Lines 944-947: table needs to include reasons for the new method or additional validation & dates of final reports. Comment: It is the interpretation that is this is a form of the CTD 943-947 table. Recommendation: That clarification be made if filing practices are not within the scope of this guidance. The items listed required in the summary table are related to filing and should not appear as 948-950 part of study data. Proposed change: Remove the summary table. C. Documentation for 952-954 Method Validation Lines 959 960: Clarification is needed as to whether this is a description of the – 959-960 preparation of standards and QCs OR a table of all prepared standards/QC batches and the dates of preparation. As this information is already present in the raw data and method it is Limit this requirement to a table of preparation dates. Recommendation: 961-964: Section is primarily chromatography focused. Recommendation: broaden the language to include LBA. Line 961: Only suitability of internal standard should be required. Removal of the requirement for evidence of purity and identity of IS Proposed change: 961-964 Line 962: States that the chromatogram of the analyte should be interference-free. No chromatogram can be totally interference-free. The current validation criteria that interferences, such as carryover and non-selective signal are allowed to the degree of 20% of the LLOQ. Proposed change: reword this requirement as chromatogram of the analyte should “The show interference that is below that set forth in the validation criteria.”
943-947 Lines 944-947: table needs to include reasons for the new method or additional validation & dates of final reports. Comment: It is the interpretation that is this is a form of the CTD table. Recommendation: That clarification be made if filing practices are not within the scope of this guidance. 948-950 The items listed required in the summary table are related to filing and should not appear as part of study data. Proposed change: Remove the summary table. 952-954 C. Documentation for Method Validation 959-960 Lines 959 – 960: Clarification is needed as to whether this is a description of the preparation of standards and QCs OR a table of all prepared standards/QC batches and the dates of preparation. As this information is already present in the raw data and method it is Recommendation: Limit this requirement to a table of preparation dates. 961-964 961-964: Section is primarily chromatography focused. Recommendation: broaden the language to include LBA. Line 961: Only suitability of internal standard should be required. Proposed change: Removal of the requirement for evidence of purity and identity of IS Line 962: States that the chromatogram of the analyte should be interference-free. No chromatogram can be totally interference-free. The current validation criteria that interferences, such as carryover and non-selective signal are allowed to the degree of 20% of the LLOQ. Proposed change: reword this requirement as “The chromatogram of the analyte should show interference that is below that set forth in the validation criteria.”
IQ_Comments_on_the_FDA_Draft_Guidance_for_Industry_Bioanalytical_Method_Validation.docx