Guidelines for Stability Testing of High-Risk Drug Products
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on high-risk drug products. These studies are essential to ensure that high-risk products maintain their safety, efficacy, and quality throughout their shelf life under various storage conditions.
2) Scope
This SOP applies to all high-risk products, including cytotoxic drugs, biologics, and controlled substances, 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
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, sterility, and degradation) relevant to the high-risk product.
- Select appropriate analytical methods (e.g., HPLC, Mass Spectrometry) to evaluate these parameters.
- Define storage conditions (e.g., controlled room temperature, refrigerated) based on the product’s characteristics and regulatory guidelines.
- Develop a detailed study protocol outlining the objectives, sampling schedule, and analytical methods.
4.2 Sample Preparation:
- Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Conduct initial testing to establish baseline data for all 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.
4.4 Data Analysis and Reporting:
- 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.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
6) Documents, if any
High-Risk 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
FDA Guidance: Stability Testing of Drug Substances and Drug Products
8) SOP Version
Version 1.0