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10 Golden Rules of GMP Course & Certification
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About
The 10 Golden Rules of GMP Course & Certification is designed to provide a practical understanding of Good Manufacturing Practice (GMP) principles essential for ensuring product quality, safety, and regulatory compliance in pharmaceutical and life sciences industries. The course focuses on the core behaviors and standards that support consistent, high-quality manufacturing practices.
This course covers the 10 key GMP principles, documentation practices, hygiene standards, deviation management, contamination control, equipment and process integrity, training requirements, and regulatory expectations. It also emphasizes quality culture, inspection readiness, and best practices for maintaining GMP compliance in regulated environments. Upon successful completion, learners receive a certification demonstrating competency in GMP fundamentals.
Who Should Enrol?
- Pharmaceutical Manufacturing Professionals
- Quality Assurance and Quality Control Teams
- Production and Operations Staff
- Regulatory Affairs Professionals
- Clinical Supply and Packaging Teams
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, and Engineering Graduates
What you will learn
Understand the core principles of Good Manufacturing Practice (GMP) through the 10 Golden Rules, including facility design, process validation, and procedural compliance.
Learn the importance of documentation, clear roles and responsibilities, and effective training in maintaining GMP compliance.
Gain knowledge of essential operational practices such as hygiene, equipment maintenance, lifecycle quality management, and controlled manufacturing environments.
Develop an understanding of continuous compliance through audits, inspections, and a strong quality-focused culture across all GMP activities.
Course Syllabus
- What 'Facility Design' Means in GMP
- Why This Rule Exists
- The Principle of Segregation
- EU GMP Cleanroom Grades
- Unidirectional Flow
- Cleanroom Classification (EU Annex 1)
- HVAC and Pressure Cascades
- Surfaces, Finishes, and Cleanability
- Material and Personnel Airlocks
- Water Systems by Design
- FDA Expectations
- EU GMP Expectations
- What Process Validation Means
- Why This Rule Exists
- The Three Stages of Process Validation
- Three-Stage Validation Lifecycle
- Critical Quality Attributes (CQAs)
- Critical Process Parameters (CPPs)
- Quality by Design (QbD)
- Process Performance Qualification (PPQ)
- Continued Process Verification (CPV)
- Cleaning Validation
- Sterilisation and Aseptic Process Validation
- Analytical Method Validation
- FDA Expectations
- EU GMP Expectations (Annex 15)
- What 'Good Procedures' Means
- Why This Rule Exists
- Hierarchy of Documents
- Anatomy of a Good SOP
- Plain Language Principles
- Version Control and Change History
- Periodic Review
- Procedure Approval Workflow
- Training to SOPs
- Following the Procedure
- Deviation Management
- FDA Expectations
- EU GMP Expectations
- Why Roles Matter in GMP
- The Quality Unit
- The Qualified Person (EU)
- Manufacturing Roles
- Quality Roles
- Materials and Logistics Roles
- RACI in Practice
- Job Descriptions and GMP
- Authority and Decision Rights
- Segregation of Duties
- FDA Expectations
- EU GMP Expectations
- Why Documentation Is Critical
- If It's Not Documented, It Didn't Happen
- Types of GMP Records
- ALCOA+ Data Integrity Principles
- Batch Record Expectations
- ALCOA+ Principles
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Beyond ALCOA: Complete, Consistent, Enduring, Available
- Electronic Records and Audit Trails
- FDA Expectations
- EU GMP Expectations
- Why Training Is a GMP Pillar
- Training Lifecycle
- Competency vs. Awareness
- Training Needs Assessment
- Effective Training Methods
- On-the-Job Training (OJT)
- Training Records
- Training Effectiveness
- Refresher Training
- Cross-Training and Multi-Skilling
- Leadership and Quality Culture Training
- FDA Expectations
- EU GMP Expectations
- Why Hygiene Matters in GMP
- Personnel Hygiene Fundamentals
- Gowning Standards
- Aseptic Gowning
- Hand Hygiene
- Cleaning and Disinfection
- Environmental Monitoring (EM)
- Health and Behaviour Controls
- Visitor and Contractor Hygiene
- Material Hygiene
- Pest Control
- FDA Expectations
- EU GMP Expectations (Annex 1)
- Why Maintenance Is GMP
- Asset and Equipment Lifecycle
- Preventive Maintenance (PM)
- Root Cause Analysis Tools
- Calibration Programme
- Corrective Maintenance
- Change Control for Equipment
- Computerised Systems Maintenance
- Spare Parts Management
- Facility Maintenance
- Documentation of Maintenance
- Reliability and Risk-Based Maintenance
- FDA Expectations
- EU GMP Expectations
- What 'Quality Lifecycle' Means
- Why Lifecycle Quality Matters
- The Pharmaceutical Quality System (PQS)
- ICH Q10 Pharmaceutical Quality System
- Quality Risk Management (ICH Q9)
- Quality by Design (ICH Q8)
- Technology Transfer
- Change Management
- Deviation and CAPA Systems
- Annual Product Review (APR/PQR)
- Stability and Shelf-Life
- Pharmacovigilance and Complaints
- Supplier and Outsourced Quality
- FDA Expectations
- EU GMP Expectations
- Why Audits Are GMP
- Types of Audits
- Self-Inspection Programme
- Inspection Findings Severity
- Audit Planning
- Conducting an Audit
- Findings Classification
- Responding to Findings
- CAPA from Audits
- Inspection Readiness
- Inspection Day
- Behaviours During Inspection
- FDA Expectations
- EU GMP Expectations
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to 21 CFR 210/211, EudraLex Volume 4 (EU GMP), WHO GMP, and PIC/S inspection guidance as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by industry practitioners and subject-matter experts to ensure that learners can apply the principles directly in their daily work. Every module follows a consistent rhythm — concept, regulatory context, real-world failure, audit perspective, preventive controls, and a knowledge check.
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