Becoming a Validation Engineer… Let’s look!

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A Validation Engineer is the person who plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.

If you are becoming a validation engineer in medical industry, you need to be able to measure and analyze the process, audit and calibrate equipment and create a document trail to ensure the highest quality products are produced (objective evidence).

There is currently a high demand for trained validation engineers in the industry around the world. Let’s take a closer look at the details of validation process which reduce the margin for errors, so the product quality can be maintained within industry standards or regulatory authority requirements (For more details a document is available on the Internet at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf “Guidance for Industry, Process Validation: General Principles and Practices”)

Validation Process

Process and Equipment Validation is a method to establish evidence that a product is produced that meets the predetermined specifications. When a new machine or equipment is acquired, a master validation plan is designed to test the functional specifications and other user requirements. As a part of the validation process, the area of Qualification further divides into IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

For industries involved in pharmaceutical and medical devices, IQ, OQ and PQ are an essential part of quality assurance through equipment validation. Therefore, IQ, OQ and PQ protocols are ways of establishing that the equipment which is being used or installed will offer a high degree of quality assurance, so that manufacturing processes will consistently produce products that meet quality requirements and obtain information based on facts as documentation correct, accurate and clear with the purpose of provide evidence during FDA audits and to be in compliance with quality standar.

Installation Qualification (IQ)

Installation Qualification (IQ) is a documented process that verifies that all aspects of facility, utilities and equipment that affect product quality adhere to the approved design specifications, and that the piece of equipment or instrument has been properly delivered, correctly installed and configured in accordance with the manufacturer’s specifications or installation checklist.

All equipment and machines used in the manufacturing process of medical devices require IQ. It supports manufacturers in properly establishing key areas of operation such as maintenance plans and calibration tolerances, as well as cleaning or microbiological procedures. IQ is the first step in the qualification of new equipment.

For successful qualification, the main requirements for the installation qualification are:

· Installation location and floor space (work station dimensions/ layout)

· Checking proper power, gas supply and other energy sources

· Confirming that the environmental, safety, microbiological and operating conditions are within the manufacturer’s guidelines

· Verifying software installation as required.

· Unpacking instruments and checking for damage

· Recording the calibration dates of all equipment used for IQ

· Gathering all manuals and certificates of conformity

· In general, verifying that the material is adequate to meet the clean room requirements.

Operational Qualification (OQ)

Once each protocol of the IQ phase has been met and the IQ test report is released; Operational qualification (OQ) is performed to check that the equipment’s performance is consistent with the user requirement specification, within the manufacturer-specified operating ranges. During the OQ phase, all the items in the test plan are tested individually and their performance documented. This is a prerequisite for technical acceptance of the equipment and the facility, so it can only be performed once the IQ has been successful.

Essentially, Operational Qualification is the testing of each individual component specification of the equipment.

For successful qualification, the main requirements for the operational qualification are:

· Alarm conditions and expected results

· Pressure range and control

· Vacuum controlling systems

· Display units and signaling LEDs

· Temperature controls

· Overheating and low-temperature

· Humidity measuring and controlling systems

· Fan and fan-speed controllers

· Access controllers

· Exposure time

Performance Qualification (PQ)

In the performance qualification phase, the validation engineer will challenge the equipment, much like in the OQ phase, but now under load. PQ is the final step in qualification processes for equipment, and this step involves verifying and documenting that the equipment is working reproducibly within a specified working range. Instead of testing each instrument individually, they are all tested together as part of a partial or overall process. Performance Qualifications should be approved before protocol execution.

The Performance Qualification (PQ) protocol is a crucial part of process validation and qualification, which is used to ensure ongoing product quality by documenting performance over a period of time for a certain process.

A successful PQ will confirm the process design and demonstrate that the commercial manufacturing process performed as expected.

For successful qualification, the main requirements for the performance qualification are:

· The approach to PQ should be based on the overall product and process understanding.

· The PQ lots should be manufactured under normal conditions like equipment limits, operating parameters and component inputs.

· A list of the data that should be recorded or analyzed during tests.

· A sampling plan which outlines the sampling methods used during and in between production batches.

Once you have completed these three phases, IQ, OQ and PQ, the equipment is available for use in whatever process you intended for it. Be a successful validation engineer!

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Anel Moreno

New Business Development Manager

Anel is an engineer with quality control and continuous improvement background acquired through seven years supporting industrial manufacturing via strategic procurement and production control organizations.Currently, she is now in charge of new business creating job relations with new clients to find innovative solutions to the client’s needs.