Storage Conditions and Sampling Frequency Q1A(R2)
| Storage Condition | Temperature | Relative Humidity (RH) | Sampling frequency |
|---|---|---|---|
| Long-term | 25°C | 60% | T0, T3, T6, T9, T12, T18, T24, T36 months |
| Intermediate Conditions | 30°C | 65% | T0, T3, T6, T9, T12 months |
| Accelerated Conditions | 40°C | 75% | T0, T3, T6 months |
Stability studies are imperative to ensure the quality, safety, and efficacy of pharmaceutical products throughout their shelf life. These studies help determine the appropriate storage conditions and shelf-life of products.
In the pharmaceutical industry, drug stability studies detect potential degradation and define optimal storage conditions. They directly influence the expiration date and storage recommendations, ensuring pharmaceutical products remain safe and effective until the end of their shelf life.
Presentation of ICH
ICH, which stands for International Council for Harmonisation, was founded in 1990 by regulatory authorities and pharmaceutical industry associations from Europe, Japan, and the United States. Its aim is to harmonize technical requirements for pharmaceutical products to ensure their safety, quality, and efficacy. The guidelines set by ICH standards are widely adopted by regulatory authorities and pharmaceutical industries worldwide.
Fundamental principles of ICH stability studies
ICH recommends several types of stability tests:
- Accelerated stability tests: Simulate extreme storage conditions to predict the product's shelf life in a reduced time frame.
- Long-term stability tests: Assess the stability of products under normal storage conditions over an extended period.
- Photostability tests: Determine the product's sensitivity to light.
Durations and Conditions of Stability Studies
The durations of stability studies vary depending on the type of test and the product under study:
- Accelerated studies: Typically conducted over 6 months.
- Long-term studies: Can extend from 12 to 60 months. Long-term conditions help define the product's expiration date.
They are conducted in climatic chambers, under controlled humidity and according to conditions defined by the ICH standard. Unfavorable results may lead to formulation changes or adjustments to storage conditions. Standard storage conditions include specific temperatures and humidities, such as 25°C/60% RH and 30°C/65% RH.
Definition of Specific Requirements According to Product Type
For conventional pharmaceutical products, guidelines such as ICH Q1A(R2), Q1B, and Q1C define stability requirements. For biotechnological and biological products, ICH Q5C guidelines provide specific recommendations considering their sensitivity and complexity.
FAQ
There is a specific standard for the stability study of medical devices intended for in vitro diagnostic reagents (ISO 23640), but it does not provide any information on the parameters to be applied. However, an American standard, ASTM F1980, can serve as a guide for medical device manufacturers.
Références
- ICH Guidelines Q1A(R2): Stability Testing of New Drug Substances and Products
- ICH Guidelines Q1B: Photostability Testing of New Drug Substances and Products
- ICH Guidelines Q1C: Stability Testing for New Dosage Forms
- ICH Guidelines Q5C: Stability Testing of Biotechnological/Biological Products