ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)
ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)
The ISO 14644-5:2025 Operational Guide by GuideGxP is the practical reference for the operational implementation of ISO 14644-5 in controlled contamination environments.
Designed for pharmaceutical cleanrooms, medical device manufacturing and controlled environments, this guide translates regulatory requirements into applicable procedures, operational checklists and audit-ready tools, aligned with the latest inspection expectations.
ISO 14644-5:2025 Guide: from the standard to operational practice
The new ISO 14644-5:2025 introduces a structured, risk-based approach to cleanroom management, with a clear focus on:
- Operations Control Programme (OCP)
- documented control of operations
- integration with Quality Risk Management (ICH Q9)
- alignment with the Contamination Control Strategy (CCS – EU GMP Annex 1)
This guide is designed to help professionals demonstrate effective operational control of cleanrooms during audits and inspections, avoiding ambiguous interpretations of the standard.
Key contents of the ISO 14644-5 guide
Inside the guide you will find:
Comprehensive analysis of ISO 14644-5:2025 updates vs ISO 14644-5:2004
Operational explanation of the Operations Control Programme (OCP)
Practical management of:
- personnel and behaviour in cleanrooms
- gowning and training
- material and equipment flows
- cleaning and sanitisation
- maintenance and calibration
- environmental monitoring
- The most frequent issues identified during ISO audits and GMP inspections, and how to prevent them
The 6 ISO 14644-5 operational checklists (audit-ready)
The guide includes 6 ready-to-use checklists, ideal for gap analysis, internal audits and inspection readiness:
- Operations Control Programme (OCP) Checklist
- Impact Assessment & Change Control Checklist
- Cleanroom Cleaning & Sanitisation Checklist
- Cleanroom Personnel Training Checklist
- Maintenance & Calibration Checklist
- Environmental Monitoring Checklist
Who this ISO 14644-5 guide is for
- QA Manager / QA Officer
- Cleanroom Manager
- Facility & Engineering Manager
- Validation & Calibration Specialists
- Pharma and Medical Device professionals
Why purchase this ISO 14644-5 guide?
- Supports ISO 14644-5:2025 compliance
- Reduces the risk of audit findings
- Enables the development of a robust and defensible OCP
- Facilitates alignment with EU GMP Annex 1
- Provides practical tools that can be applied immediately
Product details
- Format: Professional PDF
- Length: 109 pages
- Last update: February 2026
- Languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.