Certificate of Qualification (IQ/OQ)

Certificate of Qualification (IQ/OQ)

What is Certificate of Qualification (IQ/OQ)?

One of the most important things in the pharmaceutical, medical and other industries in which precision and sensitivity play an essential role is obtaining all kinds of qualification certificates and necessary approvals.

All the devices that are used in the production process of these sensitive industries such as:Laboratory ovens, shakers, test chambers, growth chambers, furnace, incubators And… they should include these certificates so that they can give sufficient guarantees to their customers about their products such as medicine and other medical, chemical and cosmetic products.

The IQ/OQ certificate includes approvals that guarantee the safety and performance of your device in accordance with the design specifications. Because the smallest problem in the existing devices of the production line affects the quality of the final product.

Validation is a part of the quality assurance process and necessary for the production of quality products. The key items in equipment validation protocols are: Installation certificate or IQ, training and operation certificate OQ and machine performance certificate or PQ.

IQ/OQ and PQ certification are methods that prove that the equipment used and installed provide a high percentage of quality and reliability. In such a way that in the production processes, products are produced that are in accordance with the validation regulations in terms of quality.

Newly purchased equipment and devices must first be approved for installation to determine whether this device has the ability to produce a desired and high-quality product or not. This certificate is created as a document to confirm the ability of the device to meet the needs of the user. In fact, the way the device works depends on its installation method. The installation certificate confirms that the tools or equipment are qualified to function based on the manufacturer’s technical specifications or the installation checklist.

 

For example, a device may need a certain space for installation to avoid impact or damage. IQ actually ensures that the environment and installation conditions meet the minimum requirements of a device. Based on FDA’s definition, competency certificate or IQ is defined as follows: The factors that are necessary and necessary for a system as prerequisites depend on the proper functioning of the device.

What does it take to do a successful IQ?

 

A successful IQ is usually measured by considering that the installation process of devices or equipment follows the manufacturer’s instructions and meets the user’s needs, and usually includes the following:

 

  • Installation location and sufficient space for the device
  • Proper packaging and proper unboxing
  • Testing all the components of the device to ensure that they are healthy
  • Ensuring the power supply of the device
  • Installing accessories
  • Documenting device serial number and hardware information
  • Review of environmental and operational conditions
  • Checking the installation and implementation of software systems and people’s access levels
  • Record the date of calibration and validation
  • Checking all connections and connections of the device

OQ certification will be applicable when all IQ protocols are met. The purpose of OQ is to match equipment performance to user expectations. In practice, it means identifying and checking the technical specifications of the equipment, which can overshadow the final quality of the products.

 

During the OQ process, all items in the certificate are tested and their performance and results are documented. Since OQ is a prerequisite for the acceptance of devices, it can be done only after the implementation of IQ. In general, OQ is a detailed inspection of the installation, operation, maintenance and support of hardware or software (if any and if applicable). It must be shown that the technical specifications of the device are exactly in accordance with the user’s wishes.

As previously explained, OQ is actually the examination of equipment and their impact on product quality and ensuring their performance, and often includes the following:

 

  • Temperature or humidity control and their changes
  • Engine system and device board
  • Safety thermostats and supporting systems
  • How to distribute temperature or humidity
  • The display and operation of the screen controls
  • Fan control and its speed
  • Temperature and humidity range

Validation or qualification of device performance. At this step, the relevant expert is required to test the device and compare the results with the user’s request. PQ actually tests the entire device instead of testing individual components. It should be noted that the quality or validity of PQ largely depends on the quality and manner of testing.The FDA criteria for a PQ protocol are summarized in two elements:

 

  1. Facilities design and qualification of equipment and facilities
  2. Device performance qualification during production process (PPQ)

The purpose of PPQ is to ensure consistent product quality by recording performance over a specific time period for specific products. and generally includes the following:

 

  • A complete list of data to be recorded or analyzed during testing, calibration and validation.
  • Tests to ensure uniform quality throughout production
  • Approval of the PQ protocol by the relevant department i.e. quality control

FG Company As one of the manufacturers of laboratory and pharmaceutical equipment, which supplies the products needed for the production of pharmaceutical companies, medical, food, cosmetic, etc. companies. To assure our customers and guarantee our production devices, all IQ certificates/ It provides OQ and necessary qualifications to take a big step in the health and quality of laboratories.

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