A well-written Standard Operating Procedure (SOP) for disintegration testing is essential for ensuring consistent, compliant results in pharmaceutical quality control.
Key SOP Components
Purpose and Scope
Clearly define what the SOP covers, including applicable dosage forms and test methods.
Equipment Requirements
- Disintegration apparatus meeting USP/IP specifications
- Calibrated thermometers
- Timer with accuracy to seconds
- Appropriate beakers for medium preparation
Medium Preparation
Specify:
- Composition of disintegration medium
- Preparation instructions
- Temperature requirements (37°C ± 2°C)
- Volume requirements
Test Procedure
Step-by-step instructions including:
- Equipment setup and verification
- Medium preparation and temperature equilibration
- Sample placement in basket tubes
- Test initiation and monitoring
- Endpoint determination criteria
- Result recording
Acceptance Criteria
Define pass/fail criteria based on:
- Product specifications
- Pharmacopeial requirements
- Individual tablet vs. batch criteria
Documentation Requirements
Test Records
- Date and time of testing
- Sample identification
- Operator identification
- Equipment used (with calibration status)
- Results and observations
Deviation Handling
Procedures for:
- Out-of-specification results
- Equipment malfunctions
- Retesting criteria
Training Requirements
Ensure all operators are trained on:
- Equipment operation
- SOP procedures
- Safety precautions
- Documentation requirements