Method Development & Method Validation

What Are Method Development and Method Validation?

Method development is the process of chemistry manufacturing and controls (CMC) which involves creating and refining analytical procedures or methods tailored to specific analytical requirements. These methods are designed to identify, quantify, or characterize compounds within a sample accurately. This intricate process involves carefully selecting the most suitable techniques, instruments, and conditions to yield dependable and precise results.

Method validation entails subjecting the developed analytical method to rigorous testing and verification. Its primary objective is to ensure the accuracy, precision, and robustness of the method. Method validation confirms that the method consistently generates reliable and reproducible results within predefined limits. This validation is importance in various industries, including pharmaceuticals, chemistry, and food testing, as it is essential for regulatory compliance and maintaining the quality and safety of products.

Services at Protheragen-ING

1. Identification: Our first step involves a clear definition of the parameters to be measured, the acceptance criteria, and the intended use of the methods. This phase encompasses establishing the definition of a compliant product and selecting the appropriate analytical techniques. For instance, when addressing impurity content in small-molecule pharmaceuticals, we employ High-Performance Liquid Chromatography (HPLC) for analysis.

2. Method Development: In this phase, we begin by referring to relevant industry guidelines and regulatory provisions to determine if there are established methods applicable to the target substances of similar nature. Subsequently, we identify reference standards, select suitable instrumentation, and conduct experiments.

3. Optimization and Validation of Methods: Following method establishment, we proceed to optimize the methods and ascertain their sensitivity and stability. (For example, in substances detected using HPLC, considerations include chromatographic column selection, detector type, mobile phase composition, gradients, and more.)

4. Method Validation: We validate the methods by analysing a variety of samples to assess precision, accuracy, and specificity. This validation process involves the practical analysis of multiple sample types to evaluate the method's precision, accuracy, and specificity.

Our services are underpinned by a wide array of advanced analytical instruments. Currently, our primary techniques encompass:

Gas Chromatograph (GC): This instrument is employed to determine the content of residual solvents in products.

Mass spectrometry (MS): It is used to identify and quantify organic compounds within products with a high degree of accuracy.

Inductively Coupled Plasma Mass Spectrometry (ICP-MS): Applied to measure the elemental impurity content in products with precision.

Our state-of-the-art instrumentation, coupled with our experienced team, ensures the successful development and validation of analytical methods tailored to your unique needs and requirements.

At Protheragen-ING, we focus on precision, reliability, and excellence in all stages of our services. If you have any further inquiries or require additional information, please contact us.