The analytical instrumentation space is a key part of the pharmaceutical manufacturing industry. Raman spectroscopy is becoming one of the increasingly popular PAT tools among the analytical instrumentation that have been deployed recently. To maintain compliance, equipment reliability and durability are essential. Investing in a quality assurance system is indispensable.

If you work in the pharmaceutical or medical device industry, you are almost certainly aware of the terms IQ, OQ, and PQ. Having a dependable Raman analyzer is critical as each of the three components represents a way to help ensure reliable product performance and maintain compliance.

IQ – Installation Qualification

Newly installed or modified equipment must first be qualified to verify and determine if it is capable of producing the desired results. Installation Qualification (IQ) is the first step in the qualification of new equipment. It is a documented process which verifies that all parts and pieces have been received and that an instrument has been installed and configured according to the manufacturer’s specifications or installation checklist. All aspects of the facility, utilities and equipment that affect product quality must adhere to approved design specifications. More importantly, they help substantiate and ascertain that the instrument is:

  • Correctly delivered
  • Properly placed in an appropriate environment
  • Configured according to standards set by the manufacturer

To make the IQ consequential, it is critical that it include the oversight and verification of each physical aspect of the equipment (materials, dimensions, specs, etc.), software (accessibility, speed, etc.) and instruments (operational parameters, voltage, etc.) as a routine part of the quality assurance process.

OQ – Operational Qualification

Operational qualification (OQ) is the next step in the qualification process and involves testing each of the individual components/features/physical specifications of the equipment. The primary purpose of the OQ is to determine that equipment performance is consistent with the user requirement specification. Because this a prerequisite for acceptance of equipment in the facility, OQ can only be conducted after a successful IQ. It is imperative that the test protocol for the OQ reflects the necessary functionality for instrument suitability.

PQ – Performance Qualification

Performance Qualification (PQ) is the last step in equipment qualification and a vital part of what regulated laboratories and process monitoring departments employ to maintain compliance. PQ comprises verifying and documenting the performance of the equipment. This stage is hugely important to assess whether or not the equipment is functioning productively within the desired working range. By doing so, adequate performance can be established that provides evidence that the instrument is fit for the purpose for which the equipment has been deployed.

Once you have completed these three stages, the equipment is available for use in whatever process you intended for it.

Qualification Processes – Effectiveness

Whatever tests a process monitoring department decides to do in order to qualify and calibrate a Raman system, it will need to defend the work and the suitability of the instrument during regulatory audits and inspections. Validation execution lies with the manufacturer and is a global exercise in establishing documented evidence that illustrates that a high degree of assurance that the organization will consistently produce a product of superior quality.

Sometimes, Tornado Spectral Systems receives inquiries asking if a spectrometer can be designed for a specific application. Customizations may be required, and we are happy to discuss this for each customer need. Our applications team within our Customer Success Group is available to assist with this. Subsequent adaptation of the qualification process (the IQ, OQ, and PQ steps) to the customization are critical and part of this process. Tornado has supported numerous customers globally even with customized installations. The way we adapt the IQ, OQ, and PQ processes and their impact on quality control is crucial for proper product testing and/or monitoring, which in turn leads to a well-controlled manufacturing process.

Summary

A successful IQ, OQ, and PQ is critical to verifying and documenting instrument suitability. Creating meaningful documents that achieve this purpose and provide maximum value to the customer is our goal. It is not a matter of just doing this to check a need-to-have box, though that is of practical importance also. But beyond this, we want to give the customer maximum assurance that what they have purchased and deployed is operating at the level they expect from a high-performance piece of equipment such as the Tornado Hyperflux™ PRO Plus. Customers rightfully expect much from our equipment and the IQOQPQ is a strong start toward assuring them that their expectations will be met.

For more best practices or to learn more about building an effective qualification program, please contact us at support@tornado-spectral.com

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