Aligning With the New Guidance: FDA Analytical Procedures and Method Validation | IVT

The recent FDA guidance document on analytical methods and validation is discussed. Key points in specific sections including Analytical Methods Development, Content of Analytical Procedures, Analytical Method Validation, Lifecycle Management of Analytical Procedures, and FDA Methods Verification are described. In order to assess company compliance with the new FDA guidance, a gap assessment tool should be created including guidance sections, requirements, remediation activity, and associated requirements.