cGMP Pharmaceutical Stability Studies

GMP pharmaceutical stability studies and ICH storage services supporting your drug product development, commercial stability studies, batch release and quality control testing

Pharmaceutical stability studies are an essential component of the development and lifecycle of pharmaceutical products, in particular, supporting development and IND / NDA submission activities. They allow evaluation of active pharmaceutical ingredient (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.

It is important that you select an experienced stability study outsourcing partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real-time, accelerated or forced-degradation study requirements. Stability testing can present significant analytical hurdles, with specialised knowledge required to develop and validate stability indicating methods and perform analysis of leachable substances which migrate from pharmaceutical packaging into the product.

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage which are fully controlled and monitored with back up chambers at each site. All sites have 24-hour alarm systems with dedicated on call teams to react to the excursions from storage conditions. Our stability teams provide professionally managed Good Manufacturing Practice (cGMP) stability programs for even the most complex of dosage forms, APIs or product types including orally inhaled and nasal drug products (OINDP), biopharmaceuticals, consumer healthcare, medical devices or vaccines. We also offer a responsive and bespoke stability contingency and disaster recovery storage service to help you mitigate the risks associated with costly stability trials.

GMP Stability Services:

  • cGMP registration stability programs
  • Protocol design and program management
  • Development and validation of stability indicating methods
  • Stability testing for APIs, clinical trial materials, formulated products
  • Tailored reporting (timepoint and final reports)
  • Temperature cycling, freeze-thaw and shipping studies
  • Stability contingency and disaster recovery storage
  • Forced degradation testing 
  • Real-Time stability testing
  • Accelerated stability testing
  • Formulation stability testing
  • Biologics stability studies
  • Specialist expertise for OINDP stability programs
  • Extractables / leachables

ICH Stability Conditions Available
We have an extensive range of ICH stability conditions available to our customers across the Intertek network:

  • 21ºC / 45% RH
  • 25ºC / 40% RH
  • 25ºC / 60% RH
  • 30ºC / 25% RH
  • 30ºC / 35% RH
  • 30ºC / 65% RH
  • 30ºC / 75% RH
  • 40ºC / 75% RH
  • Cabinets 50 ºC, 57 ºC, 60 ºC
  • Storage at 2-8ºC, -20ºC, -40ºC, -80ºC
  • Photostability (ICH Options 1 & 2)
  • Specialised conditions
  • Freeze / thaw cycle tests

Stability Testing and Analysis
Our analytical laboratory network provides development and validation of stability indicating methods through state-of-the-art technology to identify and quantify degradation products. Routine time point testing includes the usual tests such as assay and impurity analysis, dissolution, moisture, hardness, friability and disintegration. Intertek’s scientists have specialist knowledge for OINDP testing as part of a stability program including measurement of particle or droplet size, providing data critical to understanding the size distribution of the delivered formulation and the delivery of the drug from the device. With unrivalled know-how in extractables and leachables studies, we can ensure that the complete product and packaging system demonstrates sufficient stability and protection over the relevant lifecycle of your product.

Your Pharmaceutical Stability Program Partner
With over 20 years’ experience in conducting stability studies integrated with a comprehensive understanding of the latest developments in regional, country and ICH stability study guidelines, we offer a truly flexible stability outsourcing partnership with integrated storage and testing capability which allows you to focus on your core business objectives. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards for your pharmaceutical products. 

Need help or have a question? +1 800 967 5352

Need help or have a question?

+1 800 967 5352
+1 908 534 4445 x600
+44 161 721 5247
+41 61 686 4800