Equipment qualification and life cycle management
This module introduces various pharmaceutical industry equipment and different stages of equipment qualification such as design, installation, performance and general operations.
Introduction to equipment qualification and life cycle management including regulatory expectations.
No impact, indirect and direct impact systems
Validation master plan and the “V-model”
User specification requirements and design
Aspects of commissioning and handover
Extent of verification and documentation based on risks, product quality, patient safety, and system complexity.
Qualification steps including Factory Acceptance Test (FAT) and Site Acceptance Test (SAT), installation, performance, and operational qualification
Maintenance and decommissioning of equipment
Why it matters
Equipment used in production, especially the ones that come in direct contact with the drug product can affect product quality and patient safety. Qualification ensures that equipment is fit-for-intended use throughout its lifecycle from concept to retirement. It provides assurance that the systems that can impact product quality have been properly designed, installed, and tested according to pre-determined acceptance criteria.
Who is it for
Employees in production, engineering, quality control and quality assurance, either directly operating or maintaining equipment and utilities should complete this module.