Start Validating chromatographic

Validating chromatographic

Risk management is an iterative process and empirical data gathered in development may alter process design.

This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well.

Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development; Final method development and trial method validation; Formal method validation and report generation; Formal data review and report issuance.

Start thinking about validation in early development stages.

Understanding the potential risks associated with the host organism, raw materials, processing materials, and product-related impurities enables the design of a validatable downstream process that can mitigate those risks (Table 1).

It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations.

The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications.

After the initial design phase, characterization (also called robustness) studies that use Design of Experiments (Do E) plus further experimental work enable the establishment of ranges in which the process always delivers the requisite active pharmaceutical ingredient (API) quality.

Conformance or validation batches confirm that the entire process can be run consecutively at least three times.

All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them.

Step 1: Method Evaluation and Further Method Development. Step 2: Final Method Development and Trial Method Validation. Step 3: Formal Method Validation and Report Generation.

Validation begins in development and includes a life-cycle approach.