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Stability Testing

GBI also offers stability studies of cGMP material. Stability testing determines if the quality of a drug substance or drug product is altered over time by various environmental factors such as light, temperature, and humidity.

A drug “substance,” often referred to as an Active Pharmaceutical Ingredient (API), is the un-formulated material that may subsequently be formulated with excipients to produce a dosage form. A drug “product” is the formulated mixture of the drug substance and excipients comprising the final marketed dosage form.

For a drug substance, stability testing determines the “re-test period,” the time frame during which the drug substance is expected to remain within its specification and therefore can be used in the manufacture of a given drug product. After the established re-test period has elapsed, a drug substance can only be used if additional specification testing is performed, the material passes inspection, and the substance is distributed soon after meeting acceptance criteria.

GBI’s ICH Stability Testing Parameters

The primary stability testing guidance document for drug substances and products marketed in Japan, Europe, and the United States is the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products – Q1A(R2).

The recommended storage conditions are, depending on the storage capabilities, long-term (real-time) storage of the product at either:

  • 2 to 8 °C or -20 ± 5°C
  • Or ≤ -65 °C

Accelerated conditions require either:

  • 25°C ± 2°C/60% Relative Humidity (RH) ± 5% RH
  • Or 40°C ± 2°C/75% RH ± 5% RH

For long-term studies, the product should be tested at frequencies sufficient to establish the stability profile of the product. For products with a proposed shelf life of at least 36 months, the frequency of testing at the long-term storage condition should usually be once every three months over the first year and annually after that through the proposed shelf life.

As part of our CDMO biologics services, GBI generates product specific stability protocols and reports on all of this information.

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