Course Agenda: Quality Management System and Good Manufacturing Practice (ICH-GMP)
(Please note that the order of the topics and the course agenda may be modified based on the need of the class)
1. What is Quality Management System and what is GMP?
a. Brief history of GMP
b. Why is GMP important?
c. ICH-GMP Structure and requirements
2. Role of Quality (QA/QC)
a. Quality Assurance vs. Quality Control
b. What does Quality Ownership mean?
c. What is your role within the big picture of your company Total Quality Management System?
a. Cleaning requirements
b. Calibrate what and Why?
a. What is Validation?
b. What types of validation are required?
c. How do you perform validation?
5. Sanitation and Hygiene
a. Sanitation requirements
b. How do you prevent contamination?
c. Personal hygiene
a. What is a label?
b. What needs to be on a label?
c. What does ‘Quarantined’ mean?
7. Records and Documentation
a. What is a Record?
b. Good Documentation Practices
c. Prevent common documentation errors
a. Writing and reviewing SOPs
b. Regulatory requirements and compliance
c. How a company control these to be in compliance?
9. Deviations/Change Control
a. Why is it important to document Deviations?
b. What is Change Control?
c. What is the change control process?
10. The Manufacturing Cycle
a. Quality at every step of manufacturing
b. What are some specific GMP requirements?
c. Consequences of poor controls
11. Audits and Inspections
a. Be ready for audits and inspections
b. How to prepare for a successful audit or inspection?
c. What do Health Canada inspectors look for?
12. Group discussion and conclusion
- Teacher: Pr. Peivand Pirouzi