Validation and qualification
White paper: Validation and qualification in a regulated environment
This whitepaper explains how validation and qualification are classified in the scope of the GMP guideline and how the process is shaped with a focus on unit qualification.
The qualification of equipment in the pharmaceutical industry is a significant part of quality assurance and is required by law.
The whitepaper provides an overview of how validation and qualification are classified in a GMP environment (Good Laboratory Practice), and describes the general approach for qualification with the key steps of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The focus is on unit qualification. The validation of computer-based systems is also discussed briefly.
This free white paper contains information on:
- Good Manufacturing Practice (GMP)
- Process and approach in the context of validation and qualification
- Validation of computer-based systems