How do you test your product's shelf life?

1 What is GMP stability testing?

GMP stability testing is a process of exposing your product to various temperatures, humidity levels, light exposure, and other stress factors that may affect its physical, chemical, microbiological, or functional properties. The purpose of stability testing is to establish a shelf life for your product, which is the period of time during which your product meets its specifications and remains safe and effective for use. Stability testing also helps you identify any potential degradation pathways, stability-indicating parameters, and storage conditions for your product.

2 How do you design a stability test?

The design of a stability test depends on several factors, such as the type and nature of your product, the intended market and regulatory requirements, the expected storage and distribution conditions, and the available resources and equipment. Generally, you should follow the guidelines and standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which provide a framework for stability testing of new drug substances and products, as well as other relevant industry or regional guidelines. You should also consult with your quality assurance and control teams, as well as external experts, to ensure that your test design is scientifically sound and compliant.

3 What methods and equipment do you need?

When performing stability testing, the methods and equipment you need vary depending on the type and nature of your product. Commonly used pieces of equipment include stability chambers, analytical instruments, and test methods. It's important to ensure that all of these items meet the specifications and validation criteria of the ICH or other applicable guidelines. Additionally, all instruments and methods should be validated and qualified according to the ICH or other applicable guidelines, and they should be calibrated and maintained regularly. This will ensure that your product samples are tested accurately and precisely, with robust results that are indicative of product stability.

4 What factors and challenges should you consider?

When conducting stability testing, there are several factors and challenges to consider. You should determine the appropriate sample size and frequency based on the statistical analysis and confidence level of your test results, as well as the availability and cost of your product. Additionally, both accelerated and real-time testing should be performed to estimate the shelf life of your product. Accelerated testing involves exposing your product to higher than normal stress conditions, while real-time testing involves exposing your product to the intended storage conditions. Appropriate models and equations should be used to extrapolate the accelerated data to the real-time data, and to establish the shelf life of your product. Furthermore, detailed protocols and reports should be prepared for your stability testing, which include objectives, scope, rationale, design, methods, equipment, samples, data analysis, results, conclusions, and recommendations. Any deviations, changes or issues that may occur during your test should also be documented along with how they are resolved or justified.

5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?