Standard Operating Procedure for Blend Uniformity Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting blend uniformity testing on granule formulations in the pharmaceutical industry to ensure homogeneity and consistency.

2) Scope

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

3) Responsibilities

Analytical Chemist: Responsible for performing blend uniformity testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the blend uniformity testing procedure and results.

4) Procedure

1. Sample Collection:
   1. Select samples according to the sampling plan from different locations in the blend.
   2. Ensure samples are representative of the entire batch.
2. Sample Preparation:
   1. Prepare samples for analysis by homogenizing and sieving if necessary.
3. Testing:
   1. Perform analysis using a suitable method (e.g., HPLC, UV-Vis spectroscopy) to quantify the active ingredient.
   2. Record measurements for each sample.
4. Calculation:
   1. Calculate the mean, standard deviation, and coefficient of variation (CV) for the active ingredient content across samples.
5. Acceptance Criteria:
   1. Compare results against predetermined acceptance criteria based on regulatory guidelines and internal specifications.
   2. Evaluate blend uniformity based on statistical analysis of results.
6. Reporting:
   1. Document all results, calculations, and observations in the appropriate logbook or electronic system.
   2. Include any deviations or corrective actions taken during testing.
7. Documentation:
   1. Maintain accurate records of blend uniformity testing, including raw data, calculations, and reports.
   2. File documentation in accordance with Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
HPLC: High Performance Liquid Chromatography
UV-Vis: Ultraviolet-Visible Spectroscopy
GDP: Good Documentation Practices

6) Documents, if any

Blend Uniformity Testing Protocol, Test Results, Blend Uniformity Report

7) Reference, if any

Pharmacopeial guidelines for blend uniformity testing of pharmaceutical granules.

8) SOP Version

Version 1.0