Stability Storage

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.

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Sampled’s ICH-Compliant Stability Storage

Our ICH stability storage service provides controlled, compliant storage for investigational products and therapies under validated environmental conditions. We support stability programmes by maintaining samples in accordance with ICH guidelines, generating high-integrity environmental data to support regulatory submissions and product development. We offer:

• All conditions as defined in ICH, Q1A for the main world climatic zones as well as any custom conditions
• ICH, Q1B photostability testing
• Bespoke stability conditions, flexibly configured to meet specific product, protocol, or customer requirements
• Robust disaster recovery and sample transfer solutions to ensure study continuity in the event of unexpected disasters

Our services give you reliable information enabling you to progress with regulatory processes or make informed product development decisions with confidence.

Stability Testing ICH Q1A

Under the ICH, the Q1A guidelines focus on testing the stability of a drug, substance, or device in storage in different climatic zones. ICH Q1A (R2) stability testing of new drug substances specifically aims to determine the changes in a drug or device caused by environmental factors like temperatures, humidity, and light.

Regulatory requirements demand 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 ICH testing, you benefit from reduced costs and an expert-led service.

We support stability studies during all stages of the drug product life cycle; from early stage development to late stage and post-registration follow-up. Our services are fully scalable from small one-off studies to large multi-batch clinical and commercial programmes, with the flexibility to accommodate bespoke and protocol-specific requirements. We cover the following stages of study lifecycles:

• Stage 1: Early development/accelerated feasibility
• Stage 2: Pre-formulation/formulation development
• Stage 3: Stress studies for degradation pathways
• Stage 4: Registration stability (ICH Q1A core)
• Stage 5: On-market/on-going stability (ICH Q1A + Q10)
• Stage 6: Post approval commitments/variations

Expert-Driven ICH Stability Processes Ensure Compliance

Gold-Standard Storage

Pharmaceuticals deteriorate over time under environmental factors like temperature, humidity, and light. For given drug products or devices, our ICH Q1A stability storage service allows clients to define:

• Recommended storage conditions
• Retest time
• Shelf life

Our infrastructure supports a range of testing conditions, including:

• 25 ºC/60%RH
• 30 ºC/65%RH
• 30 ºC/75%RH
• 40 ºC/75%RH
• 50 ºC, 55 ºC
• Bespoke stability conditions, flexibly configured to meet specific product, protocol, or customer requirements

Our temperature-controlled stability monitoring system generates high-integrity environmental data to support stability studies, including long-term and cold storage programmes. This data enables assessment of shelf life, efficacy, and safety under defined storage conditions such as temperature and humidity. Our comprehensive multi-point validated chambers are traceable to national standards and we have backup emergency systems in place to protect the integrity of your samples at all times. Our dedicated on-call team is on hand to respond to any breakdown or emergency incidents to ensure product integrity is maintained.

Reference and Retain Samples for Robust Testing

Retain samples represent a specific batch and are used to verify batch integrity in case of downstream issues. These samples allow you to verify a sample or reagent from a specific batch, typically to ensure compliance with market authorisation.

We provide ICH stability testing services for a diverse range of pharmaceuticals, medical devices, and cosmetics, ensuring compliance with regulatory requirements. This can include, but is not limited to:

• Pharmaceuticals
• Bulk pharmaceutical chemicals
• Cosmetics
• Nutraceuticals
• Vaccines
• Medical devices

Ensure Temperature Resilience with Thermal Cycling Testing

Thermal cycling testing aims to simulate the high temperature fluctuations experienced by drug products as they travel through the supply chain from production to the consumer. The thermal cycle includes temperatures experienced during shipping, shelf life, and storage in the customer’s home.

Disaster Recovery

We offer a robust disaster recovery solution for your materials. This service can be tailored to your specific needs with various options available at purpose-built facilities, located with convenient access to major motorway networks across the UK. Our 24/7/365 on-call team manages receipt and controlled storage to ensure product integrity is maintained in the event that your internal infrastructure is disrupted or unavailable.

QP Oversight and Certification

Our Qualified Person (QP) ensures that imported medicinal products meet all applicable UK regulatory requirements. We also perform full QP certification for IMPs from third party countries.

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Photostability Testing

The ICH Q1B guidelines focus on photostability testing of new drug substances and products upon exposure to light using calibrated UV and lux sensors. Photostability testing is an essential component of product development and is mainly used for the submission of registration applications for new molecular entities and associated drug products. Photostability, along with thermal cycling and stability storage, is required for regulatory alignment. Failure to accurately perform photostability testing can have serious consequences for consumers and companies.

Photostability ICH Q1B Guidelines

ICH Q1B guidelines establish the requirements for providing evidence on the quality of a substance or device for human use. The ICH Q1B guidelines provide instructions on photostability testing of new pharmaceutical drug substances and products across different measurement ranges. Tests are typically performed in batches and are repeated if any changes are made to a product.

Expert-led Light Exposure Source Decisions

There are two options for the light source used in stability testing of new drug substances and products:

• Option 1: Exposure to any source similar to D65/ID65 emission
• Option 2: Exposure to a cool white fluorescent and near ultraviolet lamp

Either can be used. We use option 2 because it offers the fastest turnaround time for our clients.

Comprehensive Photostability Testing Procedures

Confirmatory studies must prove sample light exposure, providing an overall illumination of not less than 1.2 million lux hours and an integrated near UV energy of not less than 200 watt hours/square metre.

Calibrated lux and UV sensors with appropriate spectral response are used to ensure that the above parameters are met. A dark control, consisting of a duplicate sample wrapped in aluminium foil, is used for comparison. The exposure takes 5-14 days for the above parameters to be achieved. Once they have been achieved, both samples are removed, the test sample is wrapped in foil, and both are sent back to the client for testing.

We regularly replace our bulbs to ensure optimal light output and consistent irradiance, maintaining the integrity and reproducibility of photostability studies in line with ICH Q1B requirements, while enabling efficient and predictable study timelines. We can perform photostability testing on a huge array of drugs, substances, medical devices, and cosmetics. This includes but is not limited to:

• Pharmaceuticals
• Bulk pharmaceutical chemicals
• Cosmetics
• Nutraceuticals
• Vaccines
• Medical devices

Save Costs and Ensure Compliance by Outsourcing Photostability Testing

Optimise Your Resource Efficiency

Most companies perform photostability testing once every few years, which means their photostability equipment is mostly unused. Photostability instrumentation is expensive, occupies space, and requires regular validation, testing, and servicing. Outsourcing means you only pay for photostability facilities when needed.

Leverage Expertise for Accurate and Compliant Photostability Testing

We serve hundreds of clients and perform photostability testing regularly. This means our expert team conducts testing that is up-to-date with new regulations, using validated instrumentation. By outsourcing, you don’t need to worry about expertise or equipment. We handle everything.

We serve a diverse range of clients across the life sciences, medical device, biotech, pharmaceutical, and cosmeceutical sectors. We are equipped and licensed to test a nearly infinite variety of drugs, cosmetics, substances, and devices.

Some applications of our photostability testing service include:

• Drug testing
• Clinical trials
• Cosmetics testing
• Nutraceutical testing
• Vaccines
• Medical device testing
• Drug discovery
• Research studies