Standard Operating Procedure for Equipment Validation (IQ/OQ/PQ)

1) Purpose

The purpose of this SOP is to establish the procedures for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment used in the pharmaceutical industry to ensure they meet required specifications and regulatory standards.

2) Scope

This SOP applies to all new and existing equipment that requires validation in the pharmaceutical manufacturing process.

3) Responsibilities

The Quality Assurance and Validation Departments are responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Installation Qualification (IQ)
   1. Verify that the equipment is installed according to manufacturer specifications and site requirements.
   2. Document the installation process, including utility connections, environmental conditions, and component verification.
   3. Ensure all necessary documentation, such as manuals and certificates, are available and complete.
2. Operational Qualification (OQ)
   1. Develop and approve an OQ protocol that outlines the tests to be performed to verify equipment operation.
   2. Conduct tests to ensure the equipment operates according to predefined specifications under normal operating conditions.
   3. Document test results, any deviations, and corrective actions taken.
3. Performance Qualification (PQ)
   1. Develop and approve a PQ protocol that outlines the tests to be performed to verify equipment performance under actual production conditions.
   2. Conduct tests to ensure the equipment consistently performs as intended during routine use.
   3. Document test results, any deviations, and corrective actions taken.
4. Review and Approval
   1. Review all validation documentation to ensure completeness and accuracy.
   2. Approve the validation process and document the approval with signatures from relevant personnel.

5) Abbreviations, if any

IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification

6) Documents, if any

Validation Protocols, Validation Reports, Equipment Manuals, Installation Checklists

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0