Guidelines for Stability Testing of Controlled-Temperature Products
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on products that require controlled-temperature conditions. Stability testing is essential to ensure that these products maintain their safety, efficacy, and quality throughout their shelf life.
2) Scope
This SOP applies to all products that require controlled-temperature storage, including vaccines, biologicals, and temperature-sensitive formulations, produced or handled by the organization. It is intended for personnel involved in formulation development, quality control, and regulatory compliance.
3) Responsibilities
Formulation Scientist: Responsible for designing the stability study protocol and
Quality Control (QC) Team: Responsible for conducting stability tests according to the approved protocol and documenting results.
QA Team: Responsible for reviewing data, ensuring regulatory compliance, and approving the final stability report.
4) Procedure
4.1 Study Design:
- Identify stability-indicating parameters (e.g., potency, purity, and degradation) relevant to the controlled-temperature product.
- Select appropriate analytical methods (e.g., HPLC, UV spectroscopy) to evaluate these parameters.
- Define storage conditions (e.g., 2-8°C, -20°C) based on the product’s characteristics and regulatory guidelines.
- Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.
- Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers with controlled-temperature settings as specified in the study protocol.
- Conduct initial testing on all samples to establish baseline data for the selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes over time.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
- Analyze data using appropriate statistical methods to determine trends and compliance with acceptance criteria.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
- Submit the report for QA review and archiving.
4.2 Sample Preparation:
4.3 Testing Schedule:
4.4 Data Analysis and Reporting:
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Controlled-Temperature Product Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
WHO Guidelines: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
8) SOP Version
Version 1.0