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 data acquisition.
4.3.3 Ensure testing conditions (e.g., humidity, temperature) are controlled and documented.
4.4 Data Analysis:
4.4.1 Analyze data obtained from testing to assess the uniformity of powder particle size distribution or other specified parameters.
4.4.2 Calculate statistical measures such as mean particle size, standard deviation, or coefficient of variation as applicable.
4.4.3 Compare results against acceptance criteria defined in pharmacopeial standards or internal specifications.
4.5 Reporting:
4.5.1 Prepare a Bulk Powder Uniformity Testing Report summarizing the sampling details, testing methods, results, and conclusions.
4.5.2 Include all relevant data, calculations, and statistical analyses in the report.
4.5.3 Review and approve the report by QC Manager before release.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Bulk Powder Uniformity Testing Report
Method Validation Protocol and Report
Instrument Calibration Records
7) Reference, if any
USP General Chapter <905> – Uniformity of Dosage Units
Pharmacopeial standards for bulk powder uniformity testing in pharmaceutical substances
8) SOP Version
Version 1.0
