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