Recommendations from the Global Bioanalysis Consortium Team A8: Documentation

Abstract

The A8 Global Harmonization Team focused on the documentation needed to support both small and large molecule bioanalysis. Current regulatory requirements were compiled and compared. The scope of the team's discussions included the validation report, the bioanalytical report, study plans, raw data, and bioanalytical summaries for the common technical document (CTD). A common high-level table of contents for method validation and sample analysis reports is proposed. Suggestions have been made as to how the CTD can be standardized to improve usability and review. Additional comments have been made on reports of failure investigations, study plans, and raw data documentation. The recommendation is that no prescriptive guidelines are required in these areas but should be led by good scientific practices subject to particular circumstances.

Current Industrial Practices and Regulatory Requirements to Assess Analyte and Reagent Stability Using Ligand-Binding Assays

“…It is also important to establish standardized, well-controlled sample collection and handling procedures. Some reagents are subject to lot-to-lot variation, it is, therefore, important to document the quality of these reagents, usually in a form of Certificate of Stability or a memorandum [15][16][17]41,49].…”

Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team

“…In turn, many GBC HTs have now published their proposals under the umbrella of this manuscript [18][19][20][21][22][23][24][25][26][27][28][29][30] or report back on their discussions via the GBC website: http:// www.globalbioanalysisconsortium.org/Harmonizationteams/ as part of the progress and status reports given for each harmonization team. In turn, many GBC HTs have now published their proposals under the umbrella of this manuscript [18][19][20][21][22][23][24][25][26][27][28][29][30] or report back on their discussions via the GBC website: http:// www.globalbioanalysisconsortium.org/Harmonizationteams/ as part of the progress and status reports given for each harmonization team.…”