Application Guide to the ISO 14644 Series for the Pharmaceutical Industry
Application Guide to the ISO 14644 Series for the Pharmaceutical Industry
The definitive guide to understanding and applying the complete ISO 14644 series, from Part 1 to the brand-new Part 21, with direct reference to GMP Annex 1 requirements.
An operational manual that turns theory into practical tools for the qualification, monitoring, and management of pharmaceutical cleanrooms.
👉 Includes explanations, examples, and tables for all sections of the standard:
ISO 14644-1 → 2 → 3: classification, monitoring, and test methods
ISO 14644-4 → 6: design, operations, and technical vocabulary
ISO 14644-7 → 20: separative devices, surfaces, chemical contamination, equipment, and materials
ISO/TR 14644-21 (2023): the latest particle sampling techniques
With direct connections to GMP Annex 1 (EMA), FDA Guidance, WHO GMP, and PIC/S.
Inside you’ll find:
- Clear, up-to-date explanations for every part of the ISO 14644 series
- Operational checklists to implement and maintain compliance
- Practical examples, comparative charts, and ISO ↔ GMP Grade tables
- Ready-to-use tools for audits, inspections, and environmental qualification
Perfect for:
QA Managers, Qualified Persons, Validation & Calibration Experts, Production Managers, Regulatory Affairs Officers, and all professionals involved in contamination control.
📘 Format: Digital PDF (instant download)
📅 Version: 1.0 – August 2025
📄 Pages: 66
🔒 For personal or corporate use – all rights reserved GuideGxP.com
Available 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.