As pharmaceutical companies change their business models, a new approach to analytical method transfer (AMT) is needed to efficiently handle transfers of multiple products, associated with situations such as site consolidations/closures, and outsourcing analysis. Analytical methods are a major tool used in pharmaceutical development to control the quality and integrity of the active drug substance or drug product.
Methods are normally developed at one site and then transferred to one or more sites during the drug development process. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another. When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
This two-day program addresses fundamental principles of method transfer, examines different strategies, and discusses key factors that will influence the transfer of analytical methods from one site to another. The focus of this training is to clarifying the essential elements that represent a complete and compliant analytical method transfer (AMT). This two-day intensive program will address the following:
- Validation of Analytical Procedures According to ICH Q2(R1) Guidelines
- Types of Method Transfer and Testing
- Essential Elements of AMT
- Method Transfer Protocols Contents, Acceptance Criteria and Approvals
- Quality Systems Required for Method Transfer
- SOPs on Technology Transfer and Method Validation
- Strategies for Successful Methods Transfer to Third Parties
- Potential AMT Pitfalls Addressing Common Failures during Method Transfer
- Quality by Design A Lifecycle Approach Resulting in Fewer Method Transfer Failures
- Knowledge Transfer A Critical Input to a Successful Method Transfer
- Transferring Analytical Methods Globally
- Building a Successful Method Transfer Team
- Risk-Based Method Transfer
