Water Purification

Water Purification, Storage & Distribution System Qualification and Validation

Master Design, Compliance and Validation of Pharmaceutical Water Systems

This course covers the design, qualification, operation, and validation of pharmaceutical water systems, including Purified Water (PW), Water for Injection (WFI), Pure Steam, and their distribution systems. Participants gain complete technical and regulatory understanding of water treatment technologies, qualification lifecycle, microbial control, commissioning requirements, and documentation expectations to ensure system reliability and compliance with global GMP standards.
The course also highlights common gaps between engineering design and GMP execution, enabling participants to evaluate vendor deliverables, improve water system performance, and prepare confidently for internal and external inspections.

Who Should Attend

Qualification & Validation Engineers / Managers

Water System Design & Maintenance Personnel

Process / Project Engineers involved in water system upgrades or renovations

Quality Control Laboratory Specialists

Microbiology and Environmental Monitoring Specialists

QA / Documentation / Regulatory Personnel

Production Supervisors and Managers using water systems

Vendor / Service Provider Personnel responsible for pharmaceutical water systems

Internal / External Quality Auditors

Learning Objectives

By the end of this course, participants will be able to:

Understand GMP fundamentals for pharmaceutical water systems in sterile & non-sterile industries

Identify critical design requirements for PW, WFI and Pure Steam generation & distribution

Plan and execute qualification lifecycle: URS → DQ → IQ → OQ → PQ

Apply commissioning requirements before starting qualification

Understand piping and engineering considerations for contamination prevention & sanitization

Apply water testing, microbiological monitoring and trending strategies

Distinguish between design parameters and regulatory compliance parameters

Prepare, review and maintain water system validation documentation

Communicate effectively with inspection teams regarding water system performance and compliance

Course Outline / Training Topics

GMP fundamentals of pharmaceutical water systems

Introduction to water treatment systems (Planning)

Water system specifications and commercial requirements

Water quality standards and pharmacopeia testing

Water treatment design and components (pre-treatment systems)

Water purification system design (RO, EDI, UV and others)

Water storage & distribution system

Biofilm formation and microbial control

Qualification Protocols / Reports:

User Requirement Specifications (URS)

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ – 3 phases)

Change control and requalification

Regulatory expectations and guidelines for pharmaceutical water systems

Engineering best practices for water system applications

Workshop for impact assessment

Real case pictures and videos presented during the course

Duration

Three days

Key Takeaways

End-to-end competence in water system qualification and validation

Improved understanding of regulatory expectations and inspection behavior

Ability to evaluate vendor designs and documentation from a compliance perspective

Confidence in managing biofilm control, microbial monitoring, and trending

Strong capability to prepare and maintain accurate validation files throughout the lifecycle

Speak to a Training Specialist

Contact

Building #10, Ground Floor, Business Park, Amman, Jordan
+962 (79) 1533337
m.abuzour@agonme.com

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Services

Management Representative

Training Programs

Water Purification