What is Qualification in the Pharmaceutical Industry?

What is qualification in the pharmaceutical industry?

Qualification, of stability chambers to ICH guidelines is usually only required in the Pharmaceutical and Medical Devices industries and includes an IQOQPQ or IPV.

What is an IQOQPQ?

IQOQPQ stands for Installation Qualification, Operation Qualification, Performance Qualification. During installation of a stability chamber an IQOQPQ is often performed.

The IQ establishes if the chamber is as ordered, undamaged in transit and installed correctly. The OQ checks that the chamber operates correctly in a basic way, the alarms and protections work correctly. This can also include a calibration and spatial mapping.

The PQ is usually a 24-hour run to check temporal stability and can be done empty, loaded or both. Other tests such a door open test and a power failure test can also be added here

An IQOQPQ may also be performed on a climate chamber or temperature chamber if it is to be used in the pharmaceutical or medical devices industries.

Periodically during the life of a stability chamber an IPV is performed.

What is an IPV?

IPV stands for Instrument Performance Verification. An IPV proves that the chamber is accurate, stable and fit for purpose.

It included calibration, spatial variation check and usually temporal fluctuations tests which are certified using traceably certified 21 CFR Part 11 compliant standards.

Again, an IPV may be carried out on other environmental simulation chambers and laboratory test chambers if they are being used in the pharmaceutical or medical devices industries.

What is the difference between an IQOQPQ and an IPV?

An IQOQPQ is more comprehensive as it includes showing that the chamber is installed correctly and that its various functions and protections are working as expected. In addition, calibration, spatial variations and temporal fluctuations can be certified using traceably certified 21 CFR Part 11 compliant standards.

Other tests can also be included.

How can DACTEC help you?

DACTEC provides the following as part of its IQOQPQ and IPV service.

For both IQOQPQ’s and IPV’s the tests required can be tailored to your requirements:

Removing tests or adding in extra tests.
Removing or adding in set points.
Empty or loaded chamber – to test to the manufacturer’s spec during an IQOQPQ the chamber should be empty. It can also be tested loaded but to wider specs. Usually, IPVs are performed on loaded chambers.
Power failure test – this seeks to determine how long it would take for the conditions to go out of spec after power is removed. There is no manufacturer’s specification for this.
Door open test – this determines how long it takes the chamber to come back into spec after the chamber door is opened for a period such as 1 minute. There is no manufacturer’s specification for this.

Once these are agreed we produce a draft document for you to review and approve.

More Information.

You might also find the following blogs of interest:

Click on the following links to see pharmaceutical technology other than stability chambers used in the pharmaceutical and medical devices industries provided by DACTEC and Weiss Technik:

If you would like to discuss what qualification in the pharmaceutical industry means for you or how we can help you with chamber mapping and qualification for your application, please don’t hesitate to contact us, we are happy to help. Contact us.

If you would like more information about DACTEC’s service support, such as: