Standard Operating Procedure for Particle Size Distribution in Gels
1) Purpose
The purpose of this SOP is to establish procedures for measuring and evaluating the particle size distribution of gels to ensure consistency and quality control during manufacturing.
2) Scope
This SOP applies to all personnel involved in particle size distribution testing within the pharmaceutical manufacturing facility’s gels production department.
3) Responsibilities
Quality Control (QC) Analysts: Perform particle size distribution testing according to this SOP.
Production Supervisors: Provide samples for testing and ensure compliance with testing schedules.
Quality Assurance (QA) Team: Review and approve test results to ensure compliance with specifications.
Engineering Department: Maintain equipment used for particle size distribution testing.
4) Procedure
4.1 Sample Preparation
4.1.1 Collect representative samples of the gel product as per sampling procedures.
4.1.2 Prepare samples according to specified dilution or dispersion methods.
4.2 Particle Size Measurement
4.2.1 Use appropriate particle sizing techniques such as laser diffraction or microscopy.
4.2.2 Calibrate equipment prior to use and verify method suitability for gel samples.
4.3 Data Collection and Analysis
4.3.1 Record particle size distribution data obtained from the analysis.
4.3.2 Analyze data to determine mean particle size, size distribution range, and any deviations from specifications.
4.4 Reporting
4.4.1 Prepare particle size distribution reports summarizing test results and statistical analysis.
4.4.2 Review and approve reports by QA for accuracy and compliance with acceptance criteria.
4.5 Equipment Maintenance
4.5.1 Clean and maintain particle size distribution equipment according to manufacturer instructions and SOPs.
4.5.2 Perform calibration and verification of equipment at scheduled intervals or after maintenance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Particle Size Distribution Testing Protocol
– Particle Size Distribution Reports
– Equipment Calibration and Maintenance Records
7) Reference, if any
– USP <1231>: Water for Pharmaceutical Purposes
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific particle size distribution procedures and guidelines
8) SOP Version
Version 1.0