Stability Studies: GMP and non-GMP
ICH Stability Studies are a critical part of the drug development process. The results of these studies are used to determine the retest interval for an Active Pharmaceutical Ingredient (API) and dictate the shelf life for a drug product. Stability studies are typically initiated with material produced from either the first demonstration batch or from the batch used to support toxicology studies. The stabilities studies are then continued with each GMP batch.. For cost-efficiency, an abbreviated study can also be performed when multiple batches are made from the same process.
Stability Chambers Set to ICH Conditions
J-Star has multiple stability chambers set to ICH conditions for long-term and accelerated stability studies. Although typically conducted during forced degradation, photostability studies may also be considered as part of the stability study protocol.
Color-Coding for Accuracy
Color coding is used for both chamber and sample labeling, allowing chemists to easily recognize the relevant condition and reduce the potential for human error.
| Temperature | Relative Humidity | Color Code |
|---|---|---|
| -20 °C ± 5 °C | not controlled | Purple |
| -20 °C ± 5 °C | not controlled | Blue |
| 25 °C ± 2 °C | 60% RH ± 5% RH | Green |
| 30 °C ± 2 °C | 65% RH ± 5% RH | Green |
| 40 °C ± 2 °C | 75% RH ± 5% RH | Red |
ICH Guideline Test Intervals
Test intervals typically follow ICH guidelines and may be modified as deemed appropriate for clinical APIs or as requested by the study sponsor. Backup samples are normally included for possible future investigation or if the study is extended.
Stability Study Quality Attributes
The quality attributes included in J-Star Research stability studies are those specifications (or other characteristics) of the API susceptible to change on storage. Our testing also includes a visual assessment of any interactions of the API with the container or closure mechanism.
A phase-appropriate study and protocol is provided by J-STAR and subject to review by the client.
Stability Study Analysis & Reporting
In the event that results show little or no change (i.e. a clear trend with time), the retest interval or shelf-life is reported based in accordance with ICH guidelines.
If any test shows variability or an apparent trend with time, analysis may be used to establish a proposed retest interval that is consistent with the Q1E guidance.
Finally, stability study summary reports are provided to the client with the recommended storage conditions and relevant statistical analyses.