Beginner
GMP
GMP (Good Manufacturing Practices)
- 18h Duration
- Introduction to GMP
- Definition of GMP (Good Manufacturing Practices)
- Importance of GMP in product quality and safety
- Regulatory requirements and global standards
- Overview of industries applying GMP (food, pharma, cosmetics)
- Objectives of GMP
- Ensuring product safety and quality
- Compliance with regulatory requirements
- Minimizing risks in production
- Building customer trust and market access
- GMP Principles
- Hygiene and sanitation
- Prevention of contamination (physical, chemical, biological)
- Documentation and record keeping
- Traceability and recall systems
- Quality control and assurance
- Personnel Hygiene and Practices
- Personal hygiene requirements
- Protective clothing and PPE
- Health status and medical checks
- Employee training and awareness
- Behavior inside production areas
- Facility and Equipment Requirements
- Layout and design of facilities
- Maintenance and cleaning procedures
- Equipment calibration and validation
- Utilities (water, air, electricity) control
- Pest control systems
- Cleaning and Sanitation
- Cleaning procedures and schedules
- Types of cleaning agents and disinfectants
- Cleaning validation
- Cross-contamination prevention
- Documentation and Record Keeping
- Types of GMP documents (SOPs, records, logs)
- Good documentation practices (GDP)
- Document control and retention
- Common documentation errors
- Production and Process Control
- Raw material control and supplier approval
- Handling and storage requirements
- In-process controls
- Packaging and labeling
- Product release procedures
- Quality Control and Quality Assurance
- Role of QC and QA
- Testing and inspection
- Handling non-conforming products
- Corrective and preventive actions (CAPA)
- Risk Management
- Introduction to risk-based thinking
- Identifying hazards and risks
- Risk assessment tools
- Risk control measures
- Deviation and Change Control
- Handling deviations
- Root cause analysis
- Change control procedures
- Continuous improvement
- Internal Audits and Inspections
- Purpose of GMP audits
- Types of audits
- Audit planning and execution
- Reporting and follow-up
- Product Recall and Complaint Handling
- Recall procedures
- Complaint management system
- Investigation and corrective actions
- Regulatory Compliance
- Overview of international GMP guidelines
- Inspection readiness
- Dealing with regulatory authorities
- Practical Session / Case Studies
- Real-life GMP violations
- Group discussions
- Problem-solving exercises
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