The Life Sciences market is evolving at breathtaking speeds these days, and the rapid rise in product innovation and cell therapy technology across the life science market is calling for companies to have a more robust quality and compliance approach in order to meet regulation and produce safe and reliable products.
Good manufacturing practice (GMP) regulators in the United States the European Union and other internationally recognized GMP regulators have sharpened their focus on quality and compliance practices. Driving this trend is a shift in regulatory thinking from quality-by-test to quality-by-design systems/processes with emphasis on the level of risk to product quality and patient safety.
There’s an increased emphasis by regulators in the Healthcare and Life Sciences (HLS) industry to comply with rules and regulations across all aspects of their business, such as development, design, equipment operation, processes, test methods, standard operating procedures, computerized systems, and data security amongst other things. Realizing there is an urgency for growth, leadership, and knowledge that can serve and grow with our ever-changing industry, I wanted to share some basic insights from within my profession that seem to come up more often as people enter the regulated space of the Life Sciences industry. Validation, calibration, and qualification are extremely critical in Healthcare and Life Sciences processes. Understanding them is necessary in order to meet GMP guidelines.
I’m often asked; “What is the difference between calibration vs. validation – are they the same? Is one a subset of the other?”
“I am still struggling to separate the two from each other – Can you provide me with a definition of Calibration vs. Validation and how the two differ.”
At the most basic level, calibration indicates the error of an instrument and measurers for any lack of trueness by comparison against a reference standard and validation stands for a process of testing and documenting.
Many people in the Healthcare and Life Sciences industry know the terms, but not everyone is aware of the differences.
Just a little insight will help you understand the differences between them.
Validation is the documented act of demonstrating that a procedure, process, and activity will consistently produce results meeting predetermined acceptance criteria. Pharma & Biotech’s most common way of establishing evidence or documenting test results is through the implementation of Protocols. Protocols, such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), along with essential design and planning documents such as User Requirement Specification (URS) and Validation Master Plan (VMP) are the building blocks of the validation framework.
Why is this essential? ‘If it’s not written down, then it didn’t happen!’
The FDA requires establishing documented evidence that a specific process will consistently produce results meeting specifications and quality attributes. Without supporting documentation, one runs the risk of being out of compliance.
Calibration on the other hand specifically refers to measurement devices, instruments and tools that record, monitor, and control environmental conditions or parameters. Calibration can also be defined as a process that demonstrates a particular instrument or device to produce results within specified limits with reference to a traceable standard over a range of parameters. This process also includes the adjustment of an instrument to realign with the acceptable standard.
Taking measurements involving any GxP process requires calibration to ensure the accuracy of the measurement. Instruments that record, monitor, control critical environmental variables require calibration. Instrument calibration must be enforced on a regular basis to ensure reproducible results. GMPs require written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
Understanding these generally basic concepts are an integral step to understanding quality assurance and the many different aspects of compliance in the Life Sciences industry. It all might seem like a long, drawn-out process, but there’s a good reason for it. If you can ensure your products perform consistently and meet all the requirements of the industry, the value of both the product and patient safety increases. Along with this increased value comes a greater need to understand that the work we do matters, and that helping Life Science organizations ensure compliance and consistency with current regulations when carrying out commissioning, validation and qualification projects in a safe and efficient manner ultimately leads to saving lives.