Standard Operating Procedure for Equipment Maintenance
1) Purpose
The purpose of this SOP is to establish a procedure for the maintenance of equipment used in the manufacturing and testing of pharmaceutical products to ensure proper functionality and compliance.
2) Scope
This SOP applies to all equipment used within the manufacturing and quality control departments.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Equipment Operators:
Responsible for performing routine maintenance tasks and reporting any issues.
3.2 Maintenance Team:
Responsible for performing scheduled and corrective maintenance activities.
3.3 Quality Assurance (QA) Manager:
Responsible for overseeing the maintenance process and ensuring compliance with regulatory requirements.
4) Procedure
4.1 Identification of Equipment:
4.1.1 Maintain a master list of all equipment used in manufacturing and testing.
4.1.2 Label each piece of equipment with a unique identification number.
4.2 Scheduling Maintenance:
4.2.1 Develop a maintenance schedule based on the manufacturer’s recommendations and regulatory requirements.
4.2.2 Notify relevant departments of upcoming maintenance activities.
4.3 Routine Maintenance:
4.3.1 Perform daily, weekly, and monthly maintenance tasks as specified in the equipment’s operation manual.
4.3.2 Record maintenance activities in the equipment’s maintenance log.
4.3.3 Inspect equipment for signs of wear and tear and replace parts as needed.
4.4 Corrective Maintenance:
4.4.1 Address equipment issues reported by operators or identified during routine maintenance.
4.4.2
4.4.3 Document all corrective maintenance activities in the equipment’s maintenance log.
4.5 Documentation and Review:
4.5.1 Document all maintenance activities, including routine and corrective maintenance, in the equipment’s maintenance log.
4.5.2 Review maintenance logs regularly to ensure compliance with maintenance schedules and identify recurring issues.
4.5.3 Approve equipment for use only if it meets the required specifications after maintenance.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Maintenance Logs
2. Equipment Operation Manuals
3. Maintenance Schedules
7) Reference, if any
1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ISO 9001 Quality Management Systems – Requirements
8) SOP Version
Version 1.0
