We use a cGMP approach to method validation to ensure that our products meet the highest regulatory standards
Method validation is a critical step of our quality management system to demonstrate the repeatability of the process and to ensure that our products always meet the highest regulatory standards following the current Good Manufacturing Practices (GMP) guidelines.
Method validation establishes the reliability, accuracy, and precision of process and analytical methods used for pharmaceuticals, nutraceuticals, and food products.
Our team of experts uses state-of-the-art equipment and advanced analytical techniques to generate high-quality data, ensuring that our products meet the highest regulatory standards. In addition, we conduct validation studies on all analytical methods used to test our products, ensuring that they are accurate, reliable, and consistent.
We also use a risk-based approach to process validation, focusing on the critical quality attributes of each parameter to ensure that our approach is appropriate and effective. Our validation includes thoroughly evaluating the method's performance characteristics, including accuracy, precision, specificity, linearity, range, and robustness.
Our commitment to method validation and GMP guidelines ensures that our products are of the highest quality and meet the highest regulatory standards. Contact us to learn more about our comprehensive approach to method validation and how we can help you achieve your product goals.