Standard Operating Procedure for Stability Testing of Granules

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability testing of granules in the pharmaceutical manufacturing process to assess their shelf-life under various storage conditions.

2) Scope

This SOP applies to all personnel involved in stability testing of granules within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control Analysts: Responsible for conducting stability testing as per the SOP.
Quality Assurance: Responsible for reviewing stability testing protocols and results.
Research and Development: Responsible for providing stability study design inputs.

4) Procedure

1. Protocol Development:
   1. Develop a stability testing protocol outlining the study design, storage conditions, and testing intervals.
   2. Ensure the protocol complies with regulatory requirements.
2. Sample Preparation:
   1. Prepare representative samples of the granules for stability testing.
   2. Document sample details including batch number, manufacturing date, and storage conditions.
3. Storage Conditions:
   1. Store the samples under controlled conditions (e.g., temperature, humidity) as per the protocol.
   2. Monitor storage conditions continuously and record deviations if any.
4. Testing Intervals:
   1. Retrieve samples at predefined intervals for testing.
   2. Perform appropriate tests (e.g., physical, chemical, microbial) as per the stability protocol.
5. Data Analysis:
   1. Analyze stability data to assess any changes in the granules over time.
   2. Compare results against acceptance criteria specified in the protocol.
6. Reporting:
   1. Prepare stability study reports summarizing findings and conclusions.
   2. Include recommendations for shelf-life and storage conditions based on stability data.
7. Review and Approval:
   1. Quality assurance reviews the stability study report.
   2. Approve the stability study outcomes and recommendations.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Stability Testing Protocol, Stability Study Report

7) Reference, if any

ICH guidelines (e.g., ICH Q1A(R2), ICH Q2(R1)) and other relevant regulatory guidelines.

8) SOP Version

Version 1.0