pharmaceutical Stability Storage facility
ICH Stability Storage
Roylance Pharma offers all conditions as defined in ICH, Q1A and Q1B guidelines for the four main world climatic zones as well as any custom conditions you may require.
Roylance Pharma specialises in the simulation of environmental conditions and provide a trusted outsourced environmental testing service in our multi-point validated chambers which are traceable to UKAS and NPL via their chilled mirror unit.
Roylance Pharma can help with incorporation of Stability studies during all stages of the drug product life cycle; from early stage of the product development to late stage follow-up stabilities. We can take anything from a small 50L one off study up to any size of trial and also accommodating specific tailored requirements.CONTACT US
The Life Cycle
The life cycle can be segregated into 6 different stages:
- Stage 1: Early stage and accelerated testing with drug products
- Stage 2: Stability on pre-formulation batches
- Stage 3: Stress testing on scale-up batches
- Stage 4: Accelerated and long term testing for registration purposes
- Stage 5: On-going stability testing
- Stage 6: Follow-up studies
Controlled Environment Storage & Stability Storage At Custom Conditions
Roylance Storage’s validated and continually monitored temperature and humidity controlled chambers have backup emergency systems in place to protect the integrity of your samples at all times.
Roylance Storage can store a huge variety of products including:
- Pharmaceutical samples
- Clinical trial material
- Bulk pharmaceutical chemicals
- Medical devices
- Animal health
Roylance Storage provide a safe, secure facility for your samples:
- Dual electricity supply
- State of the art facility
- Physical on site security
- Access control throughout facility
- CCTV – monitored
- Data stored on cloud and duplicated on another continent (geo-redundant)
- Full spares package kept on site
- Independently QA approved
- ISO 9001:2015
- 21CFR PART 11 compliance
- cGMP compliant
Why choose us
Roylance Pharma are the Stability Storage specialists, whether it is out-sourcing your sample storage,
equipment, validation or a service contract Roylance Pharma have you covered!
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