Solicitation / Requisition No.: 01B68-17-0132 Page 1 of 7 EVALUATION GRID RATED REQUIREMENTS Proposer / Firm: ______________________________________________ Insert Rated Criteria Score Evaluator: _______________________________________ Comments Rated #1: (5 pts) Describe the team to be assigned to this project, their responsibilities and how they will be accountable Company profile and history performing GLP pesticide residue studies (1 point) Identification of project PI, TSM, QA, technician(s) and their roles (supported by CVs and GLP organization chart) (2 points) Accountability (1 point) List of analytical instruments to be used in the project (1 point) 1 Solicitation / Requisition No.: 01B68-17-0132 Rated #2A: (50 pts total 2a and 2b combined) Provide details of direct experience with each crop fraction listed in Appendix B, Annex 1 for this project; outlining any residues of concern analyzed and indicating the number of studies with each fraction. Provide details of direct experience with each component of the residue definition listed in Appendix B, Annex 1 for this project; outlining any crop fraction analyzed and indicating the number of studies with the residue definition. Confirm experience with the exact analytical method(s) listed in Appendix B, Annex 1, including any crop fraction analyzed. Provide details of conducted Frozen Storage Stability Studies. Page 2 of 7 Crop Matrix (20): Experience with same crop fraction as project (10) Quantify experience with the matrix (10). Residue Definition (20): Experience with same Residue of concern (analytes) as project (10) Quantify experience with Residue Definition (10). Experience/ methodology (10) Note: If applicant meets requirements of part 2a, then part 2b does not apply. Maximum points 50. Experience with same methodology as listed for project (10) 2 Solicitation / Requisition No.: 01B68-17-0132 Insert Rated Criteria Page 3 of 7 Score Comments Rated #2B: (50 pts total 2A and 2B combined) Experience with other Matrices that will be beneficial for this project, and why (15) Provide details of related/similar experience with each crop fraction listed in Appendix B, Annex 1 for this project; outlining the residues of concern analyzed and indicating the number of studies with each fraction. Describe why this experience is relevant to this project. Provide details of related/similar experience with each component of the residue definition listed in Appendix B, Annex 1 for this project; outlining the crop fraction analyzed and indicating the number of studies with the residue definition. Describe why this experience is relevant to this project. List analytical method(s) similar to the one that is to be used for analysis of the residue definition in the crop fraction specified in Appendix B, Annex 1. Describe similarities of procedures between the methods and explain why it is relevant to this project. Experience with crop fractions similar to that of the project (5) Experience with other Residue Definitions that will be beneficial for this project, and why (15) Experience with similar Residues of Concern (5) Note: If applicant does not meet requirements of part 2A (direct experience), they may provide other relevant experience in part 2B. Maximum points of part 2A and 2B combined is 50. Maximum if only completing part 2B (no direct experience) is 40 points. Quantify experience with similar crop fractions and why they are relevant to this study (10) If no direct experience with the Residues of Concern of the project, applicant must provide experience with other relevant RD(s) and rationale as to why it’s relevant (10) Experience with similar analytical method(s), and why (10) Experience with similar analytical methodology (5) why its relevant (5) 3 Solicitation / Requisition No.: 01B68-17-0132 Insert Rated Criteria Rated #2C: (40 pts) Based on the reference method indicated in Appendix B, Annex 1, provide an overview of the procedures to be used for each study in the project. This overview is to include a summary/description of the analytical techniques needed to complete this analysis and why they are relevant (ex. Soxhlet extraction used to extract ethofumesate from sample). Explain calculations of the results. Based on the method, estimate the timeframe for analysis and indicate key stopping points. Provide proposed modifications, and explaining why they are required (ex. method required packed column with GC/NPD determination or equipment is not capable of handling packed columns). Include concerns/restraints. If proposed changes are not acceptable to PMC, can you follow the method as written? Page 4 of 7 Score Comments Understanding of the Analytical Methodology. (40) Outline of analytical method, providing details on how the lab will analyze samples. (Differences from the reference method are to be documented below) From a chemistry point of view, describe how the residue of concern is isolated from the matrix to injection vial and analyzed. If applicable, include details for phase transfers, degradations, adsorptions, column retentions, solubility, etc. For instances where derivatizations, transformations, enzymatic reactions, etc., occur, provide details of the chemical reactions. (30) Provide proposed modifications to the analytical method, Including justification for the changes. (10) Rated #2D (30 pts) Based on the draft study plan template and the information provided in Appendix B, Annex 1, provide an outline of the procedures to be used for each study in the project. This outline is to include details on each phase of analysis (including estimated time frame, number of sets, set composition, etc.). For each phase of analysis, outline and explain any potential concerns and include possible solutions. Outline of method validation process, including method validation extension (10). Outline of sample analysis process (including time frame, number of sets, etc.) (10) Outline of extract and standard stability (5) Outline of frozen storage stability analysis and requirements of each phase (5). Must address each phase of the study plan and identify any differences with reference method and/or lab SOPs as well as concerns/potential issues. 4 Solicitation / Requisition No.: 01B68-17-0132 Page 5 of 7 Result anomalies Rated #2E: (10 pts) Based on your SOPs and good scientific practices, provide guidelines for data reproducibility and outline how your organization handles inconsistencies in data or unexpected results, For example: a) quantifiable residue levels in an untreated sample on par with the levels in a treated sample; b) 1 trial with results significantly different than other trials within the study; c) one of the method validation recovery results is low (98, 95, 22%). Please outline any other types of inconsistencies which may be relevant to this study. Describe your raw data and report quality control procedures. Provide a copy of the relevant SOP(s) with the proposal. Insert Rated Criteria Rated #2F: (10 pts) Based on the LOD and LOQ in the reference method and your proposed changes (if applicable), is it possible to obtain similar, greater or lower sensitivity for this(these) crop fraction(s). How will the LOD and LOQ be determined? 10 pts for description of relevant SOPs and relevance to how organization handles inconsistencies. Score Comments Method LOD/LOQ 10 pts 5 Solicitation / Requisition No.: 01B68-17-0132 Rated #2G: (10 pts) Based on the draft study plan and reference method, provide an overview on how the reference items (analytical standards) will be prepared and stored. Outline any potential concerns, explaining why and providing potential solutions. Include information on solution stability. Page 6 of 7 Analytical standards 10 pts 6 Solicitation / Requisition No.: 01B68-17-0132 Insert Rated Criteria Page 7 of 7 Score TOTAL FOR RATED REQUIREMENTS : Minimum Overall Required Comments Out of 155 Points 93/155 (60%) Signature of evaluator: _______________________________________________ Date: __________________________ 7
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