Standard Operating Procedure for Blend Uniformity Testing
Purpose
The purpose of this SOP is to outline the procedures for conducting blend uniformity testing during the tablet/ capsule manufacturing process to ensure homogeneity and consistency of the blend.
Scope
This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for conducting blend uniformity testing.
Responsibilities
- Quality Control Analysts: Responsible for conducting blend uniformity testing according to this SOP.
- Production Department: Providing samples for testing and cooperating with quality control personnel.
- Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.
Procedure
- Collect a representative sample of the blend according to defined sampling procedures.
- Weigh and subdivide the sample as per the specified testing protocol.
- Prepare samples for analysis using appropriate techniques and equipment.
- Perform blend uniformity testing using validated methods and instruments.
- Analyze the results and compare them against established acceptance criteria.
- Document all testing procedures, observations, and results accurately and legibly.
- Review and approve the test results by authorized personnel.
- Initiate appropriate corrective actions in case of deviations from acceptance criteria.
Abbreviations Used
SOP: Standard Operating Procedure
QC: Quality Control
Documents
The following documents are relevant to this SOP:
- Blend Uniformity 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
