Standard Operating Procedure for Homogeneity Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting homogeneity testing on granule formulations in the pharmaceutical industry to ensure uniform distribution of the active pharmaceutical ingredient (API) and excipients.

2) Scope

This SOP applies to all personnel involved in the homogeneity testing of granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Quality Control (QC) Analyst: Responsible for performing homogeneity testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the homogeneity testing procedure and results.

4) Procedure

1. Sample Preparation:
   1. Ensure that the sample is representative of the batch by mixing thoroughly.
   2. Divide the sample into smaller aliquots for testing.
2. Testing Method:
   1. Use appropriate analytical techniques such as content uniformity testing or sampling at multiple locations.
   2. Perform testing according to established protocols and specifications.
3. Data Collection:
   1. Record the test results, including the concentration or content of the API or other specified parameters.
   2. Document any deviations or observations during testing.
4. Analysis and Acceptance Criteria:
   1. Analyze the test results against predefined acceptance criteria.
   2. Evaluate the uniformity of the sample and determine if it meets the specified requirements.
5. Reporting:
   1. Prepare a homogeneity testing report summarizing the procedure, results, and conclusions.
   2. Submit the report to the QA department for review and approval.
6. Documentation:
   1. Maintain records of all homogeneity testing activities, including raw data, calculations, and reports.
   2. File the documentation in accordance with Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
GDP: Good Documentation Practices

6) Documents, if any

Homogeneity Testing Protocol, Test Results, Homogeneity Testing Report

7) Reference, if any

Pharmacopeial guidelines for content uniformity testing.

8) SOP Version

Version 1.0