Page 14 - Quality control of pharmaceuticals (07-PA 704)

To ensure that validation of procedure and qualification of instruments are
still maintained

How?
Evaluate the parameters using control samples (standard solutions),the
response should be within acceptable limits.
SST + procedure validation + instrument qualification
Ensure accurate & precise results

Qualification of Analytical Instruments
Qualification of analytical instruments is:
To ensure that the instruments is suitable for intended use.
To ensure validity of test results obtained from instruments.
Basic requirements for GMP

Qualification Life Cycle
Qualification Life Cycle is known as the 4 Q. model.
It involves: 1. Design qualification (DQ)

2. Installation qualification (IQ)
3. Operational qualification (OQ)
4. Performance qualification (PQ)

Design Qualification (DQ)