What are stability zones and stability conditions?
Know different climatic zones by ICH in the world for stability conditions including Temperate, Mediterranean / subtropical, Hot dry, Hot humid / tropical and hot & higher humidity zones. According to the ICH guidelines for stability studies, the climate of the world is divided into five different zones.
What is stability study protocol?
The stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests.
What is quality stability?
Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity.
What is on going stability?
An ongoing stability programme is established to monitor the product over its shelf-life and to determine that the product remains and can be expected to remain within specifications under the storage conditions on the label.
What are the different types of stability testing?
Two common types of stability tests are real-time and accelerated. Real-time tests are accomplished by storing pharmaceutical products according to the recommended conditions and checking or monitoring the product until it fails.
How many stability zones are there?
Throughout the world, there are 5 different ICH Stability Zones:
| Climatic Zone | Type of Climate | Long term Stability Testing Recommended Conditions |
|---|---|---|
| Zone II | Mediterranean/Subtropical | 25°C/60%RH |
| Zone III | Hot, Dry | 30°C/35%RH |
| Zone IVa | Hot Humid/ Tropical | 30°C/65%RH |
| Zone IVb | Hot/ Higher Humidity | 30°C/75%RH |
What is pharmaceutical stability?
Stability of a pharmaceutical product means how long it can maintain its original form without any visible changes under the influence of various environmental factors like temperature, humidity, light.
How do you perform a stability study?
Determine that there are sufficient sample materials to conduct the stability study. The total sample quantity must be validated to determine if there is sufficient quantity of material for each variant time point sample. This validation ensures there is sufficient material to complete the required analysis.
How do you test stability?
7 Steps for Stability Testing
- Step 1: Batch Production.
- Step 2: Product Container Filling.
- Step 3: Initial Test (Time Point Zero).
- Step 4: Product Storage.
- Step 5: Product Evaluation.
- Step 6: Determine Stability.
- Step 7: Conclusion Report.
How many types of stability are there?
There are three types of equilibrium: stable, unstable, and neutral.
What is ICH stability?
The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted.
What is stability chamber?
Stability Chambers are specially designed equipment for the testing of products and also to determine their shelf life such as drug, electrical components, industrial materials etc which enables you to tweak parameters like temperature, humidity to conduct a thorough check over varied conditions.
Who is responsible for the ongoing stability testing of medicines?
Responsibility for the ongoing stability program Stability testing for listed and complementary medicines is mandatory. All responsibilities related to ongoing stability testing should be defined in a GMP agreement (unless the sponsor, manufacturer and authorised person conducting release for supply are all from the same entity).
How many products should be placed on the ongoing Stability Program?
At least one batch of product from each group each year should be placed on the ongoing stability program under the predetermined study protocol. A grouping approach can be undertaken with stability studies of listed and complementary medicines, because of the lower risk generally associated with these medicines.
What is ongoing stability testing in packaging?
Ongoing stability testing is of the finished packed product. Consider whether. bulk product or intermediate product should also be part of the ongoing stability program, particularly where bulk product is stored prior to being packaged or transported from a manufacturing site to a packaging site.
Does the guidance apply to listed and export-only medicines?
This guidance is only applicable to manufacturers and sponsors of listed medicines and complementary medicines (including registered complementary medicines). This guidance does not apply to a medicine listed for export-only when the medicine would not be a listed or complementary medicine if supplied in Australia.