The Life Sciences market is evolving at breathtaking speeds, driven by rapid product innovation and advancements in cell therapy technology, such as CAR-T therapies and stem cell engineering. This dynamic growth calls for companies to adopt robust quality and compliance strategies to meet regulations and produce safe, reliable products.
Globally recognized Good Manufacturing Practice (GMP) regulators, such as those in the United States, European Union, and other jurisdictions, are sharpening their focus on quality and compliance practices. For example, the FDA’s recent updates to 21 CFR Part 11 emphasize stricter controls on electronic records and signatures to enhance data integrity, and the new USP chapter 1079.4 provides the latest guidance to ensure storage areas meet strict compliance standards while protecting patient outcomes. A significant trend in regulatory thinking is the shift from quality-by-test to quality-by-design systems and processes, with an emphasis on the level of risk to product quality and patient safety.
Increased regulatory scrutiny in the Healthcare and Life Sciences (HLS) industry has heightened the need for compliance across all aspects of business operations, including development, design, equipment operation, processes, test methods, standard operating procedures, computerized systems, and data security. To navigate this ever-changing landscape, organizations require knowledge and leadership that can grow with industry demands.
Among the critical topics in this space are validation, calibration, and qualification—terms that are foundational to ensuring quality and compliance. Understanding their differences is essential for adhering to GMP guidelines. I’m often asked:
- “What is the difference between calibration and validation? Are they the same? Is one a subset of the other?”
- “I’m struggling to separate the two. Can you provide definitions and explain how they differ?”
Breaking Down the Basics: Calibration vs. Validation
At the most basic level:
- Calibration ensures that an instrument’s measurements are accurate by comparing its output to a reference standard and correcting any deviation.
- Validation involves testing and documenting a process, procedure, or activity to ensure consistent results within predefined criteria.
Many in the Healthcare and Life Sciences industry know these terms, but not everyone fully understands their distinctions. Here’s a closer look:
What is Validation?
Validation is the documented act of demonstrating that a procedure, process, or activity will consistently produce results meeting predetermined acceptance criteria. In the pharmaceutical and biotech industries, validation frameworks often include protocols such as:
- Installation Qualification (IQ): Verifying that equipment is installed correctly.
- Operational Qualification (OQ): Confirming that equipment operates as intended.
- Performance Qualification (PQ): Ensuring that equipment consistently performs under real-world conditions.
Other critical components include the User Requirement Specification (URS) and the Validation Master Plan (VMP).
Why is validation essential? Simply put, “If it’s not written down, it didn’t happen!” The FDA requires documented evidence to demonstrate that a specific process will consistently produce results meeting specifications and quality attributes. Without such documentation, companies risk non-compliance.
What is Calibration?
Calibration focuses on measurement devices, instruments, and tools used to record, monitor, and control environmental conditions or parameters. For example, thermometers, freeze indicators, temperature recorders, dataloggers, and equipment monitoring devices used in cold storage facilities, as well as pressure indicators and weight load cells in pharmaceutical manufacturing, often require regular calibration to ensure accuracy. It is the process of ensuring that an instrument produces results within specified limits when compared to a traceable standard. Calibration also involves adjusting the instrument to realign it with the acceptable standard if necessary.
Taking measurements in any GxP (Good Practice) process requires calibrated instruments to ensure accuracy. For example:
- Instruments that record and monitor critical environmental variables must be calibrated regularly.
- GMPs mandate written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
Key Differences Between Validation and Calibration
| Validation | Calibration |
| Validation is the documented act of demonstrating that a procedure, process, or activity will consistently produce results meeting predetermined acceptance criteria. | Calibration ensures accuracy is maintained in measurements produced by instruments or equipment. |
No reference standards are used in validation. | Calibration performance is always compared against a reference standard. |
| Validation provides proof of consistency across all processes, demonstrates that equipment is fit for use, and confirms the suitability of batches of products and methods used. | Calibration ensures the accuracy of measurements. |
| Validation is performed when new equipment or systems are installed, modifications are made to existing systems, or the validation period has expired. | Instruments must be calibrated regularly. Drift in measurements should be identified and corrected through calibration (realignment). |
| Performed as per validation protocols (IQ, OQ, PQ). | Performed as per calibration Standard Operating Procedures (SOP). |
Why It Matters
Understanding these basic concepts is essential for improving operational efficiency, maintaining regulatory compliance, and ensuring the reliability of processes in the Life Sciences industry. While the processes may seem long and drawn-out, they serve a critical purpose: ensuring that products perform consistently, meet industry requirements, and protect patient safety.
By recognizing the importance of validation and calibration, professionals can appreciate the value they bring to the industry. These practices not only enhance the reliability and quality of products but also underscore the significance of our work in ensuring compliance and consistency. Ultimately, this leads to saving lives by producing safe and effective healthcare solutions.
Conclusion
Validation and calibration are cornerstones of quality assurance in the Life Sciences industry, ensuring patient safety through reliable processes and enhancing product reliability to meet stringent regulatory standards. Whether ensuring that instruments provide accurate measurements or that processes consistently meet regulatory standards, these practices play a vital role in delivering safe, reliable products. Understanding their differences and applications is critical for meeting GMP guidelines and maintaining compliance in this ever-evolving industry.
Nathan Roman is a distinguished professional with over two decades of experience in Health & Life Sciences, specializing in commissioning, qualification, and validation. With a keen focus on temperature mapping, Nathan’s expertise ensures compliance solutions and product integrity. As a seasoned US Director of Marketing and Global Brand Ambassador at Ellab, he seamlessly blends traditional validation knowledge with contemporary marketing strategies. Nathan’s contributions extend to significant advancements in equipment qualification, temperature mapping, and co-authoring the ISPE Good Practice Guide for Controlled Temperature Chambers. His commitment to the industry is further showcased in his book ‘Six Steps to Effective Temperature Mapping’. Connect with Nathan to explore collaborative opportunities and discover innovative practices driving Health & Life Sciences excellence. (Connect on LinkedIn)
