3__GHSC_Quality_Assurance_-_Questions_and_Answers.pdf

Request for Information USAID/ Global Health Quality assurance

Solicitation Number: SOL‐OAA‐13‐000999‐AC

1. Will the QA support outlined in procurement scope of work be part of overall QA mechanism or

Global Supply mechanism?

The QA support outlined in the Global Health Supply Chain scope of work is independent of the QA Contract and will only be implemented when the QA contractor is unable, for any reason to provide these services OR at the specific request of USAID. The exception is for malaria. Malaria QA activities will be conducted by the contractor in TO 1 (malaria task order) under the Global Health Supply Chain . Malaria QA activities will be implemented by the QA contractor ONLY at the specific request of USAID.

2. Reference page 13, 1st paragraph: Will the QAP be required to manage any of the elements of the

SIAPS and PQM projects for OHS?

No.

3. Reference page 13, “USAID anticipates that when this contract is awarded the primary responsibility for the quality assurance of malaria related products will be implemented by another USAID mechanism…” Is this a reference to the USAID |DELIVER PROJECT TO7 and the QA mechanism in place?

No, this is not a reference to the USAID|DELIVER PROJECT TO7. See response to question #1 above.

4. Reference Objectives 1‐4: Does USAID/GH envision a QA structure consisting of four distinct QA task orders based on these 4 objectives?

No, the QA contract does not have Task Orders.

5. How are related activities for HIDN, OHA, and PRH that are pertinent to QA activities anticipated to be coordinated, such as GMP inspections?

To the greatest extent possible, activities that impact multiple disease elements will be conducted in a coordinated manner. Bidders are expected to propose how these activities will be coordinated in order to achieve best value for USG. The exception is for Malaria.

Malaria QA activities will be conducted by the contractor under the Global Health Supply Chain and will be not be implemented by the QA contractor except at the specific request of USAID.

6. Does the list in Appendix A include any GMP inspections for the malaria project?

No.

Request for Information USAID/ Global Health Quality assurance

Solicitation Number: SOL‐OAA‐13‐000999‐AC

7. Is it expected that the QA contractor will provide additional product testing support (ex. accelerated stability)?

Yes. For example, some product stability studies may be required. Please see Objective 3, Technical Leadership.

8. How will urgent issues be handled within this agreement? Will the agreement allow for rapid responses to QA, QC and TA issues through‐out the life of the project?

The scope of work requires bidders to respond to how best to address urgent quality issues. See Section C.4.1.

9. Who is responsible for establishing the interface between QA and BI (is there a lead or is it collaborative and/or will USAID serve in this role)?

This is a collaborative effort. The QA and BI contractors will have to work together to establish format and data structures that both contractors agree upon. The QA contractor will be responsible for creating compatible data files that are regularly extracted by the BI contractor. The BI contractor is responsible for creating the data link, extracting the data from compatible QA contractor files, and importing the data into the data warehouse.

10. Is the QA contractor or the BI contractor responsible for ensuring that the electronic data links between the two organizations are compatible? Which organization is responsible to harmonize the linkages if they are not?

The BI system will be a Commercial off the shelf (COTS) product and compatible with major vendor software systems. If the QA contractor's system is not compatible to establish an electronic data link or file exchange with the BI contractor, then the QA contractor will be responsible for modifying their system to enable this compatibility. If the QA contractor anticipates difficulty in enabling this compatibility, then the QA contractor must explain in their proposal why this is anticipated to be a problem and how they intend to enable the data exchange with the BI vendor. We expect the QA contractor to budget time and level of effort to comply with the data exchange requirement.