Fundamentals of EU GMP Annex 1
About Course
This is an essential online course designed to provide you with a comprehensive and practical understanding of the global standard for sterile medicinal product manufacturing.
The current revision of EU GMP Annex 1 represents a paradigm shift. It introduces a stronger emphasis on Quality Risk Management (QRM) and mandates the implementation of a holistic Contamination Control Strategy (CCS). Whether you are involved in production, quality assurance, or engineering, understanding these principles is essential for ensuring that every batch meets the highest standards of safety.
Key Topics Covered:
- Principles for Manufacturing of Sterile Products
- Contamination Control Strategy (CCS)
- Pharmaceutical Quality System for Manufacturing of Sterile Products
- Premises for Sterile Product Manufacturing
- Control of Material and Personnel Flow
- Isolators and RABS Technology
- Cleanrooms and Clean Air Equipment Qtaification
- Equipment, Utilities, Personnel, and Environment Requirement for Manufacturing of Sterile Products
- Sterilization Process
- Aseptic Process Simulation (APS)
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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Introduction to EU GMP Annex 1
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General Principles for Manufacturing of Sterile Products
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Contamination Control Strategy (CCS)
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Pharmaceutical Quality System for Manufacturing of Sterile Products
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Pre Assessment-1
Module II
Module III
Module IV
Module V
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Student Ratings & Reviews
good
Very useful and knowledge full content
This is an excellent course for anyone working in a pharmaceutical sterile facility.
Helpfull!