Question_Answer_Set_Four.pdf

Question and Answer Set Four

F17PS00726

1. Are there any specific lab accreditations needed for this program?

No specific lab accreditations are required in order to be awarded a contract.

2. Section 3.1/Quality Control states that the lab must conform with portions of the Good

Laboratory Practices (GLP) regulations from 40 CFR, part 160. Subpart B, 160.33 b,c,f and

160.35 a,b.6 describe the need for a Study Director and QA Inspector. Formal GLP projects require a GLP study protocol describing all activities and require approval by the facility’s study director and QA unit prior to testing. Is this considered an official GLP project? If yes, do the SOW and Solicitation documents serve as the GLP study protocol?

This is not an official GLP project. However the SOW and solicitation documents should be adhered to assure that all contract requirements are met.

3. SOW Section 3.1 – As the requirement for the QAPP specifies adherence to 40 CFR 160

GLP, are the laboratory analyses to be performed under GLP? The laboratory has a general lab QAPP which adheres to ISO 17025 and a separate QAPP which addresses the laboratory operations under GLP. Should both QAPPs be submitted with this proposal?

Laboratory analyses do not have to be performed under GLP but all analyses must adhere to the requirements of the Service stated in the SOW. The lab may submit the general lab QAPP which adheres to ISO 17025. Check before submission of the proposal that all requested information is included in the ISO 17025 that is required by the Service.

4. SOW Section 3.3, B.3 – This item indicates a minimum standard curve of 3 levels in addition to zero. Is the lab allow to calibrate per its laboratory procedures or must zero be included in the calibration curve?

Zero should be included in the calibration curve. This is the current standard for the Service for all current contractors and the Service will continue with this requirement for this newly awarded contract.

5. SOW Section 3.3, B.6 - Should the calibration be established using the curve run at the beginning of the run or should the two curves (run at the beginning and at the end) be averaged to establish the calibration?

The calibration should be established using the initial calibration curve run at the beginning of the run. Based on analytical acceptance of a data set there should not be a significant variation between the beginning and the end calibration curve. Therefore averaging of the two curves is not needed.