Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) Training Course

Module 1: Introduction to GMP

• Overview of GMP principles and guidelines
• History and evolution of GMP regulations
• Importance of GMP in manufacturing industries
• Regulatory authorities and standards (e.g., FDA, WHO, EU GMP)

Module 2: GMP Standards and Regulations

• Key regulations and guidelines (CFR Title 21, EU GMP Guidelines, WHO GMP)
• Understanding quality management systems
• Documentation and record-keeping requirements
• Common industry-specific applications (e.g., pharmaceuticals, food, cosmetics)

Module 3: Facilities and Equipment

• GMP-compliant facility design and layout
• Equipment qualification and maintenance
• Cleanroom requirements and classifications
• Environmental monitoring and control

Module 4: Personnel and Training

• Roles and responsibilities in GMP compliance
• Importance of staff training and development
• Personal hygiene and health requirements
• Preventing contamination and cross-contamination

Module 5: Quality Assurance (QA) and Quality Control (QC)

• Distinction between QA and QC
• Developing and implementing standard operating procedures (SOPs)
• Handling deviations, CAPA (Corrective and Preventive Actions)
• Batch record review and product release

Module 6: GMP Audits and Inspections

• Preparing for regulatory audits and inspections
• Conducting internal audits
• Addressing audit findings and implementing corrective actions
• Continuous improvement in GMP compliance

Module 7: Risk Management in GMP

• Principles of risk assessment (ICH Q9)
• Risk management tools and techniques
• Identifying and mitigating risks in manufacturing processes

Module 8: Case Studies and Practical Applications

• Real-world examples of GMP violations and lessons learned
• Hands-on exercises: developing SOPs, conducting mock audits
• Group discussions and Q&A sessions

Course Objectives:

1. To provide participants with a comprehensive understanding of Good Manufacturing Practice (GMP) principles and their applications.
2. To familiarize participants with global GMP regulations and guidelines.
3. To develop skills for maintaining GMP compliance in manufacturing environments.
4. To enhance participants' ability to identify and mitigate risks in GMP-regulated processes.

Learning Outcomes:

Upon completing this course, participants will be able to:

1. Explain the principles and importance of GMP in manufacturing industries.
2. Identify key regulatory requirements and implement them in manufacturing processes.
3. Maintain GMP-compliant facilities, equipment, and documentation.
4. Demonstrate best practices in personnel hygiene, training, and contamination control.
5. Develop and implement quality assurance processes, including SOPs and CAPA systems.
6. Prepare for and respond to GMP audits and inspections effectively.
7. Apply risk management tools to ensure product quality and safety.
8. Analyze case studies to learn from real-world GMP challenges.

Methodology:

• Interactive Lectures: Engaging presentations with visual aids and real-world examples.
• Case Studies: Analysis of GMP compliance issues and solutions.
• Group Activities: Team exercises for developing SOPs and conducting mock audits.
• Hands-On Workshops: Practical sessions on documentation and risk assessment.
• Assessments: Quizzes, group presentations, and individual assignments to evaluate understanding.
• Q&A Sessions: Open forums for participants to address specific challenges and clarify doubts.