Standard Operating Procedure for Stability Studies and Monitoring in Otic Manufacturing Unit
1) Purpose
To establish procedures for conducting stability studies and monitoring of Otic (Ear) Dosage Forms to ensure product quality and shelf-life determination.
2) Scope
This SOP applies to all stability studies conducted on raw materials, intermediates, and finished Otic (Ear) Dosage Forms products within the manufacturing unit.
3) Responsibilities
Quality Control (QC) Department: Responsible for designing, conducting, and analyzing stability studies.
Quality Assurance (QA) Department: Responsible for oversight and review of stability study protocols and results.
Production Department: Responsible for providing samples and facilitating stability testing as per schedule.
4) Procedure
4.1 Stability Study Design
4.1.1 Protocol Development
4.1.1.1 QC develops stability study protocols based on regulatory requirements and product characteristics.
4.1.1.2 Define study parameters including storage conditions, testing frequency, and duration.
4.1.2 Sample Collection
4.1.2.1 Collect representative samples of each batch for stability testing.
4.1.2.2 Ensure samples are properly labeled and stored under controlled conditions.
4.2 Stability Testing
4.2.1 Testing Schedule
4.2.1.1 Perform stability testing at predefined time points (e.g., 0, 3, 6, 12 months).
4.2.1.2 Use validated analytical methods to assess physical, chemical, and microbiological attributes.
4.2.2 Storage Conditions
4.2.2.1 Monitor and maintain stability chambers or conditions as per defined protocols.
4.2.2.2 Record environmental conditions (e.g., temperature, humidity) during storage.
4.3 Stability Data Analysis
4.3.1 Data Review
4.3.1.1 QC reviews stability testing data for compliance with acceptance criteria.
4.3.1.2 Evaluate trends and deviations from initial specifications.
4.3.2 Trend Analysis
4.3.2.1 Analyze stability data to determine shelf-life and storage recommendations.
4.3.2.2 Prepare stability summary reports for review and approval by QA.
4.4 Stability Report and Recommendations
4.4.1 Report Preparation
4.4.1.1 Compile stability study results and observations into a final report.
4.4.1.2 Include recommendations for product storage conditions and shelf-life determination.
4.4.2 QA Review and Approval
4.4.2.1 QA reviews stability reports for completeness and accuracy.
4.4.2.2 Approve stability study outcomes and recommendations.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Stability study protocols
Stability testing records
Final stability report template
7) Reference, if any
GMP guidelines for stability studies in pharmaceutical manufacturing
8) SOP Version
Version 1.0
