Pharmaceutical Stability Storage and Testing

Exova has successfully completed many stability studies for pharmaceutical and medical device companies worldwide. With extensive capacity over several locations, in GMP-compliant laboratories, a complete storage and testing service can be provided. Alternatively, Exova can supplement clients’ own in-house resources. Our team is fully conversant with ICH Q1A(R2) Guideline for new drug substances and products. ICH Q1B Photostability testing is also a core service.

Storage Capabilities

Exova offers a full range of monitored temperature, humidity and light stability storage conditions for ICH Guidelines Q1A and Q1B, covering requirements for Climate Zones I to IV. In addition, there is the flexibility to store samples at other temperatures and humidity’s including 50°C and 60°C for degradation studies and <-70°C for biologicals.

Exova’s stability chambers are mapped, monitored and alarmed with 24-hour call-out support and back-up power supply, to ensure integrity of all stability samples. Study-specific protocols are established in conjunction with our clients, and supported by comprehensive method development and validation services.

Testing Capabilities

Stability testing is performed by highly experienced, well-qualified analysts. Services include assay, impurity and degradation product monitoring and additional formulation-specific chemical and physical tests. This service is provided for all stages of drug development, from early forced degradation stressing studies, to development of stability-indicating assays, through clinical and finished product programs. Project scope can vary from small one-off studies to major partnerships where the resources of Exova can make the difference in delivering clients’ studies on time to meet market requirements.

Exova aims to develop a long term relationship with all customers and can offer a high quality service to meet your needs which includes:

Additional Storage Services

Stability Storage Conditions

Stability Storage in accordance with ICH Guideline Q1A (R2)/Q1B (controlled temperature, humidity and light)

ICH Conditions available (covering Climate Zones I to IV):

 

Condition

-20°C ±5°C

5°C ± 3°C

25°C/40%RH

25°C/60%RH

30°C/35%RH

30°C/65%RH

30°C/75%RH

40°C/75%RH

Photostability

 

Additional conditions available:

 

Condition

= -70°C

50°C ± 2°C

55°C ± 3°C

60°C ± 3°C

30°C/70%RH

45°C/75%RH

 

 

• Accelerated stress studies at high temperatures and humidity’s
• Flexibility for additional temperature/humidity conditions – available on request
• Multiple storage chambers available at each main ICH condition (for business continuity purposes)
• 24-Hour continuous monitoring and recording of conditions
• Alarms linked to 24 hour call-out
• Back up power to stability chambers and monitoring system

 

Strategic storage option for samples (storage within a separate stability chamber at the same condition for business continuity purposes)

 

• Protocol writing and final study report
• Deviation assessment
• Home Office Licensed facilities
• Potent handling facilities

 

Additional Storage Services:

Reference Material Storage/Distribution

It is important to ensure that a single, valid, certified reference standard is used by all laboratories performing work on an API or product, where the work involves quantitative or qualitative analysis relative to a reference standard.

Exova offers a storage, administration and distribution service for reference standards and related substances (chromatographic markers, impurities, degradation products etc.), whereby bulk and dispensed supplies are stored, re-validation schedules are managed, and aliquots are shipped to testing/manufacturing sites, as required.

Reference materials are stored in continuously-monitored, controlled-environment chambers, qualified as for stability storage.  Aliquots for distribution are dispensed in GMP-compliant laboratories and are shipped to testing/manufacturing sites under controlled conditions.  Exova also provides a full characterisation/re-validation analysis service for reference materials.

Storage Conditions Available:

<-70°C              -25°C to -15°C               2°C to 8°C         15°C to 25°C

GMP Retained Sample Storage

Exova provides a storage service for ‘retention samples’ as defined by EU Guidance on Good Manufacturing Practice.  Retained samples are stored in continuously-monitored, controlled-environment chambers, qualified as for stability storage.

Storage Conditions Available:

-25°C to -15°C               2°C to 8°C         15°C to 25°C