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).