Topic |
Description |
Overview of GMP and GHP |
Definitions and importance, Regulatory frameworks and standards (e.g., Codex Alimentarius, ISO, FDA, etc.) |
GMP Principles |
Facility design and maintenance, Equipment hygiene and maintenance, Personnel hygiene and training |
GHP Principles |
Cleaning and sanitation practices, Pest control management, Raw material handling and storage |
Case Studies and Group Discussion |
Examples of GMP and GHP non-compliance and corrective actions |
Topic |
Description |
Implementing GMP and GHP in Daily Operations |
Documentation and record-keeping, Monitoring and verification processes |
Hazard Identification and Risk Management |
Types of hazards (biological, chemical, physical), Preventive measures |
Internal Auditing and Continuous Improvement |
Preparing for GMP/GHP audits, Handling non-conformities and corrective actions |
Workshop: Mock Audit and Role-Playing |
Conducting a mock GMP/GHP audit, Evaluating findings and reporting |
Feedback and Q&A Session |
Open discussion with participants |
Day 1 |
08:30 - 09:00 |
Registration and Opening Remarks |
Registration, Introductions |
Trainer/Host |
09:00 - 10:00 |
Overview of GMP and GHP |
Lecture and Q&A |
Trainer A |
10:00 - 10:15 |
Tea Break |
Networking |
- |
10:15 - 11:15 |
GMP Principles: Facility and Equipment |
Lecture and Case Studies |
Trainer B |
11:15 - 12:15 |
GMP Principles: Personnel Hygiene |
Group Discussion |
Trainer B |
12:15 - 01:15 |
Lunch Break |
- |
- |
01:15 - 02:15 |
GHP Principles: Cleaning and Sanitation |
Lecture and Activity |
Trainer A |
02:15 - 03:15 |
Pest Control and Raw Material Handling |
Interactive Session |
Trainer A |
03:15 - 03:30 |
Tea Break |
Networking |
- |
03:30 - 04:30 |
Case Studies and Group Discussion |
Group Activity |
Trainer A & B |
Day 2 |
08:30 - 09:30 |
Implementing GMP/GHP in Daily Operations |
Lecture |
Trainer B |
09:30 - 10:30 |
Hazard Identification and Risk Management |
Workshop |
Trainer A |
10:30 - 10:45 |
Tea Break |
Networking |
- |
10:45 - 12:00 |
Internal Auditing and Continuous Improvement |
Role-Playing Activity |
Trainer A & B |
12:00 - 01:00 |
Lunch Break |
- |
- |
01:00 - 02:30 |
Workshop: Mock Audit and Evaluation |
Group Activity |
Trainer A & B |
02:30 - 03:30 |
Feedback and Q&A Session |
Open Discussion |
Trainer A & B |
03:30 - 04:00 |
Closing Session |
Certificates and Feedback |
Trainer/Host |