What are the phases of qualification?
The Four Stages of Equipment Qualification
- Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
What is operational qualification?
Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
What is DQ protocol?
Installation Qualification (IQ) Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill.
How many stages are there in qualification?
The four qualification stages help determine if the process being tested is capable of operating in its specific environment. They include: Qualification (DQ) Installation Qualification (IQ)
What is Cat 3 runway?
A CAT IIIB system helps with a precision approach and landing when the runway visibility is at a distance no less than 50 feet (15m) and is at a visual range less than 200 meters and most certainly not less than 50 metres. The whole process is automated.
What is OQ PQ IQ?
IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.
What is DQ in validation?
Design qualification is the primary document that confirms that design is expected to work. By the use of a design validation protocol, it is possible to determine if the item will deliver its full functionality based on the URS. It should also conform to the requirements of the Validation Master Plan.