![]() ![]() Then, we verify the extraction of the analyte from a new matrix using the validated method. First, we validate the analytical method following the requirements of ICH Q2(R1) using a common matrix. We call it the ‘Validate and Verify’ approach. When used together they make sure a product, service, or system, meets regulatory requirements and specifications as well as fulfills its intended purpose.Īt Labstat, we account for the highly variable nature of different matrices with a two stage approach to validation. It’s important to recognize that a single analytical method cannot be developed to separate an analyte of interest in every possible matrix. Similar, but not interchangeable, verification authenticates that a product is what it says it is, whereas validation confirms that a product is suitable for the intended use.īoth are critical components of a quality management system. This ensures product quality, consumer safety, and safeguards your business against costly delays.Ī certified lab will help you prepare for both method validation and verification, guiding you through the regulatory requirements and the documentation needed to capture validation activities. The use of validated methods provides a true and accurate assessment of product quality which is paramount to delivering a safe product to consumers, which ultimately safeguards your brand and your business.īased on the data collected during validation the laboratory will have a detailed understanding of how the methods’ parameters, such as mobile phase composition, gradients, temperature, flow rate, etc. Beyond simply being a requirement, proper method validation can be your business’ secret weapon. Health Canada adopted the regulatory requirements for method validation established by The International Conference on Harmonization (ICH) which were created to investigate critical activities such as stability, method validation, GMP manufacturing, and product development in the pharmaceutical industry.ĭuring validation a set of experiments are conducted, following a protocol, to assess the analytical methods ability to perform as expected/required. Since cannabis is regulated by Health Canada it is subject to Good Production Practices (GPP) for medical devices, cosmetics, dietary supplements and over-the-counter pharmaceuticals. ![]()
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