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About

10 Golden Rules of GMP Practical Compliance & Audit Readiness is a ten-module programme that translates GMP from a regulatory burden into the daily discipline that protects patients. The course is built around ten interlocking rules facility design, process validation, written procedures, roles and responsibilities, records, training, hygiene, equipment maintenance, lifecycle quality, and regular auditing and pairs each rule with FDA, EU GMP, WHO, and PIC/S expectations, real recalls and Warning Letters, audit perspectives, and preventive controls. Every module ends with a practical scenario and a knowledge check.

10 Golden Rules of GMP is recommended for manufacturing operators, line leaders, shift supervisors, QA reviewers, engineering and maintenance staff, training coordinators, internal auditors, and new hires across pharmaceutical, biotech, and medical-device operations. On completion, learners can explain each Golden Rule in operational terms, recognise the typical failure modes that produce 483s and EU GMP findings, follow good documentation practices, escalate deviations early, work hygienically and protect product from contamination, support equipment maintenance and calibration, build quality into the process lifecycle, and prepare a site for routine and unannounced inspection.

Course Syllabus

  1. What 'Facility Design' Means in GMP
  2. Why This Rule Exists
  3. The Principle of Segregation
  4. EU GMP Cleanroom Grades
  5. Unidirectional Flow
  6. Cleanroom Classification (EU Annex 1)
  7. HVAC and Pressure Cascades
  8. Surfaces, Finishes, and Cleanability
  9. Material and Personnel Airlocks
  10. Water Systems by Design
  11. FDA Expectations
  12. EU GMP Expectations

  1. What Process Validation Means
  2. Why This Rule Exists
  3. The Three Stages of Process Validation
  4. Three-Stage Validation Lifecycle
  5. Critical Quality Attributes (CQAs)
  6. Critical Process Parameters (CPPs)
  7. Quality by Design (QbD)
  8. Process Performance Qualification (PPQ)
  9. Continued Process Verification (CPV)
  10. Cleaning Validation
  11. Sterilisation and Aseptic Process Validation
  12. Analytical Method Validation
  13. FDA Expectations
  14. EU GMP Expectations (Annex 15)

  1. What 'Good Procedures' Means
  2. Why This Rule Exists
  3. Hierarchy of Documents
  4. Anatomy of a Good SOP
  5. Plain Language Principles
  6. Version Control and Change History
  7. Periodic Review
  8. Procedure Approval Workflow
  9. Training to SOPs
  10. Following the Procedure
  11. Deviation Management
  12. FDA Expectations
  13. EU GMP Expectations

  1. Why Roles Matter in GMP
  2. The Quality Unit
  3. The Qualified Person (EU)
  4. Manufacturing Roles
  5. Quality Roles
  6. Materials and Logistics Roles
  7. RACI in Practice
  8. Job Descriptions and GMP
  9. Authority and Decision Rights
  10. Segregation of Duties
  11. FDA Expectations
  12. EU GMP Expectations

  1. Why Documentation Is Critical
  2. If It's Not Documented, It Didn't Happen
  3. Types of GMP Records
  4. ALCOA+ Data Integrity Principles
  5. Batch Record Expectations
  6. ALCOA+ Principles
  7. Attributable
  8. Legible
  9. Contemporaneous
  10. Original
  11. Accurate
  12. Beyond ALCOA: Complete, Consistent, Enduring, Available
  13. Electronic Records and Audit Trails
  14. FDA Expectations
  15. EU GMP Expectations

  1. Why Training Is a GMP Pillar
  2. Training Lifecycle
  3. Competency vs. Awareness
  4. Training Needs Assessment
  5. Effective Training Methods
  6. On-the-Job Training (OJT)
  7. Training Records
  8. Training Effectiveness
  9. Refresher Training
  10. Cross-Training and Multi-Skilling
  11. Leadership and Quality Culture Training
  12. FDA Expectations
  13. EU GMP Expectations

  1. Why Hygiene Matters in GMP
  2. Personnel Hygiene Fundamentals
  3. Gowning Standards
  4. Aseptic Gowning
  5. Hand Hygiene
  6. Cleaning and Disinfection
  7. Environmental Monitoring (EM)
  8. Health and Behaviour Controls
  9. Visitor and Contractor Hygiene
  10. Material Hygiene
  11. Pest Control
  12. FDA Expectations
  13. EU GMP Expectations (Annex 1)

  1. Why Maintenance Is GMP
  2. Asset and Equipment Lifecycle
  3. Preventive Maintenance (PM)
  4. Root Cause Analysis Tools
  5. Calibration Programme
  6. Corrective Maintenance
  7. Change Control for Equipment
  8. Computerised Systems Maintenance
  9. Spare Parts Management
  10. Facility Maintenance
  11. Documentation of Maintenance
  12. Reliability and Risk-Based Maintenance
  13. FDA Expectations
  14. EU GMP Expectations

  1. What 'Quality Lifecycle' Means
  2. Why Lifecycle Quality Matters
  3. The Pharmaceutical Quality System (PQS)
  4. ICH Q10 Pharmaceutical Quality System
  5. Quality Risk Management (ICH Q9)
  6. Quality by Design (ICH Q8)
  7. Technology Transfer
  8. Change Management
  9. Deviation and CAPA Systems
  10. Annual Product Review (APR/PQR)
  11. Stability and Shelf-Life
  12. Pharmacovigilance and Complaints
  13. Supplier and Outsourced Quality
  14. FDA Expectations
  15. EU GMP Expectations

  1. Why Audits Are GMP
  2. Types of Audits
  3. Self-Inspection Programme
  4. Inspection Findings Severity
  5. Audit Planning
  6. Conducting an Audit
  7. Findings Classification
  8. Responding to Findings
  9. CAPA from Audits
  10. Inspection Readiness
  11. Inspection Day
  12. Behaviours During Inspection
  13. FDA Expectations
  14. EU GMP Expectations

Course Benefits

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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.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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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.

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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.


Our Certified Customers

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