Standard Operating Procedure for Equipment Logbook Maintenance
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance of equipment logbooks used in the manufacturing of dental dosage forms, ensuring accurate recording of equipment activities and compliance with regulatory standards.
2) Scope
This SOP applies to all equipment logbooks maintained 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 maintaining equipment logbooks. The Quality Assurance (QA) Department is responsible for reviewing logbook entries periodically to ensure completeness and accuracy.
4) Procedure
4.1 Logbook Setup and Entries
4.1.1 Assign a dedicated logbook for each piece of manufacturing equipment.
4.1.2 Enter equipment identification details, including name, model, and location, in the logbook header.
4.2 Daily Operations Recording
4.2.1 Record daily operational activities, including start-up, shutdown, cleaning, maintenance, and calibration, in the logbook.
4.2.2 Document any deviations, incidents, or abnormalities encountered during equipment operations.
4.3 Calibration and Maintenance Records
4.3.1 Log calibration and maintenance activities performed on equipment, including dates, personnel involved, and results.
4.3.2 Attach calibration and maintenance certificates or reports to the logbook entries as applicable.
4.4 Equipment Changeover Records
4.4.1 Document equipment changeover procedures and associated activities in the logbook.
4.4.2 Record the start and end times of changeover operations, including cleaning and setup activities.
4.5 Review and Approval
4.5.1 Review logbook entries regularly to ensure completeness, accuracy, and compliance with procedures.
4.5.2 Approve logbook entries and sign off to confirm review by authorized personnel.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Equipment Logbooks
Calibration and Maintenance Reports
Changeover Procedures
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Company-specific equipment logbook policies
8) SOP Version
Version 1.0