Annex. 4 PRODUCT SPECIFICATIONS AND TECHNICAL REQUIREMENTS

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1 Annex. 4 PRODUCT SPECIFICATIONS AND TECHNICAL REQUIREMENTS THIS DOCUMENT IS TO PROVIDE THE OFFERORS WITH THE PRODUCT(S) SPECIFICATIONS AND TECHNICAL REQUIREMENTS FOR THE PROCUREMENT OF COMMODITIES LISTED IN THE RFQ: GHSC-PSM-TO UA-LAB Item # I. Product Specifications Product Category Description Quantity Blood Collection Tube, K2-EDTA, 4 ml, Plastic, White Top, 100 Tubes 689 Needle, Multi-Sample, Blood Collection, 21G, 1.5 in, 1000 Each 130 Blood Collection Tube Holder, One-Use, Non-Stackable, 1000 Each 130 Sample Tube, 4.5 ml, Polypropylene, Round Bottom, Screw Cap, Sterile, 1000 Each 65 Pipette Tips, ul, Aerosol Barrier, Sterile, Clear, for Pipetman P-200, 10 Racks of 96 Tips 255 Pipette Tips, 1000 ul, Universal Fit, Sterile, RNase/DNase/DNA/Pyrogen Free, 100 Tips 40 Blood Collection Tube, K3-EDTA, 3 ml, Plastic, Lavender Top, 1000 each 61 Pipette Tips, 1000 ul, Universal, Maximum Recovery, Sterile, 100 Tip 11 II. See Table above III. Page 1 of 5 Quantity Conformity with Quality and Products Standards Offerors and the products presented and delivered must fully comply with the following eligibility requirements: 1. Manufacturer shall conform to the quality standards set by the International Organization for Standardization and/or the US FDA Quality System Regulations. Manufacturer must be quality assured with certifications like ISO 9001:2000 (or above) or ISO or approved by standards regulatory bodies in country of manufacturer, which bodies must be accredited by or affiliated to standards institutes like ISO, with copy of

2 certifications(s) included. A copy of the manufacturer(s) certifications(s) must be provided. 2. Product Quality Standards by Product Type: : Must have a US FDA Clearance (510k) or CE Mark (SRA*). A certificate of conformance shall be provided for each lot procured : A certificate of conformance/analysis shall be provided for each sterile lot procured. Products for use in molecular applications (RNAse/DNAse/Pyrogen free) shall have a certificate of conformance/analysis for each lot procured. *USAID recognized stringent regulatory authorities (SRA): U.S. Food and Drug administration (USFDA), Japanese Ministry of Health, Labor, and Welfare (MHLW), also represented by the Pharmaceuticals and Medical Devices Agency (PMDA); European Medicines Agency (EMA) and member states admitted to the European Union (EU) prior to 1996 Hague Convention (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and United Kingdom); SwissMedic; Health Canada; and Australia Therapeutic Goods Administration (TGA). IV. Quality Assurance Provision V. According to GHSC-PSM Standard General Contract Terms and Conditions in Annex 1.Pre-Acceptance Sampling and Testing requirements When applicable, offeror shall coordinate with GHSC s quality assurance contractor, Global Health Supply Chain Program - Quality Assurance (GHSC-QA) implemented by FHI360, who will implement inspection, sampling, quality assurance testing and acceptance within the terms and conditions outlined below. GHSC-QA reserves the right to sample from the Manufacturer s facility and to perform or cause to be performed any of the tests and inspections set forth in this purchase description to assure that supplies and services conform to the prescribed requirements. VI. Sampling requirements VII. Test method VIII. Compilation of laboratory testing data Page 2 of 5

3 IX. Lot disposition X. Frequency monitoring XI. Manufacturer Furnished inspection data XII. GHSC QA will require that the Manufacturer provide a summary of the final inspection results for each lot available for delivery under this contract prior to shipment to GHSC-PSM. Individual test reports shall be maintained by the Manufacturers, and shall be made available for inspection by GHSC-QA.Post-Acceptance inspection Unless otherwise specified in the Subcontract, each product lot delivered to GHSC-PSM shall comply with all product specifications and test procedures in effect at the time of subcontract award. GHSC-QA reserves the right to sample from and perform or cause to be performed any of the tests and inspections set forth in this purchase description to assure that supplies and services continue to conform to the prescribed requirements after product acceptance. In the event, products are determined to not be fully compliant, the Offeror shall be required to remedy any defects or faults XIII. Product documentation a. Evidentiary documentation of Manufacturer QMS certification by internationally recognized standardization body b. c. Product information data sheet b. Manufacturer s product reference and description c. Manufacturer s contact details, including link to website d. Recommended storage and transportation conditions e. Commercial brochure f. When applicable, country product registration or import permit to the country of destination. A certificate of analysis/conformance for each lot shall be provided XIV. Shelf life Items should be delivered with the maximum possible shelf life, with a minimum remaining shelf life upon delivery of 85%. XV. Shipping specifications Please provide estimated weight, dimensions and number of pieces. Page 3 of 5

4 XVI. Packaging and Packing Packing must be sufficient to ensure safe arrival to destination. Protective material must fully cover such hazards as extreme temperatures, exposure to weather, and open storage. All vehicles should be properly prepared for export, to withstand exposer to elements and rough handling during air, sea or inland transportation. The packaging shall provide full integrity of the Goods while shipment. Must be packed on Euro Pallets, shrink-wrapped, strengthened by angles, etc. Shipping boxes labels must reflect shipping temperature (labels, by colored adhesive tape, etc.) Outer Labeling: The label for IVD's must state the following information, except in cases where it is not applicable. In addition, all information must appear on the outside container or wrapper, or be easily legible through the outside container or wrapper. Such as the established/registered name, the intended use, a statement of warnings or precautions, the name and place of the manufacturer/distributor, the catalogue/lot/po or control number traceable to the production history, storage instructions adequate to protect the stability of the product, (i.e., storage/shipping temperature range, humidity, etc.), the consignee Address, and the manufacturing and expiration date. No weekends and Holidays arrivals. Temperature Sensitive Goods shall be accompanied with temperature loggers. Temperature Sensitive Goods shall be delivered in containers certified to 96 hours. Must provide shipping and storage temperature range of Goods. Please make sure documents are signed and stamped. All data must match on all export documents (quantity, weight, name of merchandise, addresses, batch #). Name of the Merchandise shall comply with indicated/established on Specifications to the Contract and valid Registration Certificate upon Technical regulations of Ukraine (if registered). Customs code shall comply with customs code used for import legalization (should be preliminary approved. Humanitarian Aid Goods pre-shipment legalizations, permits shall be obtained in Ministry of Social Policy of Ukraine. Process takes up to 6 weeks. One set of approved original commercial documents must be couriered to the consignee address once PSM gives green light - One set of approved original commercial documents must be given to the freight forwarder to be transported with the shipment at the time of pick up XVII. USAID Marking requirements (Not applicable) Chemonics reserves the right to require USAID marking as below: The Manufacturer (s) will be responsible for ensuring that all export shipping cartons, whether shipped from the United States or from any other source country, carry the official USAID emblem. Emblems will be affixed by metal plate, decal, stencil, label, tag, or other means, depending upon the type of commodity or export shipping carton and the nature of the surface to be marked. The emblem on each export-shipping carton will be affixed in a manner which assures that the emblem will remain legible until the carton reaches the consignee. The size of an emblem will vary depending upon the size of the commodity and the size of the Page 4 of 5

5 package or export-shipping carton. The emblem will, in every case, be large enough to be clearly visible at a reasonable distance. Emblems will conform in design and color to samples available from USAID and can be found at: Emblems will be obtained by the Manufacturer(s) at its expense in the quantity and type required. The Manufacturer(s) will be required to affix USAID emblems in accordance with the marking requirements stated above. A list of the emblem suppliers can be found at: XVIII. Innovation a. Bar coding b. EDI (Electronic Data Interchange) c. Vendor Management Inventory Page 5 of 5