What is Installation Qualification? When installation qualification is done?
Definition of Installation qualification: Installation qualification IQ is a part of the validation process of equipment, system or the manufacturing area where the equipment is verified for its compliance with respect to its design, operation and correctness after the equipment system or the area is installed or commissioned. To do this the documentary evidence is generated for satisfactory compliance with equipment URS and Design qualification.
How to do installation qualification (IQ):
The equipment after satisfactory compliance of site acceptance test is required to be subjected for factory acceptance test. Where a set of parameters are verified for suitability of equipment at the factory.
The equipment is installed as per the design and drawing of the area, electric connections are provided, and operating panels are verified for its operation.
A set of tests are defined for equipment, system, or the area itself for qualifying the installation so that the purpose of the equipment is fulfilled, and the objective of the equipment is fulfilled.
Example of the IQ of the Water system.
After the installation of the water system following points which are major here are taken as an example for explaining the installation qualification of equipment in general are described.
Following things are verified as per the set of documents provided by manufacture and the URS of the pharmaceutical company.
1. Material of construction: 316 L
2. Certification of electro polished inner surface of the distribution and loop piping.
3. Seamless polished wielding.
4. Bend degree.
5. Volume of water retained in the pipe.
6. Slope of the line.
7. Functioning of the valves and loop.
8. Motor specifications, made as per URS.
9. Capacity like 5000 liters / hour.
10. Vent filter quality and grade and certification for porosity less than 02 microns.
11. Calibration of inline, water velocity meters, pressure gauss.
12. Backup in case of electrical failure.
13. Online PH and conductivity meter calibration and certificates.
14. Distribution points.
15. Sampling points.
16. Dosing system for chlorine and sodium metabisulphite.
17. Certificate of Ion exchange resin, its Chemical composition and safety data.
18. Calibration of temperature measurement gauze.
19. Water sprinklers flow. Spray ball is able to cover all areas inside the tank.
20. Glass view window for storage and distribution tank.
21. RO Membrane certificate of quality.
Etc. These points are also covered in the URS; these are checked after installation, and verified that the installation is perfect and supports the operation.
The installation is the responsibility of the manufacturer of the equipment, therefore the document for the purpose of installation is submitted by the manufacturer to QA of the pharma manufacturing unit, and after review additions and deletions the document is issued by QA dept. for conducting the installation qualification.
The report is filled and in the final page a certificate is issued to the company by the manufacturer on the qualification of installation.
If any untoward incidence or deviation occur, it should be recorded as per the SOP for handling the deviation. If any change is to be done it should be done through change control system, change management system.
Finally, after installation a training is provided to the pharmaceutical manufacturer and its staff for the operation, maintenance, and cleaning of the equipment installed.
Requalification: Invent of any changes are done in any equipment or the system, requalification of Installation is required to be done.