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 tests, including operating controls, alarms, and interlocks.
4.4.3 Document all test results and deviations, if any, and perform corrective actions as necessary.
4.5 Performance Qualification (PQ)
4.5.1 Validate that the equipment performs consistently and produces a product that meets predetermined quality attributes under normal operating conditions.
4.5.2 Conduct performance tests under actual production conditions and document the results.
4.5.3 Review and approve the PQ report.
4.6 Requalification
4.6.1 Perform requalification activities when major changes are made to the equipment or its environment, or as part of a periodic review.
4.6.2 Follow the same procedures as for initial qualification (IQ, OQ, PQ).
4.7 Documentation
4.7.1 Maintain all qualification protocols, reports, and related documents in a secure and organized manner.
4.7.2 Ensure that qualification documents are reviewed and approved by the QA department.
5) Abbreviations, if any
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
QA: Quality Assurance
6) Documents, if any
Equipment Qualification Protocols
Installation Records
Operational Test Records
Performance Test Records
Calibration Certificates
7) Reference, if any
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0