Method Verification & Transfer

Method Verification & Transfer

GA Labs coordinates and executes method transfer projects into GA Labs's laboratory and also those that are transferred to an alternate facility. Whether your company requires complete oversight of the project, including protocol creation, testing, and report generation, or simply execution of the analytical tests in accordance with your provided protocol. GA Labs is prepared to participate at any level. Throughout the method transfer process, GA Labs will work to ensure your quality requirements are upheld.

Compendial and monograph methods do not need full validation. However, they must still undergo verification to assess selected analytical performance characteristics as per USP <1226> Verification of Compendial Procedures. This verification confirms that the method is suitable for its intended purpose.

Existing analytical methods can be transferred to GA Labs for direct testing use and optimization as per USP <1224> Transfer of Analytical Procedures. Whether your product requires comparative testing or inter-laboratory method validation, we have the resources to ensure your method transfer goes smoothly.

Types of method transfer:

• Comparative testing
• Covalidation between two laboratories or sites
• Complete or partial method validation or revalidation
• Omission of formal transfer processes, termed as ‘transfer waiver’