- SOP for Operation, Calibration and Monitoring of Stability Walk In Chamber (30±2°C/75±5 RH)
- FAT for Stability Chamber
- Installation Qualification for Stability Chamber
- Operational Qualification for Stability Chamber
- Performance Qualification for Stability Chamber
A Practical Overview
Stability studies in pharma are designed to show how the quality of a drug substance or product changes over time under the influence of temperature, humidity and light. The data are used to set shelf-life, re-test period and storage conditions on the label, as required by ICH and WHO guidelines. European Medicines Agency (EMA)+1
The core global standard is ICH Q1A (R2), which defines the stability data package needed for registration of new drug substances and products. It specifies long-term, intermediate and accelerated storage conditions (for example 25 °C/60% RH or 30 °C/65% RH for long-term; 40 °C/75% RH for accelerated) and minimum testing duration. European Medicines Agency (EMA)+1 A newer consolidated draft, ICH Q1 “Stability Studies for Drug Substances and Drug Products”, extends these principles across product lifecycles.
In practice, stability programmes usually include:
- Long-term studies at recommended storage conditions to support the full proposed shelf-life.
- Accelerated studies at higher temperature and humidity to reveal potential degradation pathways and support extrapolation.
- Intermediate studies, when accelerated conditions cause significant change and additional information is needed.
Typical test parameters are appearance, assay, degradation products, dissolution (for solid orals), pH, preservatives, container-closure integrity and, where relevant, microbiological quality.
For each product, companies define a stability protocol: batches to be placed on study, storage conditions, test intervals and analytical methods. Results are statistically evaluated to confirm that all attributes remain within specification through the proposed expiry period; if justified, limited extrapolation beyond the tested period may be accepted by regulators.
Stability studies continue after approval as ongoing (commitment) stability to monitor product performance and support post-approval changes. Robust stability programme demonstrate that medicines will remain safe, effective and of consistent quality from manufacture until the labelled expiry date—across all climatic zones where they are distributed.