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GMP Training
EU Good Manufacturing Practice
EU Good Manufacturing Practice
Curriculum
10 Sections
40 Lessons
30 Hours
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Introduction to EU GMP & Pharmaceutical Quality System
5
1.1
Overview of the EU GMP
1.2
Pharmaceutical Quality System (PQS)
1.3
Quality Risk Management (QRM)
1.4
Product Quality Review (PQR)
1.5
Questionnaire
10 Questions
Personnel & Training Requirements
5
2.1
Key Personnel Roles
2.2
Qualified Person (QP)
2.3
Training Programs
2.4
Personnel Hygiene & Health
2.5
Questionnaire
12 Questions
Premises & Equipment
5
3.1
Premises Design & Maintenance
3.2
Storage Areas
3.3
Equipment Qualification & Maintenance
3.4
Utilities
3.5
Questionnaire
0 Questions
Documentation & Record-Keeping
4
4.1
Types of GMP Documentation
4.2
Good Documentation Practices (GDP)
4.3
Batch Documentation
4.4
Document Control
Production & Cross-Contamination Control
5
5.1
Production Operations
5.2
Cross-Contamination Prevention
5.3
Validation
5.4
Materials Handling
5.5
Questionnaire
0 Questions
Quality Control & Stability Testing
5
6.1
QC Department Responsibilities
6.2
Laboratory Controls
6.3
Stability Programs
6.4
Method Validation & Transfer
6.5
Questionnaire
0 Questions
Sterile Product Manufacturing (Annex 1)
4
7.1
Cleanroom Classifications
7.2
Aseptic Processing
7.3
Sterilization Methods
7.4
Personnel & Gowning
Biological Product Manufacturing (Annex 2)
5
8.1
Scope & Principles
8.2
Production Controls
8.3
Specific Product Types
8.4
Traceability & Biosafety
8.5
Questionnaire
0 Questions
Radiopharmaceuticals (Annex 3)
5
9.1
Specific Risks & Controls
9.2
Production & QC
9.3
Documentation & Release
9.4
Personnel & Training
9.5
Questionnaire
0 Questions
Complaints, Recalls & Self-Inspection
5
10.1
Complaint Handling
10.2
Recalls
10.3
Self-Inspection
10.4
Quality Defects & Risk Reduction
10.5
Questionnaire
10 Questions
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