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GMP Trainings
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
Curriculum
6 Sections
6 Lessons
Lifetime
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Module 1
2
1.1
Scope, Principle, and Contamination Control Strategy
1.2
Questionnaire
10 Questions
Module 2
2
2.1
Premises, Cleanroom Grades, and Barrier Technologies
2.2
Questionnaire
10 Questions
Module 3
2
3.1
Equipment, Utilities, and Personnel
3.2
Questionnaire
10 Questions
Module 4
2
4.1
Production (Terminal Sterilisation, Aseptic Processing, Specific Technologies)
4.2
Questionnaire
10 Questions
Module 5
2
5.1
Environmental and Process Monitoring, Aseptic Process Simulation (APS)
5.2
Questionnaire
10 Questions
Module 6
2
6.1
Quality Control and Glossary
6.2
Questionnaire
10 Questions
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