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Validating methods

We can use JDK Modules and also we can create our own modules as shown below: Simple Module Example Here We are using ‘module’ to create a simple module.

Each module has a name, related code and other resources.

Some AMD and AMV elements were added to the ICH characteristics. For example, three spike levels may not be sufficient to evaluate accuracy and repeatability precision over the valid assay range.Before Java SE 9 versions, we are using Monolithic Jars to develop Java-Based applications.This architecture has lot of limitations and drawbacks.The rigorous standards suggested here are ideal, but they are not necessarily required or followed during method development.Methods can be developed without strict adherence to GMP regulations if adequate documentation systems are used.When developing a new method for a new biopharmaceutical product, or when changing a release method for a licensed product, many development and validation elements should be considered.Currently, these are incompletely covered by regulatory guidelines.We must be careful not to invalidate the AMD data that were used to establish robustness and system suitability criteria and which were likely used to derive some of the acceptance criteria for the AMV protocol.All ICH validation characteristics should be evaluated during AMV.All planned data sets must fall within pre-established protocol acceptance criteria (limits).These criteria should be derived from and justified in relation to historical data and product specifications.


  1. Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. Analytical methods.

  2. Validating Analytical Methods for Biopharmaceuticals, Part 1 Development and Optimization. Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps. Oct 01, 2004. By Stephan Krause, PhD. BioPharm International. Volume 17, Issue 10.

  3. CGMP. GCP. ISO 17025. PIC/S. GxP. FDA. LOD/LOQ. OECD. QA/QC. API EP. SOP. ICH Q2R1. Validation of. Analytical Methods. Validation of Analytical Methods. A Primer.

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