Standard Operating Procedure for Equipment Breakdown and Repair Procedures
1) Purpose
The purpose of this SOP is to establish procedures for managing equipment breakdowns, initiating repair activities, and restoring equipment functionality in the manufacturing of dental dosage forms.
2) Scope
This SOP applies to all equipment breakdowns and repair activities conducted for manufacturing equipment used in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for promptly reporting equipment breakdowns and coordinating repair activities. The Maintenance Department is responsible for executing equipment repairs and ensuring equipment functionality.
4) Procedure
4.1 Equipment Breakdown Reporting
4.1.1 Immediately notify the Maintenance Department and Production Supervisor of any equipment breakdowns.
4.1.2 Provide detailed information on the nature of the breakdown, affected equipment, and any initial observations.
4.2 Initial Assessment
4.2.1 Conduct an initial assessment to determine the cause and severity of the equipment breakdown.
4.2.2 Identify potential impacts on production schedules and product quality.
4.3 Repair Authorization
4.3.1 Obtain authorization from the Production Supervisor and Maintenance Manager to proceed with equipment repairs.
4.3.2 Document repair authorization details, including approval signatures and timestamps.
4.4 Equipment Repair
4.4.1 Assign qualified maintenance personnel to perform equipment repairs based on the nature of the breakdown.
4.4.2 Follow documented repair procedures and
4.5 Testing and Validation
4.5.1 Conduct functional testing and validation of repaired equipment to ensure proper functionality and adherence to performance specifications.
4.5.2 Document testing results and ensure equipment meets predefined acceptance criteria.
4.6 Post-Repair Review
4.6.1 Review post-repair performance of equipment during initial production runs to verify stability and reliability.
4.6.2 Address any residual issues or adjustments needed following equipment repair.
5) Abbreviations, if any
SOP – Standard Operating Procedure
6) Documents, if any
Equipment Breakdown Reports
Repair Authorization Forms
Equipment Maintenance Logs
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Company-specific equipment maintenance and repair policies
8) SOP Version
Version 1.0