Guidelines for Stability Testing of Highly Potent Drugs
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on highly potent drugs. These drugs require special handling and storage conditions due to their high pharmacological activity and sensitivity to environmental factors.
2) Scope
This SOP applies to all highly potent drugs produced, handled, or stored by the organization, including cytotoxic drugs, hormonal agents, and immunosuppressants. It is intended for personnel involved in formulation, quality control, and regulatory affairs.
3) Responsibilities
Formulation Scientist: Responsible for designing the stability study protocol and selecting
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, content uniformity, and physical appearance) relevant to the highly potent drug.
- Select appropriate analytical methods (e.g., HPLC, spectrophotometry) to evaluate these parameters.
- Define storage conditions (e.g., controlled room temperature, refrigerated, light protection) 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
Highly Potent Drug 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
USP <800>: Hazardous Drugs – Handling in Healthcare Settings
8) SOP Version
Version 1.0