Method Validation

Validates analytical and microbiological testing methods to meet regulatory standards.

Ensures the reliability and accuracy of methods used in quality control.

Tailors method validation to client-specific products and regulatory requirements.

Documents the entire validation process for audit and compliance purposes.

Conducts performance qualification (PQ) to ensure methods are fit for purpose.

Monitors and assesses the repeatability and reproducibility of validated methods.

Assures consistent and reliable results across multiple test runs and operators.

Follows ICH (International Council for Harmonisation) guidelines for method validation.

Incorporates ongoing method refinement and revalidation as needed.

Provides validation reports to support regulatory filings and submissions.