in place to cover any emergency transfer of samples from clients from individual batches to entire chambers. Clients can be assured that should one if their own stability chambers go down, Q1 Scientific can take the affected samples to avoid significant interruption to client stability studies

Sample Management

Q1 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

Photostability

The ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.

Photostability Guidelines

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.