Guidelines for Stability Testing of Aseptically Processed Drugs
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drugs that are processed aseptically. Stability testing is critical to ensure that these drugs maintain their sterility, safety, and efficacy throughout their shelf life under various storage conditions.
2) Scope
This SOP applies to all drugs processed aseptically, including sterile injectables, ophthalmics, 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
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, and potency) relevant to the aseptically processed drug.
- Select appropriate analytical methods (e.g., Sterility Testing, HPLC) to evaluate these parameters.
- Define storage conditions (e.g., room temperature, refrigeration) based on the product’s characteristics and regulatory guidelines.
- Develop a detailed 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 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 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 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 <797>: Pharmaceutical Compounding – Sterile Preparations
8) SOP Version
Version 1.0