Standard Operating Procedure for in-process Friability Testing
Purpose
The purpose of this SOP is to outline the procedures for conducting friability testing during the tablet manufacturing process to assess the durability and quality of tablets.
Scope
This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for friability testing.
Responsibilities
- Quality Control Analysts: Conducting friability 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
- Weigh a predetermined amount of tablets and place them in the friability testing apparatus.
- Operate the apparatus according to manufacturer instructions to subject the tablets to mechanical stress.
- After the test cycle, remove the tablets and gently remove any loose dust or debris.
- Weigh the tablets again and calculate the percentage of weight loss.
- Compare the percentage of weight loss against acceptance criteria.
- Document all testing procedures, observations, and results accurately and thoroughly.
- 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
- Friability 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
