Guidelines for Stability Testing of Oncology Drugs
1) Purpose
The purpose of this SOP is to provide guidelines for conducting stability studies on oncology drugs. These drugs, used in cancer treatment, often have complex formulations and require stability testing to ensure their efficacy, safety, and quality under various storage conditions throughout their shelf life.
2) Scope
This SOP applies to all oncology drugs produced, handled, or stored by the organization, including oral, injectable, and other dosage forms. It is intended for personnel involved in formulation development, quality control, and regulatory affairs.
3) Responsibilities
Formulation Scientist: Responsible for designing the
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, dissolution rate, and content uniformity) relevant to the oncology drug formulation.
- Select appropriate analytical methods (e.g., HPLC, LC-MS) to evaluate these parameters.
- Define storage conditions (e.g., room temperature, refrigeration) based on product 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 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 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
LC-MS: Liquid Chromatography-Mass Spectrometry
6) Documents, if any
Oncology 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
FDA Oncology Drug Regulations: 21 CFR Part 312
8) SOP Version
Version 1.0