Iamey/AbWEST AFRICAN HEATH ORGANIZATION PROCEDURE GUIDELINE FOR THE MANAGEMENT OF THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER STOCK

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1 Page 1 of 54 Iamey/AbWEST AFRICAN HEATH ORGANIZATION PROCEDURE GUIDELINE FOR THE MANAGEMENT OF THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER STOCK Addressee: West African Heath Organization (WAHO), Central Medical Stores in ECOWAS countries, National Drug Regulating Authorities, National AIDS Control Programs Release Date : Prepared by Reviewed by NAME AND TITLE SIGN DATE Dr B.G. Josias YAMEOGO, WAHO Consultant Pharm. Samuel BOATENG, WAHO Consultant APRIL 2013 Dr Carlos BRITO, PO HIV and AIDS/WAHO APRIL 2013 Approved by Dr Placido CARDOSO, Director General of WAHO West Africa Health Organization

2 Page 2 of 54 TRACKING OF CHANGES Date of creation: March 2013 Date of last update Concerned pages and paragraphs Editor s signature Approver s Signature West Africa Health Organization

3 Page 3 of 54 FOREWORD This procedure guidelines is part of a process initiated by the West African Health Organization (WAHO), in partnership with the JURTA PSM Group (Comprising UNAIDS, WHO, UNICEF, OCEAC and ECOWAS/WAHO) in organizing mechanisms for antiretroviral drugs (ARVs) buffer stock to mitigate any risk of stock out and ensure the continued availability and access to ARV drugs by people living with HIV/AIDS and are receiving treatment in ECOWAS countries. After the development of a technical document that describes the mechanism for troubleshooting, the size of the buffer stock and the eligibility criteria for the Collaborating Central Medical Store, The commissioned a team to carry out a review to help decide where best to locate a Regional Antiretroviral Drug buffer Stock and to propose procedure guidelines for the management of the stock. This procedure manual is the result of numerous discussions between experts, resource persons of WAHO and key persons of central medical stores visited. It is intended as an operational and suitable tool to be used by all involved in the management of the regional buffer stock. WAHO would like to express its sincere thanks to all those who have contributed directly or indirectly to the development of this document. The adoption of this procedure guideline by the Central Public procurement Agencies thus appears as a common commitment which will provide a basis of control, acceptable for all. Any difficulty encountered in the implementation should be notified to the WAHO department in charge of this process which will make arrangements for changes / revisions. DIRECTOR GENERAL WAHO West Africa Health Organization

4 Page 4 of 54 TABLE OF CONTENT TRACKING OF CHANGES... 2 FOREWORD... 3 TABLE OF CONTENT... 4 I. INTRODUCTION... 5 II SCOPE AND REFERENCES... 6 III. ABBREVIATIONS AND DEFINITIONS OF TERMS... 7 IV. CREATING STANDARD OPERATING PROCEDURES (SOPs) V. REVISION AND UPDATE VI. STANDARD OPERATING PROCEDURES (SOPs) Standard Operating Procedure for Coordination and Information Management System Standard Operating Procedure for Reporting, Forecasting and Quantification Standard Operating Procedure for Procurement process management- placement of drug orders Standard Operating Procedure for receiving and storage of drugs of the regional buffer stock Standard Operating Procedure for inventory management of the regional buffer stock Standard Operating Procedure for record keeping for WAHO-funded antiretroviral drugs at ARV bulk store Standard Operating Procedure for quality assurance Standard Operating Procedure for early warning and requesting ARV drugs from regional ARV buffer stock Standard Operating Procedure for administrative management Standard Operating Procedure on Financial Procedure APPENDIX... 46

5 Page 5 of 54 I. INTRODUCTION This procedure guidelines aim to organize the functioning and the management of the regional antiretroviral drugs buffer stock. It allows the use of a single framework to establish the relations among all stakeholders involved in the process of implementing the buffer stock and the definition of WAHO actions towards central medical stores in ECOWAS countries in case of urgent requests for ARV stock.. It takes into account the following broad objectives: - Efficiency gains in the execution of tasks, - Ensuring continuity in the functioning of the process, - Management tool, - Key control instrument. This procedures guide will be the reference tool for WAHO, the Collaborating central medical store and the other central medical stores within ECOWAS, in the implementation, management, application and mobilization in case of emergency and monitoring of the buffer stock. It aims to: - Optimize the inventory management of the regional antiretroviral drugs buffer stock, - Ensure good coordination between WAHO and the different actors involved in the process, including the Central medical stores and Procurement Agencies in ECOWAS countries, - Ensure an information system that can provide reliable data on the status of stocks of ARV drugs necessary for urgent decision making, - Promote cooperation, coordination and exchange of information between Member Central medical stores/ Procurement Agencies on one hand and the central medical stores/ Procurement Agencies and WAHO on the other hand. It describes the functioning and management of the buffer stock through the definition of the various procedures relating thereto. It also includes sections on definitions and scope. It is presented in loose-leaf form to facilitate handling and especially the necessary updates. The different procedures have been done to reflect the practices in the host central medical stores in order to allow for safe integration of the buffer stock into the National stock.

6 Page 6 of 54 II SCOPE AND REFERENCES 2.1 Scope of Guide The procedures for the management of the regional antiretroviral drugs buffer stock of the (WAHO) applies to all activities and services provided through the establishment, coordination, inventory management and the trigger of troubleshooting in case of alert. It covers all activities described in this guide as well as institutions or national or regional establishments and their staff involved in its implementation. 2.2 References This Procedures Manual is established with reference to: - Good storage and preservation practices of pharmaceutical products, - Good distribution practices of pharmaceutical products, - Legislation and laws in force in the countries of the ECOWAS, - Procedures for the (WAHO), - WHO Model Quality Assurance System (MQAS) for Procurement Agencies

7 Page 7 of 54 III. ABBREVIATIONS AND DEFINITIONS OF TERMS ARVs CTD ECOWAS GMP ISO MQAS MQS NDRA PO QA QC SOP WAHO Antiretroviral Common Technical Document Economic Community of West African States Good Manufacturing Practices International Standard Organization Model Quality Assurance System Management Quality System National Drug Regulatory Authority Purchase order Quality Assurance Quality Control Standard Operating Procedures - Procurement: The process of purchasing or otherwise acquiring any pharmaceutical product, vaccine, or other health products for human use. For the purpose of this document, procurement means the pre-selection of products and manufacturers through a procedure of qualification, including prequalification and continuous monitoring thereafter, purchase of the prequalified products from prequalified manufacturers (linked to the specific product) through defined purchasing mechanisms, storage and distribution. - Quality Assurance: Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. - Marketing Authorization: A legal document issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using INNs or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics. It specifies the information on which authorization is based (e.g. The product(s) must conform to all the details provided in your application and as modified in subsequent correspondence. ). It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. - Procurement Agency: Any organization purchasing or otherwise acquiring any pharmaceutical product, vaccine or other health products for human use. A procurement agency is defined as any organization purchasing pharmaceutical products, vaccines, or other health sector goods or otherwise involved in their prequalification, purchasing, storage and distribution.

8 Page 8 of 54 - Procurement agency collaborator/ central medical store Collaborator: Procurement agency/central medical store identified by WAHO to host the regional antiretroviral drugs buffer stock. - WHO certification scheme: A certificate of pharmaceutical product of the type defined in the WHO certification scheme on the quality of pharmaceutical products moving in international commerce - Quality Control: Quality control is concerned with sampling, specifications and testing, and with the procurement agency s documentation and acceptance/rejection procedures which ensure that the necessary and relevant tests are actually carried out and that starting materials, intermediates and finished products are not accepted for use, sale or supply until their quality has been judged to be satisfactory. - The logistic cycle: set of elements that can make available to users the products that they need to perform activities. - Document: Any written/recoverable information, which gives guidance (e.g. instructions including policy statements, manuals, reference values and their origins, procedures, specifications, tables, posters, notes, memorandum, plans, software, drawings, regulations and standards). - Procurement and stocks management (PSM): All management activities necessary to provide the end user quality products in sufficient quantities, purchased at the lowest price possible and in accordance with national and international law, and this in a safely and timely manner. - Indicator: Criterion used to measure changes, directly or indirectly, and to assess the extent to which the targets or objectives of a program or project are being attained. Indicators should meet the criteria of clarity, usefulness, measurability, reliability, validity and acceptance by key stakeholders. - Product information: information on pharmaceutical products submitted by manufacturers or suppliers in any of the formats specified in the procurement agency s guidelines (including product dossiers, product questionnaires or other formats) to obtain prequalification for the products. - Quality Management: Series of activities of the general function of management which determine quality policy, the objectives, responsibilities and implementation of these through measures such as planning, control, assurance and improvement of quality within the framework of the system. - Quality: Series of characteristics of an element, which make it capable of satisfying explicit and implicit requirements. - Quantification: This is the quantitative assessment of needs according to available resources.

9 Page 9 of 54 - Analytical report (certificate): Document, which contains the results of the analyses and any other information relating to the test. - Process: set of interrelated or interacting activities, which transform inputs into output elements. - Operating procedure: specified way to perform an activity or process. - WHO prequalification Program: program established by WHO, allowing it to prequalify the quality medicines whose purchase by United Nations specialized agencies is considered acceptable and the laboratory of quality control of drugs. - Selection: Consists of qualitative evaluation for an efficient selection of drugs according to the target groups and the national and international standard devices (Standard Therapeutic and Guidelines, Essential Medicines List). - Storage: action to warehouse, that is to say to place in a identified location objects or substances which it is desired to have available quickly if necessary

10 Page 10 of 54 IV. CREATING STANDARD OPERATING PROCEDURES (SOPs) This paragraph describes the procedure for creating standard operating procedures (SOPs) to apply to Regional buffer stock for ECOWAS countries for the duration of the program. The document is lay laid out in an orderly fashion with the contents in clearly defined sections to facilitate revision of any section without having to rewrite the entire document. Each SOP starts with the title of the SOP, which are descriptive, unambiguous, in a direct style to declare what is done in relation to what. The SOPs are easily identified by a unique serial number for each SOP. The system of numbering adheres to the following format: ARV-SS SOP##/Issue#.Revision# ARV-SS denotes an SOP related to antiretroviral drugs security stock SOP## refers to a unique, two-digit SOP number (i.e. SOP number 01, 02, etc) Issue# refers to the issue number for each SOP (i.e. issue number 1, 2, etc.) Revision# refers to the revision number per SOP issue (i.e. 0 for the first issue, 1 for the first revision, etc). For example, for the first SOP at the antiretroviral drugs security stock, issued for the first time with no revisions, thus it has been numbered ARV-SS01/1.0. The number of pages, the preparer s name and title, signature and date of finalization as well as the approver s name, title, signature and date of authorization are indicated. The date of issue of the SOP is the date it is approved for use. An objective is stated for each SOP. This objective provides a description of the overall goal of the SOP. A list of all persons who are responsible for understanding and complying with the actions listed in the SOP is provided. Any forms, tools, etc. that are necessary to complete the actions listed in the SOP are referenced in a separate resources section. Where SOPs bear procedural instructions, they are written as numbered steps which are clear, precise, unambiguous and use language that the user can understand. Where the SOP refers to other documents, a copy is provided of the document as an attachment to the SOP. Attachments are numbered in ascending order (i.e. Appendix 1, 2, etc).

11 Page 11 of 54 V. REVISION AND UPDATE 5.2 Revision of the Guide The procedure guidelines for the management of the WAHO antiretroviral drugs buffer stock will be made available to as many actors involved in the process of implementation of activities related to the ARV drug regional buffer stock. 5.2 Update of the Guide The procedures established in this manual must be followed consistently and rigorously. However, in order to improve on the system, updates could be considered as and when necessary to make it a real management tool. The responsibility for updating this guide lies with the Director General of WAHO or person designated by him. The guide is updated when: - The mechanism used to ensure the operation and / or management of security stock has been modified, - There are changes in how to proceed. Any proposed changes to the procedures established in this manual should be brought to the attention of the Director General of WAHO, by written notice, who will evaluate the timeliness and relevance. If the proposed amendment is considered appropriate and relevant, the Director General of WAHO will instruct the WAHO Program officer of the HIV / AIDS (responsible for the process) to prepare a draft amendment to be submitted to the heads of the institutions involved in the implementation of the procedure in question. The proposed amendment will be accompanied by a Note Verbale containing the following information: - The existing procedure to be changed, and - The reasons for the change. The recommendations made by the officials specified above are collated by the WAHO Program officer of the HIV / AIDS, and then submitted to the Director General of WAHO for approval. An official report of change will be finally prepared by the responsible officer and must include all details, including the accompanying measures. After adoption of the final text, the responsible officer must ensure the distribution of relevant sections to all stakeholders.

12 Page 12 of 54 VI. STANDARD OPERATING PROCEDURES (SOPs) This section contains formalized procedures whose implementation meets the following objectives: - Define a formal framework for management and conduct of operations, consistent with the vision of WAHO; which is to improve the availability of ARV drugs in ECOWAS countries by meeting the urgent demands, capacity building and coordination of regional emergency system; - Increase the accountability of Central medical stores and other actors involved in the performance of specific tasks by a clear definition of roles, responsibilities and expected results; - Increase the accountability of the collaborating central medical store and WAHO in the effective implementation of the system and the management of the buffer stock; - Optimize reporting and information sharing; - Facilitate decision-making. - Implement a mechanism for effective monitoring and control. The different procedures established in this manual are: - SOP for the for Coordination and Information Management System; - SOP for reporting, forecasting and quantification; - SOP for procurement process management; - SOP for receiving and storage of drugs; - SOP for inventory management; - SOP for record keeping for WAHO-funded Antiretroviral drugs; - SOP for quality assurance; - SOP for early warning and requesting ARV drugs from regional ARV buffer stock; - SOP for Administrative Management. - SOP for Financial Management

13 Page 13 of Standard Operating Procedure for Coordination and Information Management System Number of Pages: 5 Serial number: ARV-SS 01/1.0 Prepared by: Reviewed by: Title: Title: Sign: Sign: Date: Date: OBJECTIVE: To allow for an efficient implementation and an optimal operation of the regional antiretroviral drugs buffer stock. Ensure proper coordination between the Central Medical Stores in ECOWAS countries and the different actors involved in the process. RESPONSIBILITY: - Director General of WAHO - Managers of the Central Medical Stores in ECOWAS countries - Managers of the national AIDS control Programs in ECOWAS countries RESOURCES: - Diagram of the coordination system - Web software for information sharing PROCEDURE: 1. Establishment of a system for coordination and management 1.1. A coordination and management system will be established to provide a formal framework for implementation of related activities and optimize the flow of goods and information for the regional buffer stock This system aims to promote exchanges between different actors in order to improve the overall management of the buffer stock upstream and downstream. It has among its objectives to optimize information visibility, coordination and facilitate follow-up requests in case of emergency Regional or national structures, members of the coordination and management system are: (WAHO);

14 Page 14 of 54 Central Medical Stores in ECOWAS countries; National AIDS Control Program in ECOWAS countries In terms of organization and human resources: Regional coordination is ensured by WAHO and managed by the Director General of WAHO. The WAHO program officer of HIV / AIDS will be responsible for the implementation and functioning of the process. The management of stock is ensured by the Central Medical Stores in the country that houses the buffer stock through the manager and the person in charge of the management of the ARV drug stock in collaboration with the Procurement agent and the responsible officers in charge of PSM and the National AIDS Control Program. In each of the other countries within the community, the responsible officer in charge of PSM in the National AIDS Control Program will be appointed as the focal point The system set in place will allow an urgent response to countries with acute ARV stock out supply situation. Functional links created for this purpose should allow the execution of various activities in the agreed terms, while avoiding the use of many intermediaries WAHO will be responsible for all purchases of the buffer stock and ensure the following: - The procurement of all products purchased under this process will be in accordance with the procurement procedures at WAHO; - The granting of exemption for clearance of goods. where necessary; - The contracting of the collaborating Central Medical Store and suppliers; - Logistical support to the collaborating Central Medical Store - The delivery of the stock at the collaborating Central Medical Store ; - The logistics coordination of ARV buffer stocks in ECOWAS countries; - The management of an early warning system; - The monitoring, evaluation and control of the management of the buffer stock; 1.7. The collaborating Central Medical Store will undertake the following activities: - The receipt of goods in accordance with procedures specified in the relevant section of the SOP; - The selection of quality control laboratory for testing and management of test results, - The logistics management of the buffer stock in the country; - The quality assurance of the product in accordance with the procedures specified in the relevant section of the SOP; - The preparation of stock in case of emergency and delivery to the recipient central medical store in accordance with the procedures specified in the relevant section of the SOP. He will contract a shipping company to handle the stocks shipping procedures to the recipient central medical store.

15 Page 15 of The country focal points will ensure the following: - The reporting of data on ARV stock management. - The requests for ARVs in emergencies through the National AIDs Control Programme; - The management of the importation and customs clearance process in their country The National Drug Regulatory Authorities (NDRA) of the host country will undertake the following activities - The responsibility for quality assurance of medicines and compliance with regulatory requirements for import and export of medicines within the ECOWAS countries - The conduct GMP and good storage practices inspections at the supplier s sites and collaborating Central Medical store WAHO will ensure the upgrading of the warehouses of the collaborating Central Medical Store to the required standard before stocking The diagram in Figure 1 (Appendix 1) summarizes the steps in the management and coordination process. 2. Operation of the information Management system The coordination mechanism defined in the context of ARV stock security constitutes a framework between the Central medical stores and national AIDS control Programs, WAHO, JURTA PSM and other donors involved in the management of HIV / AIDS. It describes how national AIDS control Programs, Central medical stores in ECOWAS countries and WAHO work together in this process. It is intended to: - Lend credibility to the vision of WAHO; - Create a true synergy between the different actors; - Speak with one voice; - Optimize inventory management and resources 2.2. After the signing of the contract between WAHO and collaborating central medical store, procurement will be initiated by WAHO for all products of the buffer stock and supply plan will be developed The receipt, storage, quality assurance and logistics management of drugs will be conducted by the collaborating central medical store WAHO will work in collaboration with National AIDS Control Programs and Central medical stores of ECOWAS countries to improve communication and information sharing between all stakeholders, both horizontally and vertically. The web based information system will increase visibility of information through a Procurement Planning and Monitoring Report (PPMR) and ARV Interchange web based system. The PPMR is a monthly report that describes national stock status of ARVs. It includes commodity security updates and stock status data. By providing visibility into information about national ARV supply chains, it supports planning, coordination, and

16 Page 16 of 54 strategic allocation of resources. The ARV Interchange is a website that helps coordinate ARV orders and shipments by gathering and storing data from the central procurement offices of major ARV donors and governments, and provides access to timely information that can be used for pipeline monitoring, commodity management, and planning. These two tools help improve visibility of information among global and national partners. As actors become more willing to share their information and increase data visibility, it builds trust among partners; with greater trust comes even more comfort in sharing information. Subsequently, donors and governments are able to make better informed decisions about timing and quantities of shipments, responses to emergency orders, and allocation of resources There will be a system of sharing information through a web based computerized platform developed by WAHO. The Information system would allow the focal points of National AIDS Control Programs, to transmit the digital data on stocks for first line treatment in countries, thereby facilitating the management of the regional buffer stock. The implementation of the web-based software is designed to improve the availability of ARVs at the country level, provide real time information on the status of stocks of ARVs and promote transparency and accountability. Data on stocks of first line treatment ARVs will be entered monthly in the web-based software. This will create a registry on the availability of stocks of ARVs and allow easy access to information. This software will allow access: - To more accurate estimates of stock and status of availability of first line treatment ARVs at the country level. - To a monitoring system which is more sensitive to detect risk of stock out through an early warning system. - To an integrated information system that can serve as an example for other programs. Each country can join freely and access the monthly reports on first line ARVs. The country focal points will be trained in the use of this software and each will receive a specific Web access code specific to the software to provide details of their stock of ARVs. Items to be entered include: - Country; - date of submission of data; - The stock level indicators for each of the first line ARVs (in months stock) minimum stock, maximum stock, buffer stock, average monthly consumption, countries threshold alert level of ARV stock defined according to the number of patients ; - The status of each first-line ARV stock: quantity, number of months available stock, stock status (above or below the alert threshold or the minimum stock) expiration date ; - Expected delivery Date and supply of pipeline stock; - Recommended actions. The country focal points would update the status of their first line ARV drugs not later than the fifth of each month.

17 Page 17 of 54 WAHO Program Officer for medicines and vaccines is designated to centrally manage the information system. He receives monthly reports through this web-based software and conducts analysis and interpretation to aid in decision-making. Risks of stock outs identified are subject to the decision of the Director general of WAHO. This reduces the processing time and improves visibility of the country needs. It is possible for different donors, to access country-specific data if they so wish Annual coordination meetings of stakeholders will be organized under the auspices of WAHO. These meetings will allow exchange of views on specific issues related to the management of the buffer stock. The collaborating Central medical store will present during these meetings, its activities, the status of the buffer stock, the difficulties associated with the management of this stock and proposed solutions. These annual meetings will also afford the opportunity to improve coordination and management of the Buffer stock and validate the relevant annual work program of the Regional Coordination Unit and the management unit of the Buffer stock host country WAHO will ensure that an agreement is signed between the customs authorities of different countries in order to facilitate the quick transfer of ARVs from the collaborating central medical store to the other central medical stores of ECOWAS countries.

18 Page 18 of Standard Operating Procedure for Reporting, Forecasting and Quantification Number of Pages: 2 Serial number: ARV-SS 02/1.0 Prepared by: Name: Reviewed by: Name: Title: Title: Sign: Sign: Date: Date: OBJECTIVE: To describe the procedures for reporting, forecasting and quantifying antiretroviral (ARV) drug requirements for the Regional buffer stock. RESPONSIBILITY: Central Medical Stores in ECOWAS countries WAHO RESOURCES: Forecasting Spreadsheet Inventory tracking form at the collaborator Central Medical stores PROCEDURE: 1. Data reporting and validation 1.1. The Central Medical Stores in ECOWAS countries will submit to WAHO Program Officer for HV/AIDs, morbidity data by 31 st December of each year and consumption data every month. The morbidity data shall comprise the total number of Adult clients on first line Antiretroviral Therapy (ART), yearly target for first line ART, number or % of Adult clients on the various options of first line Antiretroviral Therapy. The consumption data shall comprise logistics information for each of the Antiretroviral medicines used by first line ART clients. The details of data to be provided are shown in Appendix 2 and The WAHO Program Officer for HV/AIDs collates the NACP-specific consumption and stock balance data for each country in addition to receipt and distribution activity at the collaborator Central Medical Store Warehouse into one report a) The report should include drugs from all sources (i.e. WAHO procured, donations, government-provided, etc.) b) The National AIDs Control program manager should be notified of any high or low levels of stock that could lead to expiries or stock-outs, respectively WAHO to review each monthly report for the following: a) Sufficient stock in the pipeline at the national level b) Accuracy in reporting last receipts to enhance accountability. This should match the distribution plan c) Discrepancies between the previous month s closing balance and the opening balance of the current month

19 Page 19 of 54 d) Sufficient stock in the pipeline at the warehouse level (three-month supply) e) Slow moving stocks and advice on how to manage to avoid expiries f) Extremely high levels of stock that could lead to potential expiries 2. Forecasting and Quantification of products 2.1. WAHO collects/generates information on products selected, proportion of distribution in use for each drug, number of patients on each drug 2.2. ARV drug forecasts will be based on estimates of the number of patients to be enrolled on treatment and the number of patients to be maintained on treatment in the given budget period or year Upon discussion with the collaborating Central Medical Store, WAHO determines the appropriate quantities to be ordered per each procurement cycle, taking into consideration manufacturer lead times and country storage capacity. Consideration shall also be given to the possible pipeline stocks of drugs from one cycle to the next WAHO shall integrate the stock movement information with patient and treatment information to forecast and quantify drug requirements for a defined period of time not less than 12 months on a rolling basis. A supply plan is then prepared for the requirements and shared among the participating countries. This activity is done annually at the Annual coordination meetings of stakeholders to make it all inclusive so that all country teams are also represented This drug quantification report is sent to the Director-General of WAHO for review and approval Quantification information will be shared as follows: a) National Stakeholders involved in HIV/AIDs prevention and treatment b) National AIDs/STI Control Programmes for coordination and Harmonization of HIV/AIDS c) The WAHO management team in each country for planning purposes d) Procurement agents/suppliers and manufacturers

20 Page 20 of Standard Operating Procedure for Procurement process managementplacement of drug orders Number of Pages: 3 Serial number: ARV-SS 03/1.0 Prepared by: Name: Approved by: Name: Title: Title: Sign: Sign: Date: Date: OBJECTIVE: To describe the procedure for placement of drug orders from manufacturers to collaborating Central Medical Store. RESPONSIBILITY: Director general of WAHO WAHO procurement office/ Procurement agent WAHO Finance Department WAHO Program Officer for HIV/AIDs RESOURCES: List of first treatment ARVs included in the buffer stock; Specifications Call for expressions of interest; Information on products ; Information on manufacturing site; Evaluation reports; Reports of inspection of manufacturing sites; Contract between the supplier and WAHO; Purchase Order (PO) Logistics Management Information System (LMIS) Procurement Planning and Monitoring Report (PPMR) and ARV Interchange web based system PROCEDURE: 1. Development of the specifications of list for products 1.1. The list of products for the buffer stock will be mainly those recommended at the international level and at the different countries of ECOWAS in the first-line treatment of HIV / AIDS WAHO, in collaboration with the collaborating Central Medical Store will develop the terms of reference taking into account the specific technical and administrative requirements (product specifications, requirements for the site manufacturing etc) as well as WAHO requirements for the procurement of Health Products.

21 Page 21 of The specifications will be detailed, clear and unambiguous and should specify at least the following: o the name of the active ingredient (s); o reference pharmacopoeia; o the strength o the dosage form; o the route of administration; o the size of the package; o the packing material; o Labelling requirement. 2. Call for expressions of interest 2.1. The Director General of WAHO will issue a call for expressions of interest to enable suppliers to submit proposals in respect of goods specified in the call This call for expressions of interest will normally be published on the website of WAHO and possibly through other media outlets, such as the international press Calls for expressions of interest will be open to manufacturers of finished pharmaceutical products in ECOWAS region Expressions of interest must be sent to WAHO within the time specified in the call for expressions of interest. A receipt number and / or a registration number will be assigned to each expression of interest received The applicant must send the following documents to WAHO as part of the expression of interest: - A letter that expresses interest and confirm that the information provided in the application is complete and in proper form; - The product dossier in the format specified in the Standard Tender documents relating to the presentation of the product data and information; - Product samples to allow visual examination, chemical and pharmacological analysis; - A site dossier for each manufacturing site listed in the product folder, in the format required specified in the WHO guidance on the submission of a dossier of establishment. 3. Pre-qualification of suppliers 3.1. WAHO should undertake a comprehensive evaluation of the quality of ARV products, based on information provided by the manufacturers of those products and following the inspection of corresponding manufacturing facilities Upon the filing of appropriate folders, WAHO in collaboration with the NDRA of the buffer stock host-country, will carry out the following activities: - Assessment of product dossiers, which should include data and information on the products as specified in the Standard Tender documents. - Inspection of manufacturing sites of finished products which must comply with GMP

22 Page 22 of The information on the products presented in the dossier submitted during preselection will be sent to a team in charge of product evaluation. The team will evaluate all aspects of the dossier, request additional information if necessary, and will issue its recommendations on the proposed product. This team will include: a representative of WAHO to lead the team, the person in charge of registration of health products in the NDRA of the buffer stock host-country and the person in charge of the selection of suppliers of collaborating central medical store The information on the manufacturing site will be sent to a team in charge of inspection which will conduct a site inspection, request for corrective and preventive measures where appropriate, and decide on compliance with GMP by the manufacturing sites. The inspection team include: a qualified inspector representing the WAHO to lead the team and an inspector appointed by the NDRA of the buffer stock host-country. An inspector from the NDRA of the country where the manufacturing site is located must be chosen as an observer The site inspection will not be applicable if the manufacturer is WHO prequalified and provides all the necessary documentation on compliance with GMP The two teams will work collectively on the outcome of their work and submit recommendations on the pre-qualification to WAHO for the establishment of the list of selected products and suppliers If the evaluation shows that a product and its corresponding manufacturing site meet the standards recommended by the WHO, this product will be added to the list of pharmaceuticals that are considered acceptable and in principle, can be procured by WAHO Pre-qualified suppliers would be invited to register the corresponding products at the NDRA of the buffer stock host-country. Registration arrangements for these products will be a contract between WAHO and NDRA of the buffer stock hostcountry. 4. Procurement of the products 4.1. Procurement shall be conducted in accordance with ECOWAS Tender Code and Procedures, with pre-qualified suppliers.

23 Page 23 of Standard Operating Procedure for receiving and storage of drugs of the regional buffer stock Number of Pages: 5 Serial number: ARV-SS 04/1.0 Prepared by: Name: Approved by: Name: Title: Title: Sign: Sign: Date: Date: OBJECTIVE: To assist both the flow and reliability of supplies from source to user as economically and reliably as possible, and without significant wastage, loss of quality, or theft. ARVs purchased, will be received and stored so that their quality and integrity are maintained, that batch traceability is in place and that stock rotation is possible. RESPONSIBILITY: WAHO Program Officer for HIV/AIDs Collaborating Central Medical Store Manufacturer Manufacturer s shipping agent RESOURCES: Airway Bill Packing List Goods Received Report/Stores Receipt Voucher Goods Received Discrepancy Report Shipment Discrepancy Report Delivery Note Product Index; Certificate of quality control; Certificate of pre-shipment control; ARVs Management Software of collaborator central medical store. PROCEDURE: 1. Receipt of products 1.1. Four weeks prior to the delivery of the products, the supplier will send to the collaborating central medical store, and the WAHO program officer of HIV / AIDS, a notice of delivery of goods and copies of the air waybill, packing list and other documents required by the regulatory body such as certificates of quality control of each batch of product If the shipping documents are not ready four weeks prior to shipment, the supplier shall inform the parties mentioned above of the intended date for delivery of products. The different regulatory and quality assurance documents will be provided

24 Page 24 of 54 as soon as possible with specific shipping dates for final confirmation. These shipping documents and confirmation must be received by the collaborator central medical store collaborator at least two weeks in advance to ensure that all local regulations and customs process will be completed on time The supplier shall transport the ARVs in good conditions to the port of entry of the buffer stock host-country. Twenty-four hours in advance, the supplier shall notify the collaborator central medical store of the imminent arrival of products in order for arrangements to be made for the receipt of goods On arrival of goods in the buffer-stock host-country, the shipping agent of the supplier and shipping agent of the collaborator central medical store will perform the customs formalities following regulations of the country The stock is then transferred to the premises of the collaborating central medical store in accordance with the required transport conditions The manager of the collaborating central medical store is notified by the shipping agent of the arrival of the products in the premises of the collaborating central medical store The person in charge of the management of ARVs in the collaborating central medical store goes to the receiving store and shall, with the receiving team of the central medical store, receive the products in the following steps : Verification of the presence of accompanying documents: - Waybill - Packaging list - Certificate of quality control of each batch of products delivered - Certificate of pre-shipment control In addition to the above, the team will check for discrepancies between the order, the delivery bill and the supplier labels: verify that quantity and technical specifications fully conforms to that spelt out in the contract. In addition, the compliance with product labelling will be assessed as well as the minimum shelf life of at least 2/3 of their useful life of the product. The integrity of packages, seals of cargo and uniformity of containers will be checked. If more than one batch of products are delivered, it will be subdivided in accordance with the batch numbers of the supplier, and then inspection of each container carefully conducted to ensure it was not contaminated, tampered with or damaged and any container suspected to be substandard or incomplete, will be isolated Notification in writing for any problem identified shall be made in the presence of the freight forwarder of the supplier. Products close to their expiry date will not be accepted Any damage of the container and any other problem related to quality of the product will be subject to an investigation and the WAHO program officer of HIV /

25 Page 25 of 54 AIDS will be notified of this fact. Medicines under quality assurance investigation will be the responsibility of the supplier and should not be distributed for use If delivery is compliant, products are validated provisionally subject to the independent quality control laboratory. The form of quarantine reception is completed and the provisional acceptance report written. A copy of the report is addressed to the WAHO Program Officer accompanied by copies of all supporting documents and a copy of the quarantine reception certificate. The problems identified are reported in the report of receipt In order to collect samples for testing, a random sampling is performed according to the procedures in force at the collaborating central medical store for an independent laboratory control After sampling, the products are placed in quarantine under the conditions of storage of ARVs. The isolation of batches is maintained during quarantine and throughout the storage period. Products remain in quarantine until authorization (results of independent quality control found to comply with the product specifications), which allows release for use. In this case, complete a stores receipt voucher. Take ARVs on ledger charge and complete operation in the ARVs management software of the central medical store by including all required information on the products and the supplier At each stage of quality control, a report is sent to the Director General of WAHO with relevant documents: Copies of certificates of analysis, copies of stores receipt voucher, copies of certificates of analysis In the case of rejection, a letter of notification of rejection is sent to the Director General of WAHO with copies of test results Strict precautions must be taken to prevent rejected drugs being used. Rejected drugs must be clearly demarcated and stored in a locked room accessible only to authorized personnel, waiting to be destroyed or returned to suppliers The Director General of WAHO has a period of one month from the receipt of the letter of notification to decide what action to take for the products concerned. At the end of this period, the products are destroyed according to the procedures of the collaborating central medical store and a copy of the minutes of destruction is sent to the Director General of WAHO On complete verification of the received goods, the distributor records the quantity of each product received, batch number and expiry date on a goods received note or stores receipt voucher which is subsequently signed Once drugs are certified as received, property of the goods passes to WAHO. However, safe custody risk passes to the warehousing and distribution agent The collaborating Central Medical Stores sends a copy of the signed goods received report/stores receipt voucher to the WAHO Program Officer for HIV/AIDs.

26 Page 26 of 54 As this document is required for supplier payment, it should be forwarded to the WAHO Program Officer for HIV/AIDs as soon as possible after receipt of goods On receipt of this report and a supplier invoice, the WAHO Program Officer for HIV/AIDs in conjunction with the program and finance departments will process payment to the supplier for the delivered products, less any amount due to discrepancies in the delivery, if applicable If the order is completed by the delivery, the purchase order (PO) is closed on final payment. If any portion of the order remains outstanding, the PO will remain open until full delivery is made and payments made. 2. Shipment discrepancy reportage 2.1. Errors in shipment must be recorded on the Shipment Discrepancy Report. Errors in shipping may include the following: - Damaged products, including: o Broken tablets o Drugs that arrive past their expiration date o Items that have no labels o Refrigerated items that arrive at room temperature or are warm o Inappropriate storage procedure during transportation of refrigerated items - Requirements from the tender that have not been met - Items listed on the invoice/delivery note that are missing from the Shipment - Items received that were not ordered or were not listed on the invoice/delivery note 2.2. The Shipment Discrepancy Report should be writing by the receiving officer and should be witnessed by another staff member Shipment Discrepancy Report will include: - Date of shipment - Name of receiving officer - Name of witnessing pharmacy staff member - Invoice Number - Number of boxes received - Number of other containers received: describe the type received, e.g., drum - For each item that is damaged, missing, or incorrect, fill out: o Serial No.: where the product is recorded (if you are reporting items missing from the shipment, this will be left blank) o Item Description : Generic drug name, Strength/concentration, Dosage form o Code No.: number which is specific to each drug, strength/concentration, and dosage form o Unit: unit of issue (i.e., number of tablets per package) o Quantity Broken, Quantity Missing, Quantity in Error: items Broken/missing/issued in error

27 Page 27 of 54 o Comments: describing nature of error (i.e., broken bottles, expiration date for drugs delivered expired, missing drugs, or drugs received that were not ordered or not listed on invoice, etc.) Signatures and names of receiving officer and witnessing pharmacy staff member The original copy of the Shipment Discrepancy Report is sent to the WAHO Programme manager for HIV/AIDS for action and one copy is kept on file with the Counter Receipt Voucher. 3. Storage of ARV drugs 3.1. The buffer stock shall be stored upon receipt into an air-conditioned zone (18-25 C) in accordance with the SOP for the storage of ARVs at the collaborating central medical store (storage mode, location, arrangement) Compliant products are recorded in the corresponding management tools of the collaborating central medical store (ledger, stock cards,) with batch numbers and expiry dates There is no physical separation between the ARVs of the regional buffer stock and those from other donors The cartons are packed so that the arrows point upwards and that identification labels, expiry dates and manufacturing dates are clearly visible Store pharmaceutical products in order to facilitate the principle of "first expired, first out" (FEFO) and inventory management Monitoring of storage conditions (temperature control,...) shall be performed according to the operating procedures of the central medical store and all monitoring records are retained for at least one year after the end of the shelf life of stored product or as long as required by national legislation The cases of defective air conditioning system and corrective actions carried out should be a report that will be archived. This report and monthly reports on storage conditions must be made available to consult by WAHO whenever needed Separate damaged or expired products, removing them from the stock in the month N-1 of their expiration and destroy in accordance with central medical stores SOP.

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