What is ICH Stability Storage Testing?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) seeks to unify international standards for testing substances or devices intended for human use.
Under ICH, the Q1A guidelines focus on testing the stability of a drug, substance, or device in storage. Specifically, it aims to determine the changes in a drug or device caused by environmental factors like temperature, humidity, and light. ICH stability storage testing is an essential component of product development and ensures that drugs and devices are safe and fit for purpose when they reach the patient or customer. Regulatory bodies require ICH testing before awarding approval and failure to comply poses huge risks to both patients and companies. ICH stability storage testing is a long and expensive process with high initial investment requirements. By outsourcing their ICH testing needs to Sampled, companies can benefit from reduced costs and collaboration with a team of seasoned experts.
Why Use Sampled’s ICH Stability Storage Testing Service?
No Capital Expenditure
ICH stability storage testing requires high upfront capital expenditure. This includes the possible purchase of new buildings, a monitoring service, data analysis experts, cleaning logs, retesting facilities, an on-call team, and service contracts for repairs and maintenance. By outsourcing to Sampled, you replace this capital expenditure and trouble with a monthly operational fee and can rest assured that your trial is in expert hands.
Outsourcing simplifies budgeting and contingency planning while providing greater flexibility. For example, if your trial fails halfway through, you can cancel early and start again after reformulation.
At Sampled, our staff are experts in ICH Q1A requirements and are ready to help you design your trial protocol. We are well versed in standard ICH testing but also offer bespoke protocols to better suit our clients’ needs. We provide a highly consultative service and see ourselves as our client’s partner rather than their supplier. For instance, a common pitfall of stability testing is not using enough spare samples. Insufficient spare samples can mean the trial must be restarted if something goes wrong, which wastes time and resources. We were the first global company to offer an outsourced ICH stability storage service, so we’ve seen it all. By outsourcing to Sampled, you benefit from our vast wealth of experience and expertise.
Facilities and Licenses
We have the facilities and licenses to perform any ICH stability storage service our clients may need as well as robust security systems to ensure your trial is safe. We are MHRA IMP cGMP licensed for goods and services, WDA and CTSA approved. We offer a disaster recovery service, which means we are ready to receive and store your samples in case of fire, flood or the grid goes down. Our on-call team can handle any emergency no matter when. This means you won’t need to cancel family plans or holidays if the worst should happen.
ICH Stability Storage Applications
We serve a wide variety of clients across the life science, medical device, BioTech, pharmaceutical, and cosmaceutical sectors. We are equipped and licensed to store a nearly infinite variety of drugs, cosmetics, substances, and devices.
Some applications of our ICH stability storage service include:
- Drug testing
- Clinical trials
- Cosmetics testing
- Nutraceutical testing
- Medical device testing
- Drug discovery
- Research studies
How Does ICH Stability Work?
ICH Q1A Guidelines
ICH is a set of guidelines for providing evidence on the quality of a substance or device for human use. Within the ICH, Q1A guidelines provide stability testing of new drug substances and drug products.
Pharmaceuticals deteriorate over time under environmental factors like temperature, humidity, and light. For a given drug or device, Sampled’s ICH stability storage service allows clients to define:
- Recommended storage conditions
- Retest time
- Shelf life
- Mean kinetic temperature (MKT)
MKT defines the effect of temperature fluctuation on the perishability of a drug substance over time. ICH provides guidelines on determining the four parameters above within five climatic zones.
Studies are typically performed along three times scales and usually within Zone II:
- Longterm: 12 months
- Intermediate: 6 months
- Accelerated: 6 months
- Performed at 40°C and 75% RH, provides earlier results at lower cost
|Relative Humidity (RH, %)
|Hot Humid Tropical
Reference and Retain Samples
Retain samples represent a specific batch and are used to verify batch integrity in case of downstream issues such as contamination.
Reference samples allow the client to check a sample or reagent from a specific batch, often to ensure compliance with market authorization.
Thermal Cycling Testing
Thermal cycling testing aims to mimic the temperature fluctuation experienced by a drug as it traverses the supply chain from production to consumer. This includes temperatures experienced during shipping, shelf life, and storage in the customer’s home.
What Are the Input Requirements for ICH Stability Storage?
At Sampled we can perform ICH stability storage testing on a huge array of drugs, substances, medical devices, and cosmetics. The input requirements depend on what the client wants to test.
This includes but is not limited to:
- Bulk pharmaceutical chemicals
- Medical devices
Find out more about our ICH stability storage service
Looking to perform ICH stability storage testing but are worried about the upfront capital expenses? Get in touch with one of Sampled’s experts today to find out how we can meet all of your ICH stability storage needs.