Guidelines for Stability Testing of Drugs in Aseptic Processing
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drugs produced through aseptic processing. Stability testing ensures that these drugs maintain their sterility, safety, efficacy, and quality under various storage conditions throughout their shelf life.
2) Scope
This SOP applies to all drugs produced by aseptic processing, including injectables, ophthalmic solutions, and biologics, 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., sterility, particulate matter, pH, potency) relevant to the drug produced via aseptic processing.
- Select appropriate analytical methods (e.g., Sterility Testing, HPLC, Particle Size Analysis) 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 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
6) Documents, if any
Aseptic Processing Drug Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
8) SOP Version
Version 1.0