- Understanding Stability Studies
Stability testing is used to provide evidence on how the quality of a drug substance or drug-containing cannabis varies with time under the impact of a variety of environmental factors such as temperature, humidity, and light as per applicable regulations. The stability studies are used as a tool of quality assessment to assess the impact of changes on the quality of the product during the established expiry date or re-test date. From this recommended storage conditions can be established, as well as the cadence retest periods and shelf-life. In addition, the stability study is to support the selection of container closure systems and packaging materials. The stability data is to support the submission of drug products as well.
The stability study is required in the drug development process and defined as a Critical Quality Attribute. Changes in API and formulation, manufacturing processes, packaging, analytical changes and process deviations have an impact on the stability profile. Any change should be accessed to determine if there is a need for a new stability study.
- Stability Program Process flow
The stability process flow includes requesting a stability study, planning a stability study, designing a stability study, approving a stability study protocol, launching a stability study, stability study testing, evaluation of data and documentation, completion/termination of the stability study. Each company should have and maintain a stability program that provides evidence on how the quality of a drug substance or drug varies with time under the impact of a variety of environmental factors and to establish recommended storage conditions, retest periods and shelf-life. The company should have procedures delineating the stability program requirements through whole life cycle of a drug substance and a drug product.
- Stability Indicating methods with Forced degradation studies
As per regulatory requirements (e.g. Health Canada, FDA), the validated stability indicating method must be used for the stability testing and other products testing. The stability test methods must be reliable, meaningful and specific which indicate that the change of content of active ingredients, impurities, degradation and other components in a product can be accurately determined without any interference. Method validation is required for any procedure used in the testing of in-process, release, acceptance and stability testing. The procedures for method validation including SOPs, protocols, reports should be established.
Our expertise and service
Canndelta recognizes the challenge of stability study and method validation for licensed producers, pharmaceutical companies and testing labs. That’s why we have dedicated resources to help you. With a former Senior Compliance and Enforcement Inspector from Health Canada’s Cannabis Program and with our extensive experience in stability studies, quality, compliance, and regulatory affairs, the Canndelta team can offer stability study and compliance strategies and advise on best practices. We develop stability programs and support clients to conduct all types of the stability studies at any stage of the product development in compliance with Health Canada, US-FDA, EMA and ICH regulatory requirements. In addition, we can help on stability indicating method validation. Following support services for stability studies and consultancy we can offer (including but not limit following):
- Provide strategies to establish stability program
- Write stability program master plan and SOPs
- Stability program life cycle management
- Design stability protocols of different types of stability studies, for example:
- Long term stability studies
- Intermediate stability studies
- Accelerated stability studies
- Hold time studies
- Bulk stability studies
- Stress stability studies (e.g. to support transport conditions)
- Forced degradation studies
- Photo-stability study
- Formulation evaluation stability studies
- Stability testing for R&D stages of IND, NDA and ANDA
- Commercial/post market stability studies
- Customized condition stability studies
- Perform stability data evaluation and analyses
- OOS/OOT investigation
- Stability data trending and data summary sheets/report
- Generate stability reports (summary reports for every testing interval and final reports)
- Write method validation protocols
- Method validation data analyses and evaluation
- Create method validation reports
- Quality audit
Should you have any question on stability program and method validation, feel free to contact Canndelta at 1-877-274-6777 or email@example.com.