SOP for Validation Protocols (Installation Qualification, Operational Qualification, Performance Qualification)

1) Purpose

To define the procedures for conducting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure that equipment, systems, and processes meet predefined acceptance criteria and comply with regulatory requirements in pharmaceutical manufacturing.

2) Scope

This SOP applies to all validation activities involving equipment, systems, and processes within the pharmaceutical manufacturing facility, including new installations, modifications, and revalidation.

3) Responsibilities

Validation Team: Responsible for executing IQ, OQ, and PQ protocols.
Quality Assurance: Responsible for overseeing validation activities and ensuring compliance with regulatory standards.
Engineering: Responsible for coordinating equipment installation and qualification.
Manufacturing: Responsible for providing support and resources during validation activities.

4) Procedure

1. Installation Qualification (IQ):
   1. Verify equipment installation as per manufacturer specifications and site requirements.
   2. Check and record equipment dimensions, utilities, and connections.
   3. Verify documentation, including manuals, drawings, and certificates.
   4. Perform a walk-through inspection of the installation.
2. Operational Qualification (OQ):
   1. Verify equipment operation under normal operating conditions.
   2. Test equipment functionality and performance against predefined criteria.
   3. Perform calibration checks and verify control systems.
   4. Document test results and deviations encountered during testing.
3. Performance Qualification (PQ):
   1. Conduct equipment performance tests using production materials.
   2. Verify equipment’s ability to consistently produce acceptable product outputs.
   3. Perform worst-case scenario tests and simulate routine production conditions.
   4. Review and approve PQ protocol and test results.

5) Abbreviations, if any

IQ – Installation Qualification

OQ – Operational Qualification

PQ – Performance Qualification

6) Documents, if any

• IQ, OQ, PQ Protocols
• Test Scripts and Checklists
• Calibration Certificates
• Deviation Reports

7) Reference, if any

ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0