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:
- To provide participants with a comprehensive understanding of Good Manufacturing Practice (GMP) principles and their applications.
- To familiarize participants with global GMP regulations and guidelines.
- To develop skills for maintaining GMP compliance in manufacturing environments.
- To enhance participants' ability to identify and mitigate risks in GMP-regulated processes.
Learning Outcomes:
Upon completing this course, participants will be able to:
- Explain the principles and importance of GMP in manufacturing industries.
- Identify key regulatory requirements and implement them in manufacturing processes.
- Maintain GMP-compliant facilities, equipment, and documentation.
- Demonstrate best practices in personnel hygiene, training, and contamination control.
- Develop and implement quality assurance processes, including SOPs and CAPA systems.
- Prepare for and respond to GMP audits and inspections effectively.
- Apply risk management tools to ensure product quality and safety.
- 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.