Procedure for Bulk Powder Uniformity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting bulk powder uniformity testing in pharmaceutical substances using appropriate analytical techniques.

2) Scope

This SOP applies to all pharmaceutical powders within the facility that require bulk powder uniformity testing as part of quality control, following pharmacopeial guidelines and internal specifications.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing bulk powder uniformity testing and ensuring compliance with this SOP.
Analytical Laboratory: Responsible for conducting analysis using suitable techniques and interpreting results accurately.

4) Procedure

4.1 Sample Preparation:
    4.1.1 Obtain representative samples of pharmaceutical powders requiring uniformity testing.
    4.1.2 Label samples with batch numbers, dates, and any other relevant information.
    4.1.3 Ensure samples are properly mixed and homogenized to achieve uniform distribution of components.

4.2 Sampling:
    4.2.1 Select a sufficient number of sampling units from the sample batch, ensuring they are randomly chosen.
    4.2.2 Use appropriate sampling tools and techniques to minimize variability between individual samples.
    4.2.3 Document the sampling plan and rationale for sample selection.

4.3 Testing Method:
    4.3.1 Perform testing using an appropriate method such as sieve analysis, laser diffraction, or other validated techniques.
    4.3.2 Follow method-specific procedures for sample preparation, instrument calibration, and