Procedure for Blend Uniformity Analysis

1) Purpose

The purpose of this SOP is to outline the procedure for performing blend uniformity testing to ensure the homogeneity of pharmaceutical blends prior to tablet or capsule production.

2) Scope

This SOP applies to all pharmaceutical blends prepared for tablet or capsule production within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting blend uniformity testing and ensuring compliance with this SOP.
Production Department: Responsible for providing samples of the blend for testing and adhering to blend uniformity standards.

4) Procedure

4.1 Sampling:
    4.1.1 Collect blend samples at various points within the blender according to the sampling plan.
    4.1.2 Ensure samples are representative of the entire blend.
4.2 Sample Preparation:
    4.2.1 Weigh a specific amount of each sample as per the analytical method.
    4.2.2 Dissolve or extract the sample in a suitable solvent if required.
4.3 Analysis:
    4.3.1 Perform the appropriate analytical method (e.g., HPLC, UV spectrophotometry) to determine the active ingredient concentration in each sample.
    4.3.2 Record the results for each sample.
4.4 Calculation:
    4.4.1 Calculate the mean concentration of the active ingredient from all samples.
    4.4.2 Determine the relative standard deviation (RSD) to assess uniformity.
4.5 Acceptance Criteria:
    4.5.1 The blend is considered uniform if the RSD is within the specified limits (< 5% RSD typically).

5) Abbreviations, if any

HPLC: High-Performance Liquid Chromatography
RSD: Relative Standard Deviation
UV: Ultraviolet

6) Documents, if any

Blend Uniformity Test Record
Analytical Method SOP
Sampling Plan Document

7) Reference, if any

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0