2__GHSC_Quality_Assurance_-_Draft_PWS.pdf

Section C – Statement of Work Version 8‐15‐13 Section C.1 – Background

Please refer to Section J for a list of acronyms used throughout the entirety of this section.

The purpose of this contract is to serve as the primary vehicle through which USAID will help assure the quality of essential health products (EHP) procured in support of global health programs. This contract will provide for the design, development, and implementation of a comprehensive product Quality Assurance Program (QAP).

The United States Agency for International Development (USAID) is the U.S. Government’s principle implementing organization for international development assistance, but this contract can be called upon to serve the needs of multiple agencies. USAID is headquartered in Washington, D.C., and maintains field missions in numerous developing countries across the globe. USAID/Washington is comprised of five geographic bureaus (Africa, Asia, Europe and Eurasia, Latin America and the Caribbean, and Middle East) and four functional bureaus – (1) Global Health, (2) Economic Growth, Education and Environment, (3) Democracy, Conflict, and Humanitarian Assistance, (4) Bureau for Food Security – that conduct Agency programs globally.

The Bureau for Global Health is one such functional bureau with an overarching goal of improving human health.

The Bureau for Global Health portfolio includes programs and investments that represent the commitment and determination of the United States Government to prevent suffering, save lives, and create a brighter future for families in the developing world. Successful implementation of USG (United States Government) health programs in developing countries is dependent, in part, on an uninterrupted supply of quality EHP.

Procurement of quality EHP has, therefore, been a focus within the USAID Bureau for Global Health for over 30 years. Since 2005, USAID has procured and delivered more than 4,300 different products valued at over $2.4 billion to over 100 countries and provided supply chain assistance and capacity development support valued at $450 million to strengthen partner country health systems in over 50 countries. These activities support USAID’s Global Health Bureau vision “a world where people lead healthy, productive lives and where mothers and children survive and thrive” by increasing availability of quality EHP. An important priority for USAID is establishment of a mechanism to help assure that all EHP procured by the Agency are of acceptable quality.

The Bureau for Global Health includes three Offices that procure commodities for USAID programs and Presidential Initiatives globally; the Office of Health, Infectious Diseases, and Nutrition (HIDN), the Office of HIV/AIDS (OHA), and the Office of Population and Reproductive Health (PRH). These three offices plus the Office of Health Systems (OHS) provide technical assistance related to supply chain management, quality assurance, and commodity security.

These offices promote global leadership, provide technical support to field missions, and undertake research and innovation to achieve the Global Health Bureau’s health objectives.

Office of Health, Infectious Diseases and Nutrition (HIDN) – HIDN manages a diverse portfolio. It is responsible for managing the Global Health Bureau’s activities in child survival health, maternal health, and infectious diseases, which include tuberculosis (TB), malaria, avian influenza, and neglected tropical disease, and for providing technical leadership in each of these areas. The activities also include programs in nutrition/micronutrients, food security, health policy and health systems strengthening, child survival and health grants with NGOs, monitoring and reporting, and performance management. USG’s major malaria program is the President’s Malaria Initiative (PMI).

Although managed out of HIDN, it is implemented as a collaborative USG effort by both USAID and the Centers for Disease Control (CDC). PMI is a consortium of various USG entities and in addition to USAID and CDC, includes the Department of Health and Human Services, the Department of State, the Department of Defense, the White House, and others.

HIDN and PMI currently apply a comprehensive QAP to all EHP. The existing QAP, while comprehensive in scope, is also specifically tailored to the needs of a diverse set of EHP procured for program needs, ranging from malaria products to maternal and child health products. Under HIDN and PMI, implementing partners procure EHP approved by the United States Food and Drug Administration (USFDA), other stringent regulatory authorities (SRA) or EHP approved by the World Health Organization Prequalification Program (WHO PQP). EHP with these certifications are deemed safe, efficacious and of good quality. As needed, EHP are also purchased from pre‐approved USAID international wholesalers, having vetted quality assurance/control procedures enabling them to source from reputable vendors.

Even though products for malaria are not the only health related products procured within HIDN, most of the QAP activities support the PMI. As part of the QAP, every batch of every drug procured with malaria funds is subject to some level of quality testing at an ISO (International Organization for Standardization) certified or World Health Organization (WHO) pre‐qualified laboratory using applicable pharmacopoeial standards. These laboratories are located on several continents including Asia, Africa, Europe, and North America. Insecticide treated nets (ITN) and rapid diagnostic tests (RDT) for malaria are also subjected to quality testing to assure acceptable performance.

With the exception of ITN, all testing is conducted prior to the release of product from quarantine; test results are reviewed and approved by both the contractor and USAID.

All testing results of the QAP are kept on file for future reference. In addition, all Certificates of Analysis generated by the manufacturers are retained and filed.

The PMI began in 2006 with three countries and subsequently scaled up to 19 countries in sub‐Saharan Africa and one regional program in the Greater Mekong sub‐region by 2012. Similarly, funding scaled up significantly, totaling $578 million in FY 2011.

Commensurate to the increase in funding was a dramatic increase in the volume of products procured, all of which are subject to quality control testing processes.

Between 2006 and 2011, the following EHP were purchased for the PMI.

Product Value (Millions USD)

Insecticide Treated Bednets 59

Lifesaving Antimalarial Treatments 116

Rapid Diagnostic Tests 33

Intermittent Preventive Treatments 13

On a smaller scale, HIDN also oversees the procurement and related quality control testing of other EHP. These include essential medicines, drugs for neglected tropical diseases, and drugs for TB, among other EHP.

Office of HIV/AIDS (OHA) – OHA has primary responsibility for leading the Agency’s efforts within the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). This responsibility entails 1. ensuring the technical integrity of Agency and Mission strategies; 2. providing global technical leadership on the full range of issues related to HIV/AIDS prevention, care, and treatment; 3. managing numerous research and field support programs; 4. monitoring and reporting on the impact of the Agency’s HIV/AIDS program; and 5. ensuring the supply of quality essential medicines and other products to people impacted by HIV. (Human immunodeficiency virus infection) and to promote sustainable supply in partner countries, in collaboration with US agencies and other stakeholders. PEPFAR has provided care and treatment for over 5 million persons living with HIV/AIDS and strives to achieve a goal of 6 million patients on treatment by the end of 2013.

As part of PEPFAR, the Supply Chain Management Systems (SCMS) project was established to provide a secure, reliable supply chain for EHP. Since 2005, SCMS, managed by OHA/Supply Chain for Health (SCH), has procured approximately $1.5 billion of EHP to support global HIV/AIDS programs. A robust QAP for EHP has been implemented. Extensive efforts have addressed all aspects of quality assurance including quality control, vendor pre‐qualification, technical assistance, global collaboration, and technical leadership.

Quality control activities currently being conducted by the incumbent QA (Quality Assurance) contractors include a risk‐based sampling, testing, and release system for medicines. QA systems to evaluate the quality of other products such as rapid diagnostic tests, other laboratory tests, and food products have also been implemented. In most cases, quality control testing is conducted in WHO prequalified or ISO certified laboratories located in Africa, Asia, or North America. In addition to product quality control, a vendor pre‐qualification program has been implemented to provide additional confidence that products purchased meet USAID quality standards. This program has greatly increased access for critical EHP needed by PEPFAR. Currently, six international wholesalers have been pre‐qualified to serve as vendors for EHP for USAID.

SCH manages services for products that are purchased for at least 40 countries worldwide. During the period 2005–2012, approximately $800 million has been spent to procure ARVs (Antiretroviral drugs), $130 million for HIV rapid test kits, $270 million for laboratory equipment/commodities, and $60 million for essential drugs. These EHP have been subject to the existing QAP program that serves to help assure that these products meet USAID quality standards. As PEPFAR continues to scale up to meet treatment targets, these procurement volumes will continue to increase.

Office of Population and Reproductive Health (PRH) – PRH provides strategic direction, technical leadership, and support to field programs in population, voluntary family planning, and reproductive health. It manages programs that advance and apply state‐ of‐the‐art technologies, expand access to quality services, promote healthy behaviors, broaden contraceptive availability and choices, strengthen policies and systems to address family planning and reproductive health needs, and improve data collection and use. USAID continues to support family planning programs in approximately 50 countries, while allocating the bulk of family planning funding to 24 priority countries.

These 24 countries have high levels of unmet needs for family planning, limited modern contraceptive use, and high numbers of high‐risk births.

Within PRH, the Commodities Security and Logistics (CSL) Division manages the current QAP for contraceptives, condoms, and other EHP. The incumbent QA Contractor implements a risk–based QAP that includes supplier surveillance activities, good manufacturing practice (GMP) inspections, periodic plant visits, and independent sampling and testing. Currently, the incumbent QA Contractor operates an independently certified quality control laboratory to test physical and chemical properties of EHP and utilizes additional laboratories if needed. These facilities are located in Asia and North America. The incumbent QA Contractor also maintains a database of all test data, quality technical documentation, and relevant QAP documents. Key data analyzed by the incumbent QA Contractor include supplier performance on identified quality indicators, summary test information, process capability values, statistical control charts, reports on surveillance audits, and product complaints. Summary reports and information are provided to CSL on a routine basis as a contract deliverable.

In addition to the above outlined activities, the incumbent QA Contractor provides global technical leadership in the quality arena and capacity building on regulating and assessing the quality of medicines. The incumbent QA Contractor also provides CSL with technical advice regarding product specifications and technical requirements for purchase agreements.

Finally, as part of the current QAP program, the incumbent QA Contractor conducts post acceptance/shipment sampling and testing of products throughout the supply chain (i.e.

during transport, warehouses, service delivery points). The incumbent QA Contractor also collaborates with manufacturers and relevant global stakeholders regarding issues which arise such as responding to product complaints, conducting investigations, and supporting product recalls.

Since 2007, approximately 137 million injectable, 412 million cycles of oral contraceptives, 2.6 million contraceptive implants, 4 million IUDs (Intrauterine Device), 64 million female condoms, nearly 4 billion male condoms, 17 million sachets of lubricant, and 1 million cycle beads have been provided to over 50 field programs worldwide. In fiscal year 2011 alone, the total product value of contraceptive and condom shipments to field programs exceeded $100 million. The incumbent QA Contractor has tested 100% of lots of male/female condoms, IUD and personal lubricant, and approximately 10% of hormonal contraceptive to assure quality.

Office of Health Systems (OHS) – The newly created Office of Health Systems leads the development of USAID’s agenda and strategy to promote effective, sustainable, country‐owned health systems capable of advancing maternal, neonatal and child health and nutrition; combating infectious diseases including HIV/AIDS, malaria, TB, and neglected tropical diseases; and addressing emerging public health priorities. OHS leads the Agency’s health systems research efforts including development of a research portfolio and of metrics and tools for measuring health systems improvements. It tracks and works to align USAID funds and programs for health systems strengthening with this agenda. OHS also works to influence the priorities of others to support this agenda and strategy, including other US government agencies, host country governments, donors, firms, and civil society. The goal of the OHS is to provide worldwide leadership and technical expertise in health systems strengthening.

The four offices described above currently work with various implementing partners to address quality assurance issues and help assure that EHP procured by USAID meet applicable standards. The current mechanisms that currently conduct a range of quality assurance activities are described in brief below.

USAID|DELIVER PROJECT – The USAID|DELIVER PROJECT provides global procurement and delivery of EHP as well as technical assistance in many of the countries where these products are consumed. The project designs, develops, strengthens, and, on request, operates safe, reliable, and sustainable supply systems that provide a wide range of affordable EHP, including drugs, diagnostics, and other health supplies to clients in country programs. Specifically, EHP, purchased by the USAID|DELIVER PROJECT, includes contraceptives, condoms, malaria treatments, insecticide‐treated bed nets, rapid diagnostic tests, essential medicines, as well as select commodities for HIV/AIDS, maternal and child health, infectious diseases, avian influenza, and other emerging pandemic threats. Refer to Section J for the latest Indefinite Quality Contract (IQC) annual report for the USAID|DELIVER PROJECT.

Preventive Technologies Agreement (PTA) – PTA, among other things, implements USAID’s comprehensive quality assurance program for all contraceptives and condoms procured and provided by USAID worldwide. This includes a wide range of product quality assurance and technical assistance activities. Product quality assurance activities include development and review of technical specifications, pre‐shipment product sampling and testing for condoms and IUDs, confirmatory testing for hormonal contraceptives that are approved by the USFDA, a Stringent Regulatory Authority (SRA) or WHO PQP, review of manufacturer quality documentation for all contraceptives and condoms, performing stability studies, and conducting manufacturing audits. Technical assistance activities include conduct of investigations regarding product quality issues or issues of diversion, theft, counterfeit, and substandard products, assessments of testing laboratories, development of standard operating procedures (SOPs), and development of risk‐based quality assurance strategies.

Supply Chain Management Systems (SCMS) – SCMS delivers essential lifesaving medicines and products to HIV/AIDS programs around the world as part of PEPFAR.

Through 13 international organizations, SCMS works to strengthen supply chains to enable the scale‐up of HIV/AIDS care and treatment in developing countries. SCMS operates a safe, secure, and reliable supply chain to buy and distribute high‐quality, low‐ cost essential medicines, HIV test kits, laboratory supplies and other products. SCMS strengthens the capacity of national supply chains to ensure long‐term sustainability.

SCMS supports supply chain collaboration and information‐sharing among global and local partners in the HIV/AIDS community. As described previously, SCMS implements a comprehensive QAP for HIV/AIDS EHP.

System for Improved Access to Pharmaceuticals (SIAPS) – SIAPS aims to ensure the availability of quality‐assured pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes by applying systems‐strengthening approaches and principles of country ownership, integration of health programming, sustainability, and improved performance metrics. The SIAPS result areas address the intersections of five health systems components (governance, human resources, information, financing, and service delivery) as they relate to medicines policies, management and use, including a focus on patient safety and therapeutic effectiveness.

Potential interventions are designed to ensure that they respond to health element and cross‐cutting concerns in support of health system strengthening.

Promoting the Quality of Medicines (PQM) – The PQM program works to strengthen quality assurance mechanisms at the country level. It does so by improving medicines quality control laboratories and systems for monitoring the quality of medicines in the marketplace, in addition to collaborating with worldwide efforts to combat counterfeit and substandard medicines. The latter includes support for regional initiatives to develop regulatory capacity, sharing of information on product quality, and developing improved tools and approaches to detect counterfeit and substandard medicines. PQM is working as well to expand the pool of WHO PQP manufacturers of second line TB medicines.

QAP Capacity Building Services to Host Countries

USAID is committed to strengthening quality assurance systems in developing countries and supporting sustainable approaches to capacity building that are aligned with country priorities.

Many developing countries lack the structures and systems required to regulate EHP. Limited technical expertise, insufficient infrastructure, and a paucity of policies outlining the regulation of medicines contribute to countries’ inability to ensure and safeguard the quality and safety of medicines in circulation.

To address such lack of infrastructure, capacity building efforts have been undertaken by incumbent contractors of HIDN, OHA, and PRH. For example, the incumbent QA Contractors have provided technical assistance to host countries (primarily the national drug regulatory authority), in order to: 1. strengthen drug registration processes; 2. support compliance with international standards; 3. provide technical staffing; and 4. assist with complaint resolution.

USAID has also directed the incumbent QA Contractor to second employees to Ministries of Health where transfer of knowledge has improved country performance in procurement and quality assurance. In addition, the incumbent QA Contractor provides technical assistance and support to national laboratories on issues relating to laboratory setup and operations, test methods and sampling protocols. Specifically, the incumbent QA Contractor has also facilitated testing laboratories to participate in inter‐laboratory proficiency studies. The incumbent QA Contractor also provides capacity building regarding procurement and warehouse operations in partner countries with particular attention to appropriate procurement and receiving of quality assured medicines and products.

Technical Leadership

As a result of their expertise on a breadth of technical issues, QA professionals working with the incumbent QA Contractor have established a reputation as global technical leaders in EHP quality assurance. The incumbent QA Contractor has played an active role in revising the World Health Organization Model Quality Assurance System audit checklist, validating shelf‐life and stability data of EHP, completing method transfers, conducting and participating in inter– laboratory studies, and collaborating on clinical studies. Through these activities, the incumbent QA Contractors have been able to transfer knowledge to drug regulatory authorities in partner countries and serve as a resource to national laboratories.

Under the PMI, the Task Order 7 Malaria group has implemented a stringent quality assurance/quality control program, recognized by international donors and malaria partners as a program that takes the necessary inward‐looking and self‐policing steps to ensure products of good quality are procured. The procurement and appropriate management of malaria commodities necessitates expertise across several technical fields; the PMI is an integral part of global level policy setting, coordinating malaria control efforts with the WHO, the Global Fund and the World Bank.

In collaboration with the Tanzanian government, OHA has implemented an innovative solution related to testing the quality of pharmaceuticals in the field. Near infrared spectroscopy technology was implemented by the incumbent contractor that streamlined the drug quality testing process, increased efficiency of testing, and reduced overall costs of the QAP.

Global Collaboration

Due to their technical expertise, OHA and PRH and the incumbent QA Contractors have collaborated successfully with global partners regarding EHP quality assurance issues. These global partners include the Global Fund (GF), the WHO, UNITAID, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the United Nations Population Fund (UNFPA), standards bodies such as ASTM International and the ISO, and others. USAID and incumbent QA Contractors have worked with global partners to identify product quality issues, share information, and develop strategies to address product quality issues. Currently, global collaborative efforts are underway to harmonize donor quality requirements for pharmaceuticals and other EHP. Through these collaborations, the incumbent QA Contractors have developed a global leadership role in EHP quality issues and a reputation for expertise in the international QA arena.

Proposed New Architecture for the Global Health Supply Chain

USAID is restructuring its existing portfolio of projects related to commodity security and supply chain management of EHP. A diagram of the new portfolio of projects is shown below. This request for proposal is for the “Product Quality Assurance” contract. The architecture for the restructured portfolio is illustrated in Figure 1 below.

Of critical importance to USAID in the transition to these contracts from the incumbent contractors is ensuring an uninterrupted supply of commodities, a continuous provision of technical assistance, continuous product quality assurance, and a complete knowledge transfer between the existing implementing partners and the new implementing partners. To this end, this new contract is expected to operate in parallel with the existing contracts for a sufficient period of time to ensure a successful transition. This will require all existing and new contracting parties to collaborate as directed by USAID in support of the overall mission of improving global public health. The QA contractor should describe their plans to ensure a successful transition of these contracts in their proposal.

C.2 – Objective and Guiding Principles

The overall objective of this contract is to establish and implement a comprehensive QAP.

This QAP will assure that EHP purchased by the Agency meet applicable quality standards, provides global technical leadership regarding quality issues to the international quality assurance community, and provides technical assistance to partner country governments and other stakeholders. The QAP will need to be comprehensive in order to accomplish this overall objective, and incorporate all of the related activities required by HIDN, OHA, and PRH. To the greatest extent possible, activities that impact multiple disease elements will be conducted in a coordinated manner. While malaria related quality assurance activities are anticipated to be independent of this requirement and will be implemented through the Procurement and Supply Chain Contractor, the QA Contractor should have the capacity to absorb these activities if necessary. It will be important for the QA Contractor to apply a risk mitigation philosophy and strategy when determining the appropriate level of quality control activities.

All components of the QAP including quality control, capacity building, and global technical leadership in the quality arena, should represent the best value for the USG. Timeliness is a critical aspect in the provision of all components of the QAP, particularly in sampling, testing, and rendering quality decisions to the Procurement Contractors. The QA Contractor shall offer competitive costs, and prices shall be comparable to the lowest rates offered by commercial service providers. Whether through commercial services or through alternate means, new and innovative approaches to improve the QAP should be continually explored and implemented as appropriate.

The QA Contractor shall exhibit technical leadership and provide technical assistance to partner countries that complements, benefits, and coordinates with efforts in USAID health programs.

Furthermore, it will be important for the QA Contractor to maintain relationships with quality assurance professionals of other international health organizations and national drug regulatory authorities in partner countries, streamlining efforts with these organizations when appropriate and/or feasible.

NOTE: Quality Assurance activities for Malaria products and other EHP that will be procured under Task Order 1 of the Procurement and Supply Chain Assistance IQC will be performed by the Task Order 1 Contractor. The QA contractor will provide QA services for Task Order 1 only if specifically requested by USAID.

C.3 – Scope of Work (SOW)

Components of the Overall Objective

To accomplish the overall contract objective, the QA Contractor shall address the following components:

I. Establish a comprehensive QAP for the Bureau for Global Health: The QA Contractor will establish a QAP with appropriate standard operating procedures that are compliant with applicable USG and USAID regulations, policies and other requirements regarding quality standards for EHP.

II. Design and implement a Quality Control (QC) strategy that provides for appropriate monitoring of the quality of EHP procured by USAID. For all EHP procured by USAID, the QA Contractor will establish and maintain comprehensive QC activities as part of the overall QAP. QC activities shall include sampling of products, transporting of samples, identifying appropriate laboratory testing facilities, monitoring results of testing, and implementing actions based upon the results of QC testing.

III. Provide and exhibit technical leadership in quality assurance and drug regulatory processes and utilize technical knowledge to engage with and provide technical support and training to host governments, USAID staff, and partners. The QA Contractor shall undertake efforts to institutionalize QA best practices in partner countries and work towards sustainable QA activities.

IV. Engage global partners and forge partnerships within the quality assurance discipline to collaborate, share information, and develop harmonized approaches to assuring the quality of EHP. USAID and the QA Contractor shall interface with international organizations, nongovernmental organizations, academic institutions, and work with other key stakeholders to address global quality assurance issues of mutual concern.

V. Interface with all Procurement Contractors under the Global Health Supply Chain Architecture (Procurement and Supply Chain Assistance Contractor, Laboratory Contractor and Business Intelligence Contractor, to be referred to as Procurement Contractors for the remainder of this document) to ensure that procurements of EHP are completed in adherence with applicable USG and USAID regulations regarding product quality and are in‐line with the established QAP.

C.4 Detailed Technical Specifications

I. Objective 1: Establish a comprehensive QAP for the Global Health Bureau

The QA Contractor will implement and sustain a comprehensive QAP that is capable of addressing the requirements of USAID GH, particularly of the Office of HIDN, OHA, and Office of PRH. For the purposes of this contract, the term ‘QA’ is defined as the sum of all the activities and processes required to ensure that medicines and products are safe, effective, and of acceptable quality for clients and patients. Collectively, these activities serve to mitigate risks to both the patient/recipient and USAID.

For the purpose of this contract an essential health product (EHP) includes the following:

1. Pharmaceuticals

a. Antiretroviral medicines

b. Antimalarial medicines

c. Antimycobacterial medicines (medicines to treat tuberculosis)

d. Medicines to treat opportunistic infections

e. Other anti‐infective medicines

f. Hormonal Contraceptives

g. Essential medicines

2. Ready to Use Therapeutic/Supplementary Foods (RUTF)

3. Laboratory equipment, reagents, and consumables

4. Insecticide Treated Bednets

5. Condoms and Intrauterine Devices

6. Rapid Diagnostic Tests (RDTs for HIV, Malaria, TB, etc.)

7. Kits for Voluntary Male Medical Circumcision

8. Medical supplies (gloves, gowns, etc.)

9. Medical Equipment (hospital beds, etc.)

10. Other products as requested

Within 60 calendar days of contract award, the QA Contractor must design and implement a comprehensive QAP for GH which balances the probability of the occurrence of product defects and patient harm, the severity of the harm, and the resources required and available to assure quality. As such, the QA Contractor shall develop a risk‐based strategy and approach to quality assurance that will serve to minimize cost, ensure compliance to specifications and other contract requirements, and mitigate risks for patients and for USAID. The QA Contractor shall deliver best value to USAID and demonstrate prices are competitive when compared to prices available from vendors in the commercial sector. The overall QAP will, at a minimum, address key activities aimed at assuring the quality of EHP. The QA Contractor will create detailed and explicit SOPs, and such SOPs will address all aspects of the QAP. Additionally, the QA Contractor should propose a robust and resilient plan in order to rapidly respond to urgent issues throughout the life of the contract.

The QA Contractor shall undertake new QAP activities as the requirements for health programs and healthcare product needs evolve. The QA Contractor shall propose innovative enhancements to these activities or propose new QAP activities that would improve the effectiveness or efficiency of the USAID QAP. The following key activities have been prominent in the USAID QAP to date, however this is not a comprehensive list:

1. Assuring compliance with USAID policies and regulations (e.g. ADS 312)

2. Pre‐qualifying wholesale distributors and manufacturers as approved sources for USAID funded EHP

3. Maintaining a robust strategy of QC activities

4. Assisting in the registration of EHP in target countries

5. Developing product recall procedures

6. Engaging in pharmacovigilance efforts as requested by USAID

7. Convening external advisory groups as requested

USAID Policies and Regulations

A number of policies and regulations exist that govern USAID procurements and quality standards. Specifically, ADS 312 (Eligibility of Restricted Products), and 22 CFR 228 (Rules on Source and Nationality for Products and Services) contain the USAID policy directives that regulate procurement of restricted products, including pharmaceuticals and other medical devices (i.e. condoms). Although under this contract the QA Contractor will not undertake procurement of EHP for distribution purposes, the QA Contractor will be required to maintain close communication with the Procurement Contractors in order to help USAID ensure compliance with applicable requirements regarding quality through conference calls or meetings on a monthly basis at a minimum. Some EHPs have been pre‐approved by USAID (i.e.

ARVs, RTKs for HIV). For EHP that has not been pre‐approved by USAID, the QA Contractor will be required to communicate USAID approval to the Procurement Contractors prior to purchase.

In order to avoid stock‐outs or delays, the QA Contractor shall conduct reviews of orders and render decisions to USAID and the Procurement Contractors within 5 business days, with the exception of urgent reporting at the direction of USAID. Details pertaining to the types of pharmaceuticals that can be procured are illustrated in the ADS 312 Help Document attached in the appendix.

Vendor Pre‐Qualification

While the quality of EHP is paramount, USAID is aware of the need to increase access to quality assured EHP. The increasing demand and the evolving landscape for health programs necessitates access to additional manufacturers and wholesale distributors that are capable of providing quality assured EHP for implementing partners. To this end, USAID requires the QA Contractor to identify potential quality sources in collaboration with the Procurement Contractors. The QA Contractor shall evaluate identified vendors, to be defined as a manufacturer or wholesale distributor, for compliance with quality standards and recommend approval or disapproval to the USAID COR (Contracting Officer Representative). Approved vendors are eligible to provide EHP to USAID implementing partners.

In order to appropriately undertake this vendor pre–qualification process, the QA Contractor will need to provide personnel that have the appropriate expertise and experience, as specified in Section L. Vendor pre‐qualification requires a thorough knowledge of good procurement practices, international drug and device quality standards, product dossiers, Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP).

For prospective international wholesale distributors, the QA Contractor will:

1. Within 60 calendar days of contract award, develop or adopt a standardized quality assurance checklist based on GDP to enable the QA Contractor and USAID to objectively evaluate vendors.

2. Within 90 calendar days of contract award the QA Contractor will propose an audit schedule for the upcoming quarter and will continue to propose quarterly schedules to undertake site visits to currently approved and potential wholesale distributors to conduct quality audits.

3. Prepare audit reports and present to the vendor and to USAID within thirty calendar days of the audit. The QA Contractor will monitor the implementation of recommended corrective actions as needed, based on an agreed upon timeline. Based on the results of the audit and any corrective actions taken, the USAID COR will make a determination regarding the status of the vendor to provide EHP to USAID.

As part of the vendor pre–qualification process, the QA Contractor shall maintain documentation and files for each wholesale distributor as a paper trail for pre–qualification activities. In the event an approved wholesale distributor is failing to perform to expectations, the QA Contractor will recommend corrective actions for USAID.

Similarly, for prospective manufacturers, the QA Contractor will:

1. Within 60 calendar days of contract award, develop or adopt a standardized quality assurance checklist based on GMP or relevant guidance to enable the QA Contractor and USAID to objectively evaluate vendors

2. Within 90 calendar days of contract award the QA Contractor will propose an audit schedule for the upcoming quarter and will continue to propose quarterly schedules to undertake site visits to currently approved and potential pharmaceutical manufacturers, and other types of manufacturers of EHP to conduct quality audits located mostly in Asia and Europe

3. Report corrective actions for deficiencies identified during the audit to the vendor and to USAID within thirty calendar days of the audit. The QA Contractor will monitor the implementation of corrective actions as needed and establish an appropriate timeline for completion. The QA Contractor will recommend to USAID that the manufacturer be approved or disapproved as a vendor for EHP.

The QA Contractor shall monitor and evaluate the in‐process quality controls of manufacturers of condoms and hormonal contraceptives and generate a report card on an agreed‐upon basis with USAID, but at least annually. This will be a deliverable of the QA Contractor. These report cards will track the quality performance of manufacturers, direct Procurement Contractors to appropriate sources, identify trends that could impact future product quality and enable the QA Contractor to proactively identify and raise issues with manufacturers.

The QA Contractor shall collaborate with other international organizations such as UNICEF (United Nations Children's Fund) and WHO on quality assurance activities and standards. The QA Contractor will review and evaluate quality assurance approvals from other international organizations and, if acceptable, USAID will approve potential vendors based on these reports.

Such collaboration with international partners will result in a reduction of duplicative effort and avoidance of significant costs.

Quality Control

Implementing and maintaining a comprehensive QC strategy is an integral part of the overall QAP. This task is required and is a critical and primary responsibility of the QA Contractor.

Elements of a comprehensive QC program are detailed in Section C.4. II below.

Documentation

The QA Contractor shall remain updated of information on US and international regulatory requirements pertinent to EHP procured for USAID funded programs and managed through the QAP. Specifically, the QA Contractor will interpret GMP, GDP and associated regulations and guidance as applicable to the QAP and review scientific documents, publications, product dossiers and other applicable documents, from a regulatory standpoint. The QA Contractor will review these documents and report the relevant findings to the USAID COR once a quarter as a contract deliverable. This effort requires that the QA Contractor maintain a database that manages relevant documentation as applicable such as:

1. Certificates of analysis

2. Test results

3. Product labeling and labeling changes

4. Relevant safety alerts

5. Regulatory status of relevant manufacturers with supporting documentation

6. Credentials for testing laboratories

7. Relevant product recall information

Product Recalls

Product recalls are an inevitable reality in a global health program involving the delivery of EHP.

Two types of recalls are likely to occur:

1. Recalls initiated by the manufacturer or

2. Recalls initiated by USAID at the recommendation of the QA Contractor, upon review of quality control testing results.

Within 60 days of contract award, the QA Contractor shall develop a drug recall classification system based upon the risk to the patient/recipient of the EHP in question. In the event of a recall, the QA Contractor will investigate the initial quality problem scale and as soon as feasible develop an action plan for managing and quarantining (if necessary) EHP in question, to include a communication strategy that informs necessary parties and determines appropriate steps.

Depending on the magnitude and classification of the recall, necessary parties may include, but are not limited to, USAID, the Procurement Contractors, USFDA, other USG agencies, WHO, GF, the applicable National Drug Regulatory Authority (NDRA), and others. The QA Contractor, in consultation with USAID shall determine the appropriateness of continued utilization of the manufacturer/wholesale distributor for future procurements. This may involve a GMP/GDP audit of the facility, after the recall has been resolved.

The QA Contractor shall provide advice to USAID and the Procurement Contractors regarding all aspects of the recall that are dependent on a quality determination. The USAID COR must approve all product recalls.

Pharmacovigilance

As an overall part of QAP, the QA Contractor may be requested to provide resources and technical consultation to countries or programs that are implementing pharmacovigilance (PV) activities as dependent upon specific country needs. Implementation of PV activities will require specific expertise on the part of the QA Contractor including previous experience in PV programs, preferably in developing countries. This activity will be implemented only upon request by the USAID COR. PV services may include technical assistance to the ministry of health or USG implementing partners and may include all or selected aspects of PV. Activities may include assisting in policy development, legal frameworks, regulations, systems and structures, risk assessment, evaluation, risk management, and communication. The USAID COR may require the QA Contractor to utilize other existing USAID mechanisms to provide PV services, i.e. SIAPS.

External Advisory Group

The USAID COR will require the QA Contractor to establish and maintain external advisory groups to review and provide consultation regarding the overall QAP. For example, an external advisory group shall meet at least annually and the group membership will be developed in collaboration with, and with the approval of USAID COR. Membership of an external advisory group may change over time as appropriate to the issues. The external advisory group will constitute 5 to 7 members and represent a number of diverse disciplines pertinent to the quality assurance field such as pharmaceutical chemistry, clinical medicine, statistics, industry, and regulatory affairs. Additional experts may be invited by the QA Contractor and/or USAID COR to meetings, if needed to address a specific quality related issue. External advisory groups may be consulted whenever required for advice and expertise in addressing quality issues as they are encountered by the QA Contractor.

II. Objective 2: Design and implement a Quality Control (QC) strategy that provides for appropriate monitoring of the quality of EHP procured by USAID.

The QA Contractor shall develop and maintain a comprehensive QC strategy as an integral part of the overall QAP.

General

The QA Contractor shall develop and implement a comprehensive QC strategy and program that is consistent with, and complementary to the overall QA objective identified earlier in this SOW (C.3‐II). This strategy will be developed within 90 days of contract award and the QA Contractor shall provide an annual review of the overall QA strategy to the USAID COR as a deliverable under this contract.

For the purposes of this contract, QC is defined as the process or processes concerned with EHP product specifications, sampling, testing, and release procedures. These activities ensure that the appropriate tests are executed and, in some cases, that EHP are not released into a supply chain until quality has been confirmed.

The QC strategy will be foundationally based upon a well–defined product and vendor–specific risk mitigation strategy that can detect and identify deficiencies. The QC strategy will define specific QC activities for these activities to assure that the quality of EHP procured through USAID adheres to well‐defined, internationally accepted quality criteria.

Standard Operating Procedures

Within ninety calendar days of contract award, the QA Contractor shall develop SOPs for all processes necessary to assure the quality of EHP procured for USAID programs and when directed by the USAID COR, those procured through other bilateral and other international partners. These SOPs shall be developed in close collaboration with technical experts from the USG that are designated by the USAID COR. The contractor shall deliver these SOPs and they shall be posted by the contractor though the BI mechanism. The QA Contractor shall ensure that these SOPs are updated regularly and in response to evolving demands of the respective technical areas, global policy updates, and any other relevant state–of–the–art developments.

This effort will require that the QA Contractor maintain a close collaboration with the Procurement Contractors and other appropriate USAID partners. This may also require the QA Contractor to collaborate with the mechanisms involved in the provision of supply chain and health systems strengthening technical assistance. As requested, the QA Contractor shall conduct quality control activities where USG funds are used to procure EHP and when needed by other USAID partners.

Sampling

As part of the overall QC strategy the QA Contractor shall arrange for the sampling, testing, and processing of EHP. Specifically, the QA Contractor shall develop and propose a risk‐based sampling strategy for each EHP including the appropriate sampling methodology within 90 calendar days of contract award. The sampling strategy shall identify risk levels for each EHP and propose corresponding sampling frequencies based on this determination. This comprehensive sampling strategy will include sampling at various points in a supply chain, including manufacturing site, in transit, or after delivery.

The QA Contractor shall be responsible for processing collected samples including secure, appropriate transport to the appropriate laboratory testing facility. Product–specific processes for transit (i.e. air, sea, and land) will ensure and maintain the security, quality and integrity of the samples. The QA Contractor shall provide documentation and services needed to assure transit and port clearance of samples. The QA Contractor shall maintain complete and accurate records and documentation at each step of the sampling process and must work closely with the Procurement Contractors in order to collect and ship samples.

Quality Control Testing

Quality control testing of EHP is a critical element of performance for this contract. The QA Contractor shall manage all elements of quality control activities including:

1. Ensuring that the proper quality tests are conducted and that test results are reported to all stakeholders. Test results requiring urgent action will be reported within one business day.

2. Reviewing and analyzing test results, and

3. Releasing products for use based on acceptable testing results. For products that are being quarantined, release will be approved within three business days of receiving acceptable testing results.

The QA Contractor shall respond to multiple, diverse and simultaneous demands for quality services across health elements, within the Global Health Supply Chain Architecture and other entities. Depending on the particular EHP, quality control testing occurs prior to or after the release of the EHP. An understanding of product‐specific technical requirements will form the basis by which quality control processes are developed. The following list of EHP specific testing will serve as examples of required testing capabilities.

1. Pharmaceuticals and Hormonal Contraceptives – i.e. full monograph, or separate analyses, and sterility according to monographs in the United States Pharmacopoeia (USP), the British pharmacopoeia (BP), or the International Pharmacopoeia (IP). In some cases an “in‐house” method may be used if appropriate

2. Rapid Diagnostic Tests – i.e. sensitivity, specificity, and compliance with all other requirements of the package insert

3. Ready to Use Therapeutic/Supplementary Foods– i.e. microbiologic testing, aflatoxin, and product composition

4. Condoms – i.e. physical inspection, air inflation, freedom from holes, package seal integrity, lubrication quantity

5. Insecticide Treated Bednets – i.e. physical inspections (visual, bursting strength), and assays to determine chemical content

Product Recall Reports

Out of specification (OOS) results will be reported to the USAID COR within three business days.

The QA Contractor shall take action to mitigate any risks to the patient or the US Government, as directed by the COR. This action may include consultation with a pharmacist at USAID (a list will be provided by USAID) and a product recall if directed by the COR.

Retention Store

The QA Contractor shall maintain a repository of retained product samples as directed by the USAID COR. The purpose of the retention store is to preserve sample batches of EHP procured by the Procurement Contractors. These sample batches may be required at a future date to confirm (or not) the quality of the product.

The QA Contractor shall store retained samples in a retention store facility, the location(s) of which will be decided and agreed to by both the QA Contractor and USAID within one hundred twenty calendar days of contract award. The retention store facility must meet the following minimum requirements:

1. Transfer retained samples from existing retention stores from the incumbent contractor to the new QA contractor.

2. Store retained samples in a suitable physical space under appropriate conditions, in acceptable location(s)

3. Present all samples available for subsequent inspection…