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