Page 15 - Quality control of pharmaceuticals (07-PA 704)

DQ is the Pre-purchase activity (‫) نشاط ما قبل الشراء‬
concerned with:
- Definition of specifications
- Lead to selection of instruments.
Not necessarily to be documented.

2. Installation Qualification (IQ)
IQ is the documented collection of activities concerned with:
Delivery of the instrument as designed and specified.
Installation in the properly selected environment.
According to U.S.P “environment should be suitable for the instrument”

3- Operational Qualification (OQ)
OQ is the documented collection of activities to demonstrate that :
The instrument meets user and manufacturer, operational specifications.
The instrument functions according to operational specifications.

Operational Qualification is concerned with testing of:
Operational controls, switches, displays and alarm points.
Parameters (functions) of the instrument (λ scale, resolution …..)
Operational qualification is repeated at:
Regular intervals
After repair