ICH Pharmaceutical Stability Testing and Storage

Stability testing for pharmaceutical products and ICH storage outsourcing services for drug substances or drug product stability testing supporting development with efficient study management, standard or bespoke storage conditions to meet your real-time, accelerated or forced degradation stability study requirements

ICH pharmaceutical stability testing is an essential part of drug product development, in particular, supporting IND/NDA submission activities. Stability testing of drug substances and products 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.

Selecting an experienced stability study service partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real-time stability testing, long-term, intermediate, accelerated stability studies, forced-degradation, photo-stability, in use or follow-up stability testing trial requirements is key to success. Stability testing can present significant analytical hurdles and specialised knowledge is 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, covering all ICH stability conditions. These are fully controlled and monitored with back up chambers at each site. All ICH stability testing 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) ICH stability studies 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 stability storage outsourcing and stability contingency storage services to help you mitigate  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 of active pharmaceutical ingredients and finished pharmaceutical products, clinical trial materials, formulated products
  • Tailored reporting (timepoint and final reports)
  • Temperature cycling, freeze-thaw study and shipping studies
  • Stability contingency and disaster recovery storage
  • Stability storage outsourcing
  • Forced degradation testing 
  • Real time stability testing
  • Long term stability testing
  • Intermediate stability testing
  • Accelerated stability testing
  • In use stability testing
  • Follow-up stability trials
  • 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 pharmaceutical stability storage stability conditions spanning the ICH climatic zones and also bespoke storage capabilities:

  • 21ºC / 45% RH
  • 25ºC / 40% RH
  • 25ºC / 60% RH
  • 30ºC / 25% RH
  • 30ºC / 35% RH
  • 30ºC / 65% RH
  • 30ºC / 75% RH
  • 40ºC / 75% RH
  • 40ºC / NMT 25%RH
  • Cabinets 50 ºC, 57 ºC, 60 ºC
  • Storage at 2-8ºC
  • ULT storage -20ºC, -40ºC, -80ºC
  • ICH Photostability (ICH Q1B Photostability Options 1 & 2)
  • Specialised conditions
  • Freeze/thaw temperature cycling tests

Stability Testing of Pharmaceutical Products
Stability testing can present significant analytical hurdles and specialised knowledge is required to develop and validate stability indicating assay methods and perform analysis of leachable substances which migrate from pharmaceutical packaging into the product.

Following ICH stability testing guidelines, our analytical laboratory network provides development and validation of stability-indicating methods utilizing a range of technologies 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 expertise in OINDP testing for stability including particle or droplet size to provide data to drive understanding of the delivered formulation and delivery of the drug from the inhalation device. Our know-how in extractables and leachables studies means that we can ensure that the product container/packaging system demonstrates sufficient stability 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 guidelines for stability studies, we offer a truly flexible stability outsourcing partnership. With integrated storage and testing capability, our expertise 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. 

 
The International Conference on Harmonization (ICH) has been working closely with industry for decades on developing mutually agreeable ways of working for stability programs, to ensure the design provides the quality of data needed to support the global marketing of pharmaceutical products. A range of guidance documents covering all anticipated variables within a stability program are published, adopted and mutually recognized by all regulatory agencies. Our teams have over 20 years of experience in study design for stability testing programs in accordance with these key stability guidance documents:

ICH Q1A (R2) Stability Testing of New Drug Substances and Products
ICH Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
ICH Q1C Stability Testing of New Dosage Forms
ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Products & Substances
ICH Q1E Evaluation of Stability Data
ICH Q1F Stability Data Package for Registration Applications In Climatic Zones III and IV
ICH Q5C Stability testing of biotechnological/biological products
 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
AMER
+1 908 534 4445 x600
UK:
+44 1763 261648
Switzerland:
+41 61 686 4800