Course Certificate

GAMP 5 Introduction

Good Automated Manufacturing Practice (GAMP) provides the opportunity to follow a logical and systematic approach to categorization, documentation, and risk assessment of automated systems.

During the course, the participant has acquired knowledge of:

• Relevant GMP rules and guidelines for the development and verification of automation systems.
• Where inspiration and guidance can be found for creating relevant documents, and which phases to go through in planning, development, and testing of the systems.
• The issues at different life cycle stages and at different levels of complexity.
• How risk is managed in relation to patient safety, product quality and data integrity.
• How specification and verification material can be scaled according to risk.
• How you, as a pharmaceutical manufacturer, can involve the subcontractor in the overall validation activities and thus avoid unnecessary duplication of work.
• How you as a subcontractor live up to pharmaceutical manufacturers' expectations of good practice with subcontractors.
• How software categorization can reduce the required documentation and validation activities.

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