Foundations of Cleaning Validation in Pharma
Foundations of Cleaning Validation in Pharma
Version 1.0
Released on 28/10/2025
A foundational online course on cleaning validation in pharmaceutical manufacturing—covering GMP principles, lifecycle steps, and global regulatory expectations for safe, compliant, and effective cleaning processes.
- English
- Available on app
- + Certificate
Version 1.0
Released on 28/10/2025
Foundations of Cleaning Validation in Pharma
Released on 28/10/2025
- beginner
- + Certificate
- Available on app
- Online at your own pace
- Shareable certificate of completion
About the Foundations of Cleaning Validation in Pharma
Learn how pharmaceutical manufacturers ensure product quality and patient safety through effective cleaning validation. This foundational eLearning course explains the principles, lifecycle, and documentation requirements of cleaning validation within Good Manufacturing Practice (GMP).
You’ll explore contamination risks, equipment and surface types, residue limits, and regulatory expectations under EMA, FDA, PIC/S, and WHO guidelines. Designed for QA, QC, and production professionals, the course builds a clear understanding of how cleaning validation supports inspection readiness and continuous compliance.
Developed by European GMP experts, it aligns with EU regulatory frameworks and current industry standards, helping learners apply best practices directly to real manufacturing environments.
ISO 9001
Quality Management System
Certificate Registration No.: 12 100 60610 TMSPharmuni Certificate
Zamann Pharma Support GmbH
Personnel qualification in the field of pharmacy, medical technology and quality assurance.
Consulting service in the field of pharmacy, medical technology and quality assurance.
Your Learning Objectives
This course provides a practical introduction to one of the most essential quality assurance activities in pharmaceutical manufacturing, cleaning validation. Whether you are new to GMP environments or want to strengthen your understanding of compliance expectations, this course will give you the fundamental knowledge you need to understand how and why cleaning processes are validated. By the end of this course you will be able to:
Learning Objective 1
Explain how cleaning validation supports compliance with GMP regulations under EMA, FDA, PIC/S, and ICH Q7, and why it is essential for product quality and patient safety.
Learning Objective 2
Differentiate between key types of contamination risks (cross-contamination, microbial, endotoxin, particulate) and describe how common cleaning methods (manual, automated, CIP/SIP) control these risks in manufacturing.
Learning Objective 3
Identify typical equipment and surface types that require cleaning validation and describe how material and design features affect cleanability.
Learning Objective 4
Define essential cleaning validation terminology and acronyms (e.g. MACO, HBEL, PDE, residue limits, lifecycle phases) used in regulatory documentation and inspections.
Learning Objective 5
Outline the key phases of the cleaning validation lifecycle, including process design, sampling, qualification, residue evaluation, and maintenance of validated status, in line with EMA Annex 15 and ICH Q9 (QRM) principles.
Learning Objective 6
Describe the main documents used in cleaning validation, including Validation Master Plans (VMPs), qualification protocols, and validation reports, and explain their role in demonstrating data integrity and audit readiness.
Learning Objective 7
Evaluate how regulatory expectations, site harmonization, and continuous improvement practices influence cleaning validation programs in global pharmaceutical operations.
Benefits of this Course
Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.
- Downloadable Resources
- Fast-Tracked Qualification
- Exclusive Assessment Quiz
- Skill Tree Levelup
- Customer Support
- Sharable & Downloadable Certification
FAQs
How do I enroll in the Foundations of Cleaning Validation in Pharma online course?
Create a free Pharmuni account from our registration page, open this course page and click “Start Learning” button on top of the page. You can start learning instantly from any device.
How do I complete the quiz and download my certificate?
Work through all lessons, then pass the short quiz with ≥ 80 %. When you pass, the Receive Certificate button appears on top of this page—click it to download your PDF certificate, and you’ll also find it later under My Certificates in your dashboard.
Is the Foundations of Cleaning Validation in Pharma certificate recognized, and how long is it valid?
Pharmuni certificates are backed by ISO 9001 of our mother company, Zamann Pharma Support, and are accepted by employers worldwide. Each certificate stays valid for two years from its issue date. You can learn more about our certificates here.
What career benefits will I gain from Foundations of Cleaning Validation in Pharma?
To create this course, we constantly monitor the job market. The course teaches job-ready skills, boosting your credibility for pharmaceutical roles, especially in Quality Management. Add the credential to LinkedIn or your CV to stand out in recruiter searches.
How long does Foundations of Cleaning Validation in Pharma take, and can I learn at my own pace?
All Pharmuni content is fully self-paced—study whenever it suits you. Most learners finish a module within one week, but there is no deadline as long as your subscription is active.
What if I don’t pass the quiz the first time?
No worries—you can retake the quiz (and the course) as many times as you need until you achieve the passing score and download your certificate.
How do I upgrade to Pharmuni Premium, and what extra perks do I get?
Log in, visit the Plans page and choose a Monthly or Annual plan in your local currency. Premium unlocks 45+ courses, ISO-9001 backed certificates, unlimited Skill-Tree access, a pharma CV & cover-letter builder, and a free 30-minute VIP career-coaching session every month.