Why Should You Attend:
Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.
Agenda
- Basics of commissioning and Installation Qualification
This session defines commissioning and Installation Qualification (IQ), summarizes their purposes, and identifies differences between them. It outlines the progression of commissioning and IQ in a validation project, along with the roles of Factory Acceptance Testing and Site Acceptance Testing. It describes how responsibilities for commissioning and IQ are assigned in a typical company. It identifies vendor equipment documentation that may be included in specifications, as well as the contents of commissioning reports.
This session explains the roles of impact assessment and criticality assessment. It discusses how to draw system boundaries and use impact assessment to determine the scope of qualification work required.
This session describes how to decide which components of each system require qualification and which need only be commissioned. It identifies systems/services that support the production line, and gives examples of tests applied to them as part of qualification. It identifies important parts of IQ protocols, and gives examples of qualification criteria specified in protocol test sheets. Finally, it outlines requirements for calibration of devices, instruments and systems.
