Guidelines for Stability Testing of Chiral Drugs
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on chiral drugs. Stability testing ensures that chiral drugs maintain their stereochemistry, safety, efficacy, and quality throughout their shelf life under various storage conditions.
2) Scope
This SOP applies to all chiral drugs, including enantiomerically pure drugs and racemic mixtures, 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
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., enantiomeric purity, degradation products, potency) relevant to the chiral drug.
- Select appropriate analytical methods (e.g., Chiral HPLC, Circular Dichroism Spectroscopy) to evaluate these parameters.
- Define storage conditions (e.g., room temperature, refrigerated) 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 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 in stability 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
Chiral Drug Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q3A(R2): Impurities in New Drug Substances
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
8) SOP Version
Version 1.0