Method Development, Validation, & Verification

Method Development, Verification, Validation, Modification, and Transfer are all interrelated and may occur during various phases of product development.

Method Development creates a reproducible process for preparing and analyzing a sample for a desired analytical result. Typically, method development requires a series of experiments to identify an accurate, reproducible, and efficient process for the preparation and subsequent analysis of a sample.

Scientech has the knowledge and experience to develop methods for new chemical enitites (NCEs) or other ingredients where existing published or compendial methods do not exist. Specifically, methods establish the physical characteristics of a product or ingredient(s), including its purity and potency.

Learn More

Precise, consistent, robust, stability-indicating and cost-effective analytical methods are vital to the overall product development and release timelines.

The International Conference on Harmonization (ICH) states the most common types of analytical procedures for Method Development are identification tests.

Quantitively testing the active moiety in samples of API, drug product, or other selected component(s)
Quantitively testing for impurity content
Limiting tests for the control of impurities

Method Validation is the process of proving that the Analytical Method and procedures developed for the analysis meet certain performance criteria. Precision, accuracy, linearity, range, and system suitability are some of the parameters required for method validation. Method Validation is required by regulatory agencies for data to be compliant with cGMP requirements

Method Verification is a slightly abbreviated process employed when established methods are used from compendial sources such as the United States Pharmacopeia (USP)

Key Parameters of Method Validation Include:

Specificity by ID
Linearity / Response Factor
Limit of Detection and Quantitation
Accuracy
Precision
Robustness
Solution Stability

Method transfer ensures that a method developed in one laboratory and transferred to another laboratory is suitable. The transfer of a test method and procedures is a required GMP process that qualifies a receiving laboratory to utilize a method that was originally developed by another laboratory. This process is intended to ensure and document that the method performs as intended within the variables of the receiving laboratories environment. Examples of such variables are different brands of equipment, different suppliers of chemicals and reagents, and different manufacturers of columns.