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