E03-8001 EQUIPMENT QUALIFICATION PROCEDURE

Description

What is Equipment Qualification?

The design, construction and delivery of manufacturing systems and equipment into a facility requires a systematic approach in order to meet the user requirements and that of the relevant authorities like cGMP, local governing codes, law and regulations.

Equipment Qualification is the action of proving and documenting that equipment and ancillary systems are properly installed, work correctly, and actually lead to the expected results. This is to ensure that all critical aspects or acceptance criteria for its intended use are met. Qualification is part of the validation process, a regulatory compliance requirement.

What is this document about?

The purpose of this SOP is to outline the procedures for performing Equipment Qualification of equipment and piping.

The three components of the Equipment Qualification are:

• Installation Qualification (IQ) – documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements.  Source: PIC/S
• Operational Qualification (OQ) – documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges. Source: PIC/S
• Performance Qualification (PQ) – documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. Source: PIC/S

This document is the Standard Operating Procedure for Equipment Qualification and does not include the IQ, OQ or PQ protocol templates

This procedure plays a role in two areas:

• GEP – is part of the Testing process in a Project Quality System (see flowchart below)
• QMS – is a component of Facility & Equipment under Resource Requirements (refer QMS Flowchart)

This well proven document has been used in numerous GMP facilities

The document has two Parts (a) introduction to template – 4 pages (b) a 8-page template + attachments

Attachments & Forms included:

• E03-80-01F1 Qualification Summary Report (4 pages) – guides you through what is to be included in the report
• E03-80-01F2 Protocol Variance Report Form (2 pages) – it guides you through a typical deviation investigation and CAPA process to close the variance

It includes a process map of the sequence of events from design, impact assessment to qualification

Both prospective and retrospective qualifications are included

To view and PRINT the above flowchart in PDF format – E03-50-00_Project_Quality_Sys_Flowchart

Associated Industry/regulatory guidance and requirements:

• ISPE Baseline Guide – Commissioning and Qualification
• FDA CFR Part 211 Subpart C (Building and Facilities) and Subpart D (Equipment)
• PIC/S Guide to GMP for Medicinal Products Part I (Clause 1.4/xi) and II (12.3 Qualification)
• ASTM E2500 Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing System and Equipment

Included Sections:

Purpose, Scope, References and Associated Documents, Definitions /Acronyms, Responsibility, Procedures, Attachments.

Keywords:

Equipment Qualification Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

Who needs this document?

• Vendors – equipment fabricators and manufacturers; mechanical piping contractors
• Any department who uses equipment & utilities in R&D, manufacturing, testing, laboratories.
• Projects, Validation, Engineering department
• Quality Control
• Manufacturing

Related Documents:

E03-50-00 Project Quality System Flowchart

E03-50-01 Project Quality System Policy

E03-50-02 Project Change Control

E03-50-03 Project & Quality Plan (Concise)

E03-50-04 Project Construction Checklist

E03-51-01 Project Documentation & Testing Requirements

E03-52-01 Material of Construction Specification

E03-53-01 Project Procurement & Inspection Procedure

E03-54-01 Preparation & Welding of Critical Piping

E03-54-02 Passivation of Stainless Steel & Record Form

EQUIPMENT TESTING & QUALIFICATION:

E03-55-01 Inspection & Test Plan (Form)

E03-55-02 Welding – Dye Penetrant Inspection Procedure & Record Form

E03-55-03 Piping Hydrostatic Test Procedure & Form

E03-60-XX Pre-Commissioning Checklist – various equipment

E03-60-01 Pre-Commissioning Checklist – Pump (Centrifugal)

E03-80-01 Equipment Qualification SOP – this document

E03-80-01F1 Qualification Summary Report

E03-80-01F2 Protocol Variance Report Form

E03-81-01 IQ Protocol Template

E03-82-01 IQ Protocol Template For Ancillary Equipment

E03-83-01 OQ Protocol Template

E03-84-01 PQ Protocol Template

E02-90-01 Project Handover – O&M Manual