Analytical Method Transfer
Ensuring analytical methods are fully validated, seamlessly transferred, and verified for routine testing.
Analytical Method Transfer and Verification
A method must be suitable for the receiving laboratory, product, specification, equipment, software, and intended use before routine testing begins. Globyz Clinical Solutions uses a documented review and transfer pathway to identify gaps, agree responsibilities, execute an approved protocol, evaluate acceptance criteria, and confirm routine readiness.
Submit a Method for Review
Method Suitability
Proven accuracy & reproducibility
Information Required
To ensure a seamless method transfer, please provide the following technical details and documentation.
Analytical Method
Current approved analytical method and specification document.
Prior Reports
Method development, validation, verification, or prior transfer reports.
Chromatograms
Representative chromatograms, calculations, and known method sensitivities.
Product Matrix
Product, placebo, and matrix information where relevant.
Reference Standards
Reference standards, impurity standards, columns, reagents, and special materials.
Logistics
Sample quantity, storage, handling, safety information, and target timeline.
Transfer Pathway
1. Gap Assessment
Compare the method with equipment, detector, software, materials, environment, sample preparation, and analyst capability.
2. Protocol
Define samples, preparations, runs, parameters, acceptance criteria, deviations, responsibilities, and reporting.
3. Execution
Perform approved activities using controlled records and communicate material observations promptly.
4. Evaluation
Review data, system suitability, acceptance criteria, deviations, and investigations before conclusion.
5. Routine Readiness
Approve the method for its intended use only after transfer or verification requirements are met.
Compendial Method Verification
Compendial status does not remove the need to demonstrate suitability under actual laboratory, equipment, product, and matrix conditions. The verification scope is selected according to the method, compendial expectations, intended use, and risk.
What You Receive
The agreed package may include a gap assessment, approved protocol, raw and processed data, deviations or investigations, technical review, final report, and routine testing readiness decision.
Accelerate Your Analytical Testing
Get in touch with our experts to discuss your pharmaceutical analytical testing needs and ensure absolute compliance and quality.