Pharmaceutical Microbiology

Wednesday 8 June 2022

Analytical method development (ICH Q14)

New guideline in draft for review - ICH guideline Q14 on analytical procedure development

The guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach.

The update includes reference to an enhanced approach for analytical method development:

The enhanced approach offers a systematic way of developing and refining knowledge of an analytical procedure. An enhanced approach should include one or more of the following elements in addition to those already described for the minimal approach:

An evaluation of the sample properties and the expected variability of the sample based onmanufacturing process understanding.
Defining the analytical target profile (ATP)
Conducting risk assessment and evaluating prior knowledge to identify the analytica lprocedure parameters that can impact performance of the procedure
Conducting uni- or multi-variate experiments to explore ranges and interactions between identified analytical procedure parameters.
Defining an analytical procedure control strategy based on enhanced procedure understanding including appropriate set-points and/or ranges for relevant analytical procedure parameters ensuring adherence to performance criteria.
Defining a lifecycle change management plan with clear definitions and reporting categoriesof established conditions (ECs), proven acceptable ranges (PARs) or method operationaldesign regions (MODRs) as appropriate.