Standard Operating Procedure for Granule Size Distribution
Purpose
The purpose of this SOP is to define the procedures for determining granule size distribution during the tablet/ capsule manufacturing process to ensure product quality and consistency.
Scope
This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for assessing granule size distribution.
Responsibilities
- Quality Control Analysts: Responsible for conducting granule size distribution analysis according to this SOP.
- Production Department: Providing granule samples for testing and cooperating with quality control personnel.
- Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.
Procedure
- Collect representative samples of granules from the manufacturing process.
- Prepare the samples for analysis by following established procedures for sample preparation.
- Use appropriate analytical techniques such as sieve analysis or laser diffraction to determine granule size distribution.
- Record and analyze the results obtained from the granule size distribution analysis.
- Compare the results against predefined acceptance criteria.
- Document all testing procedures, observations, and results accurately and comprehensively.
- Review and approve the test results by authorized personnel.
- Initiate corrective actions if deviations from acceptance criteria are identified.
Abbreviations Used
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
Documents
- Granule Size Distribution Testing Protocol
- Standard Operating Procedures Manual
- Batch Records
- Quality Control Reports
- Deviation Reports
Reference
No specific references are cited for this SOP.
SOP Version
Version 1.0
