Monday, 11 March 2013

What is IQ OQ PQ DQ?

Brief Information about what is IQ OQ PQ And DQ

IQ OQ PQ DQ is for Qualification and validation on an Equipment , Instrument or an Process. Qualification are quality assurance standards. This type of qualification falls under the category of validation and verification. IQ is for Installation Qualification, OQ for Operational Qualification, PQ for Performance Qualification and DQ for Design Qualification or Document Qualification. It is one of the primary requirement in order to get approval form FDA, GMP/GLP , European Pharmcopoeia , ISO standards or any other Regulatory Bodies.

Design Qualification (DQ)

First type of qualification is Design Qualification. Now as per the requirement of any pharmaceutical industry or any laboratory. The specification of an equipment is planned. After making a list of specification it is send to vendor and vendor assessment is done. Vendor or supplier or manufacturer of and instrument or an equipment  is selected based on our specification. Once approving vendor , designing of an equipment is done at the vendor's site. The design should meet according to our specification.

Installation Qualification (IQ)

IQ refers to an Installation Qualification, This is the second step in qualification of an equipment. During installation qualification the components or parts of and equipment is checked and verified. Tubing , syringe, fitting and valve are checked during this step. All parts, switches or lights are checked whether working or not as per specification. All the accessories along with the equipment are checked. The environment of the equipment during installation should be as per specified in design qualification.

Operational Qualification (OQ)  

Operational Qualification is done after installation qualification. It is carried out by manufacturer or any supplier. Generally Supplier offers free service of operational qualification. Whether system is working properly or not is checked here. Various tests are performed such as Checking wavelength of detector, Signal to Noise ratio, Drift ratio, Column Temperature accuracy and precision, Injection precision, response linearity etc in case of HPLC. Similar type of tests are performed in different equipment such as GC, UV etc.

Performance Qualification (PQ)

Performance qualification is performed at regular interval to check whether it is performing well or not. PQ make sure that it is performing the task for which it was purchased at the required throughput.

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