Guidelines for Stability Testing of Drugs in Novel Packaging
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drugs in novel packaging. Stability testing ensures that drugs maintain their safety, efficacy, and quality when packaged in new or innovative materials and designs throughout their shelf life.
2) Scope
This SOP applies to all drug products packaged in novel materials, such as bio-based plastics, smart packaging, or modified-atmosphere packaging, produced or handled by the organization. It is intended for personnel involved in packaging development, quality control, and regulatory
3) Responsibilities
Packaging 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,
4) Procedure
4.1 Study Design:
- Identify stability-indicating parameters (e.g., moisture ingress, UV light exposure, oxygen permeability) relevant to the novel packaging material.
- Select appropriate analytical methods (e.g., Moisture Vapor Transmission Rate, UV Spectroscopy, Oxygen Permeability Testing) to evaluate these parameters.
- Define storage conditions (e.g., room temperature, accelerated aging) 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 package them in the novel materials being evaluated.
- Label samples with batch numbers, packaging type, 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 under novel packaging 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 in novel packaging.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Novel Packaging 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