US FDA finalises analytical procedures and methods validation guidance
The guidance - entitled ‘Analytical Procedures and Methods Validation for Drugs and Biologics’ - supersedes a draft released in February 2014, setting out how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
The US Food and Drug Administration (FDA) which published the guidance yesterday, defines an analytical procedure as one developed to test a defined characteristic of the drug substance against established acceptance criteria for that characteristic, while method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose.
But such procedures must be followed during the life cycle of the product, the FDA says, to continually assure that it remains fit for its intended purpose:
“Over the life cycle of a product, new information and risk assessments (e.g., a better understanding of product CQAs or awareness of a new impurity) may warrant the development and validation of a new or alternative analytical method.
“New technologies may allow for greater understanding and/or confidence when ensuring product quality. Applicants should periodically evaluate the appropriateness of a product’s analytical methods and consider new or alternative methods.”
The agency advises drugmakers to pre-empt such life cycle changes in analytics by maintaining an appropriate number – based on scientific principles and an assessment of risk - of retention samples.
Furthermore, “if a risk-based evaluation or other drivers lead to changes in an analytical procedure or replacement with a new method,” the guidance adds, “an analytical method comparability study, or a combination of these exercises should be considered.”
The full FDA guidelines can be viewed below: