pharmaceutical manufacturing, instrument qualificationInstrument qualification is a required process by many national and international pharmaceutical industry regulations and quality standards to ensure data validity and ultimately, a quality consumer product.


However, throughout our many years of working in the pharmaceutical and medical device industries, we’ve found that there is a great variation in the way companies approach their qualification processes and the way they interpret the sometimes vague regulatory requirements. Additionally, there are teams that don’t always understand that each piece of equipment undergoing qualification must meet target ranges that conform to product end destination requirements.


As a firm very much committed to helping companies achieve and maintain Food and Drug Administration (FDA), Good Pharmaceutical Practices (GxP) and Good Manufacturing Practices (GMP) compliance, we employ a holistic approach that simplifies the qualification process.


What does this mean? It means incorporating processes and tools that can save organizations time and money. It means understanding the impact that qualification has on the entire system vs. just the affected piece of equipment. It also means understanding compliance standards – both national and international – that are required for the product end use.


As part of our holistic approach, we always recommend that vendors and pharmaceutical companies do the following:


  • Establish the process for identifying the equipment/instrument and defining the intended use and minimum requirements that the system must possess or support for its intended use. This includes vendor specifications, user and functional requirements specifications, design specifications, configuration specifications and validation/qualification plan.


  • Evaluate and qualify IT infrastructure before new equipment is connected. Most, if not all, manufacturing practices are technologically controlled, which means that the infrastructure (workstation) specific to the equipment should also undergo review prior to equipment connection to ensure performance accuracy.


  • Complete a traceability matrix as part of the qualification summary report. The traceability matrix is a tool that ensures the installed system meets all of the defined design, configuration, functional and user requirements. In addition, it outlines that all of those requirements are tested/verified (as well as where) in accompanying testing documentation. If the system cannot meet one or more of the requirements, and procedural controls have been established, then the matrix will identify the appropriate SOPs where the requirements are addressed.


  • Follow prescribed equipment recertification requirements. Depending on the complexity of the equipment, and the reason for recertification, this process should be completed at least once every six months.


As we’ve discussed, a holistic approach to instrument qualification is both cost- and time-effective, and is highly recommended and critical for reliable data reporting – something that all pharmaceutical companies should strive to achieve.


Want to know more about how we can help you address your instrument qualification challenges? Contact Mike McNees at (443) 822-2479 for more information.



Interview with Syndicus GLP lead


Huber, Ludwig, “Analytical Instrument Qualification and System Validation”

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