The following tools has been used for assessing the capacity and quality of storage of Central Medical Stores (CMS) and is based on MQAS (Model Quality Assurance System) of WHO and WAHO technical document for the buffer-stock of antiretroviral drugs in ECOWAS countries. The Appraisal criteria are:
0: System / procedure does not exist
1: Very low level of compliance or implementation 2: low level of compliance or implementation 3: Medium level of compliance or implementation 4: Good level of compliance or implementation
5: Implementation comprehensive and coherent, consistent with the expectations of MQAS
NB: The multiplication factors 2, 3, 4 or 5 are used for the scoring to 10, 15.20 or 25 points Elements of appraisal Quotation RCI Nigeria Ghana BFA
1. Political aspects 30 30 15 30 30
1.1. Will of the health authorities and the
management of the CMS to host this regional buffer stock
15 15 15 15 15
1.2. Facilitation of the health authorities to sign an agreement with the Customs
Administration for shipments
15 15 0 15 15
2. Management/Organization 15 7 2 5 13
2.1. Existence of a detailed flow chart indicating the positions and reporting relationships
5 3 1 4 4
2.2. Existence of a written job description defining the responsibilities of all staff
5 4 1 1 4
2.3. Presence of an insurance for warehouses 5 0 0 0 5
3. Compliance with NDRA requirement 20 14 13 16 14
3.1. The CMS is authorized to perform
distribution activities (eg, pharmaceuticals) in accordance with national legislation.
5 4 1 4 4
3.2. The importation of drugs is exclusively at designated entry ports by the competent authorities
5 3 3 3 3
3.3. The CMS import pharmaceutical products according to NMRA requirements
(registration, special authorization)
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65 3.4. Does the CMS take import licenses at the
NMRA
5 4 4 4 4
4. Human Resources 10 3 2 3 3
4.1. Adequate number of staff and trained for the activities of the CMS
5 3 2 3 3
4.2. Existence of a plan of human resource development (including training plan)
5 0 0 0 0
5. Quality system 50 27 11 22 24
5.1. Existence of a quality assurance policy at the CMS
5 4 1 3 4
5.2. Existence of a mechanism for pre- qualification for the selection of couples suppliers / products
5 4 2 4 4
5.3. Certification/accreditation experiments of CMS
5 4 0 0 0
5.4. Existence of a quality manual and implementation of quality policy
5 3 0 0 2
5.5. Procedures defined are implemented and they cover all technical activities including pre-selection, purchasing, receiving, storage, distribution
5 4 1 4 4
5.6. There is sufficient office space and storage space for storage of products, documentation, samples, reports, records and other
documents.
5 1 1 4 3
5.7. Proper application and protection of systems. A backup of electronic records is done and maintained to prevent accidental data loss
5 2 1 2 2
5.8. Implementation of a procedure for handling complaints (review of complaints, risk assessment, identification of causes)
5 1 1 1 1
5.9. Implementation of a procedure for handling counterfeit and presumed counterfeit products
5 1 1 1 1
5.10. Conduct of internal audits or self-inspection 5 3 3 3 3
6. Documentation 25 18 5 15 16
6.1. A comprehensive documentation system exists: Quality policy, quality manual, organizational procedures, technical
procedures, guidelines, standards, records and documents related
5 3 1 3 3
6.2. The documents are designed, completed, revised, modified and distributed with care.
66 Documents are regularly reviewed and
updated. The replaced documents are removed from the circulation.
6.3. Existence of procedures or instructions regarding operations in the CMS that may affect product quality or distribution activities.
5 4 1 4 4
6.4. The keeping records (electronic or paper) ensure traceability throughout the supply chain.
5 3 1 3 3
6.5. Records for the receipt of the products contain at least the date, designation of product, batch numbers and expiry dates, the quantity received or supplied, and the name and address of the supplier.
5 4 2 3 3
7. Reception, storage and handling 20 14 7 14 15 7.1. SOP written and followed for the receipt,
sample storage and products handling
5 3 0 3 3
7.2. Sufficient space for the receiving and the shipping of products. Reception and shipping areas separated and protected against bad weather.
5 4 2 4 4
7.3. All products are received and verified in accordance with SOP and placed in quarantine until their release (for example, meeting the requirements of the book of specifications: folder preselected, order form, certificate of analysis, WHO certificate …)
5 3 1 3 4
7.4. Records of each delivery (product
description, quality, quantity, supplier, batch number from the supplier, date of receipt, batch number given and date of expiry).
5 4 4 4 4
8. Quality control 30 16 21 21 17
8.1. There is a system in place for quality control of products purchased.
5 3 3 3 3
8.2. Sampling plans that ensure that
representative samples are taken for analysis are detailed in written procedures and are based on risk assessment. The staff in charge of sampling is qualified and experienced.
5 3 3 3 4
8.3. Existence of a suitable quality control laboratory for testing products independently in accordance with the specifications and standards approved. The laboratory meets the
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67 general requirements for practices covering such facilities, policies and procedures, personnel, equipment, etc.
8.4. A SOP clearly describes the process and ensures that the products are not released for use until their quality has been satisfactory.
5 2 5 5 2
8.5. The results of quality control not meet specifications are treated in accordance with a procedure for investigation (cons-expertise).
5 3 3 3 3
8.6. Products not conforming to their
specifications are rejected by a procedure
5 3 3 3 3
9. Storage 75 40 40 54 50
9.1. Access to storage areas is controlled to ensure that no unauthorized person has access (24 hours a day, 7 days on 7).
5 4 2 4 3
9.2. Separate areas for the reception, storage and shipping
5 4 3 4 4
9.3. areas designated for rejected products and or recalled, expired product or with date close, suspected counterfeit
5 1 1 1 2
9.4. Products requiring cold chain are treated appropriately for transport, delivery, receipt and storage (cold rooms, refrigerators, coolers, ...). Generators are available in case of power failure.
5 3 2 3 3
9.5. All products are stored in protective
materials suitable, labeled, in proper storage conditions as specified on the label.
5 3 2 4 2
9.6. Storage areas have enough space (volume) and are sufficient in number
10 6 8 10 8
9.7. storage areas with adequate ventilation (aeration, air conditioning ...) and adequate lighting
10 2 8 8 8
9.8. System set up for recording the temperature in the storage areas. Monitoring records are retained for a suitable period of time
5 3 3 3 3
9.9. general protection of warehouses against thefts (windows, doors, ...) and pests (rodents, insects)
5 3 3 3 3
9.10. Existence of good storage practices 5 3 1 4 3 9.11. Storage and handling Equipment sufficient
number and appropriate
5 3 3 3 3
9.12. Presence of control equipment against fire (fire extinguishers, ...)
68 9.13. Means of transportation suitable for the
carriage of pharmaceuticals
5 3 2 3 4
10. Stock control 30 21 12 19 21
10.1. Stock rotation and control is ensured by the control of batch number and expiration date.
5 4 1 4 4
10.2. A periodic reconciliation of stocks is done (vs. actual stocks registered stocks). The major differences are studied and the results are documented in accordance with written instructions
5 3 1 3 3
10.3. Damaged containers are handled in accordance with written procedures. Any action taken is documented.
5 3 2 2 4
10.4. Regular checks are carried out according to a written procedure to identify expired
products.
5 4 2 4 4
10.5. The products covered by the recall are treated in accordance with a written procedure.
5 4 3 3 3
10.6. Returned products must be treated in accordance with a written procedure ensuring physical separation and proper storage conditions.
5 3 3 3 3
11. Logistical Management of Information System (LMIS)
35 22 10 24 23
11.1. Existence of a LMIS 5 3 1 4 3
11.2. Existence of a method for data collection 5 3 2 3 3 11.3. Existence of Good Practice on Information
Management
5 2 1 3 3
11.4. Good knowledge of management software features
5 3 1 4 3
11.5. Good definition of inventory levels 5 3 2 3 3 11.6. Existence of logistical support (supports of
keeping stock, shipping / transaction, consumption)
5 4 2 3 4
11.7. Existence of periodic reports 5 4 1 4 4
12. Appreciation of the ability to ensure a turnover of ARVs (own stock-buffer stock)
20 15 5 15 15
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69 13.1. Easy air connections with other countries of
ECOWAS (direct flights)
20 15 15 15 12
TOTAL 380 242 158 253 253