Guidelines for Stability Testing of Drugs with Special Storage Requirements
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drugs with special storage requirements. Stability testing ensures that these drugs maintain their safety, efficacy, and quality under specific storage conditions throughout their shelf life.
2) Scope
This SOP applies to all drugs with special storage requirements, including those requiring protection from light, moisture, and specific temperatures, 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 selecting appropriate stability-indicating parameters.
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, degradation, moisture content) relevant to the drug with special storage requirements.
- Select appropriate analytical methods (e.g., HPLC, UV Spectroscopy, Karl Fischer Titration) to evaluate these parameters.
- Define special storage conditions (e.g., protection from light, specific humidity levels, controlled temperature) based on the product’s characteristics and regulatory guidelines.
- Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.
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 special storage conditions.
4.3 Testing Schedule:
- 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 under special storage conditions.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
4.4 Data Analysis and Reporting:
- Analyze data using statistical methods to determine trends and compliance with acceptance criteria.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling under special 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
Special Storage Requirement 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
8) SOP Version
Version 1.0