Standard Operating Procedure for Equipment Qualification in Creams Production

1) Purpose

The purpose of this SOP is to establish guidelines and procedures for the qualification of equipment used in creams production to ensure it operates consistently and produces products meeting predetermined specifications.

2) Scope

This SOP applies to all equipment used in the manufacturing, filling, packaging, and storage of creams in the production facility.

3) Responsibilities

The Engineering and Maintenance department is responsible for performing equipment qualification activities. The Quality Assurance (QA) department is responsible for reviewing and approving qualification protocols and reports.

4) Procedure

4.1 Equipment Qualification Phases

4.1.1 Qualification activities are divided into four phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

4.2 Design Qualification (DQ)

4.2.1 Ensure that the design of the equipment meets the required specifications and complies with regulatory standards.

4.2.2 Review and approve design specifications and documents.

4.3 Installation Qualification (IQ)

4.3.1 Verify that the equipment is installed according to manufacturer’s specifications and site requirements.

4.3.2 Document the installation process, including utilities connections, environmental conditions, and safety features.

4.3.3 Perform calibration of all measuring instruments associated with the equipment.

4.4 Operational Qualification (OQ)

4.4.1 Test the equipment to ensure it operates according to the operational specifications and tolerances.

4.4.2 Conduct functional