Stability Testing Requirements for Pharmaceuticals

by | May 7, 2021 | Healthcare, Pharmaceuticals, Quality, Testing

Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence data on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors. It also establishes a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.1

The requirements for stability testing for the FDA are harmonized with the EU and Japan, so stability information generated in any one of the three regions -EU, Japan, or the US would be mutually acceptable to the other two regions.

The five factors that have an impact on the stability test data for a drug product are as follows:

  • Stress Testing: This type of test helps identify the degradation of the product and considers the effect of temperatures, humidity, oxidation, and photolysis.
  • Selection of batches: At least three primary batches of the drug substance should be utilized to perform formal stability testing. The production process must be the same as the final process to be used for production batches.
  • Container Closure Systems: Tests must be conducted on the drug that is packaged in a container closure system that is the same as the proposed final packaging.
  • Testing Frequency: Plan the testing frequency of the product in a way such that it is sufficient to establish the stability profile of the drug substance.
  • Storage Conditions: The testing must evaluate storage conditions that test its thermal stability and its sensitivity to moisture. The conditions must also cover the storage, shipment, and subsequent use.

Incorporating these five elements within the stability test plan for your drug will provide appropriate assurance of its shelf life under the various environmental factors throughout the product’s life.

Whatever challenges are in your development process, be rest assured that EMMA International is here to assist you with all your compliance needs, call us today at 248-987-4497 or email us at info@emmainternational.com to know more.


1FDA (2003) Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products retrieved on 05/06/2021 from https://www.fda.gov/media/71707/download

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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