Standard Operating Procedure for Blend Uniformity Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for testing blend uniformity of granule formulations in the pharmaceutical industry to ensure consistent distribution of active ingredients.

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. Collect representative samples from different batches or lots as per the sampling plan.
   2. Ensure samples are homogenized and mixed thoroughly.
2. Testing:
   1. Weigh the appropriate amount of sample according to the testing method.
   2. Analyze the sample using a suitable analytical technique (e.g., HPLC, UV-Vis spectroscopy) to determine the content of active ingredient(s).
   3. Repeat the analysis for multiple samples from the same batch.
3. Calculation:
   1. Calculate the blend uniformity using statistical methods such as mean, standard deviation, and relative standard deviation (RSD).
   2. Evaluate the results against acceptance criteria specified in the testing protocol.
4. Acceptance Criteria:
   1. Compare the results of individual sample analyses to ensure they meet specified criteria for uniformity.
   2. Assess uniformity based on the statistical evaluation of active ingredient content across