Qualifications

Part 10 The qualification sequence is: URS → Risk Assessment → DQ → FAT → SAT → IQ → OQ […]

Part 9 The required lifecycle sequence is: URS → Risk Assessment → DQ → FAT → SAT → IQ →

Part 8 The lifecycle position is: URS → Risk Assessment → DQ → FAT → Shipment → Installation → SAT

Part 7 The FAT should fit the overall evidence chain established in the handbook: Intended Use → URS → Risk

Part 6 6.1 What Is Design Qualification? Design Qualification (DQ) is the documented verification that the proposed design of a

Part 5 The central principle is: Risk assessment should determine what needs to be tested, why it needs testing, how

Part 4 4.1 Introduction Not every facility, utility, equipment item, instrument, or computerized function in a pharmaceutical plant presents the

Part 3 3.1 Introduction The User Requirement Specification (URS) is one of the most important documents in pharmaceutical qualification. Every

Part 2 A critical principle applies throughout: Not every document listed below is universally mandated by regulation as a separately

Part 1 1. Introduction Qualification is one of the fundamental elements of pharmaceutical Good Manufacturing Practice (GMP). A pharmaceutical manufacturer