When is installation Qualification required?

installation QualificationAccuracy and high precision in instruments that are used in pharmaceutical companies, health care industries and small laboratories is critical. This is mainly because the data obtained is what is used as a guideline in getting the correct diagnosis.

What do DQ, IQ, OQ and PQ refer to in equipments?

Prior to acquiring a new equipment or instrument, you need to establish its design qualification (DQ), which is what defines that equipment. When you have established the desired specs of the equipment, which is your user requirement specification, you then go ahead and order for it. When delivery of your equipment is done, you will then develop your installation qualification (IQ) and operational qualification (OQ) basing it on the provided manual.

While evaluating IQ, you want to ensure your equipment has the specifications you stated. For OQ, you want to challenge the parameters of the equipment to see if the operational requirements are being achieved or are running the way they are supposed to. The performance qualification (PQ) phase is somewhat similar to the OQ phase, but in this phase, the equipment is challenged under a load.

If it passes this final test, you can proceed to use it for whatever process you intended it for. DQ IQ OQ PQ processes are all vital steps in process validation towards equipment qualification.

Why is IQ required?

Execution of IQ is required to verify that the equipment installation has been done in accordance with the given specifications. It also goes to show that the set CGMP (current good manufacturing practices) applicable to that installation has been observed. IQ gives the user a peace of mind by providing sufficient information about the equipment. Documentation of the entire process must be done and the records maintained.

When is IQ performed?

Installation qualification tests are carried out by a certified and qualified engineer who comes at your facility. These tests are required to be performed at various times such as:

When new equipment is installed.

  • When the equipment is moved to a new site.
  • When a computer’s software gets upgraded.
  • How to carry out Installation Qualification

Installation qualification is carried out by following a set protocol. Usually these protocols are contained in a checklist which is in accordance with existing FDA Validation guidelines. IQ is a step by step procedure that involves verification of set standards required for the quality assurance of the equipment.

It involves:

  • Verification of the installation location so that it meets set GMP (good manufacturing practices).
  • Unpacking of the instrument and cross-checking its contents with those on the packing list.

Importance of Installation Qualification

Every health care industry, pharmaceutical company and even the small laboratories have different IQ OQ PQ protocols for the various devices that they use. The tests carried out in IQ verify that the equipment being qualified has been installed properly. They also verify that such equipment satisfies all set requirements.

Summing up on Equipment Qualification and Validation Processes:

An instrument that has been in use for some time will require a requalification to verify that it is still working well. Calibration and validation is evidence that the equipment is working accurately with reference to known equipment.

Equipment validation and qualification is a comprehensive way that establishes by documentation that the equipment is accurate and working as intended. Fortunately, equipment validation services are widely available for those who either don’t have time or don’t know how to go about it.

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