JEV MPID 4.docx

DATE: 30 JANUARY 2020

MPID #4

NSN: 6505-01-607-7018

ITEM IDENTIFICATION: JAPANESE ENCEPHALITIS VIRUS VACCINE, Purified, Inactivated, Single-Dose Prefilled Syringe

SALIENT CHARACTERISTICS

Shall be Japanese Encephalitis Virus Vaccine, Purified, Inactivated.

Shall be FDA-approved for active immunization against Japanese Encephalitis disease.

Shall be FDA-approved for administration to persons 2 months of age and up.

Shall be Vero Cell culture derived.

Shall be a sterile suspension.

Shall not contain any stabilizers.

Shall be Thimerosal/Preservative-free and Latex free.

Shall be suitable for intramuscular administration.

Shall be supplied as a sterile 0.5 ml suspension in a pre-filled syringe (Type 1 glass) with a plunger stopper (chlorobutyl elastomer) with or without a separate needle. Children 2 months to <3 years of age receive 0.25 mL. Individuals 3 years of age and older receive 0.5 mL.

Shall have an expiration dating period of 24 months. Not less than 21 months of the expiration dating period shall remain at time of delivery to the Government.

Material shall be shipped under constant refrigeration: 2° - 8° C (35° - 46° F). No excursions permitted.

Do Not Freeze. Protect from light.

Unit. Each. One each (syringe) containing a single-dose pre-filled syringe, as specified, constitutes one unit.

Medical Marking Standard 1C MMS1C dated 02 November 2017 shall apply to all acquisitions issued by the Medical Supply Chain.

REGULATORY REQUIREMENTS.

Federal Food, Drug, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/ contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.

Recovered Materials. The offeror/contractor is encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.403 to the maximum extent practical.

QUALITY ASSURANCE PROVISIONS.

Contractor Certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Medical Procurement Item Description, and that the product conforms to the producers' own drawings, specifications, standards, and quality assurance practices, and is the same product offered for sale in the commercial market-place. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.

Responsibility for Inspection. The contractor is responsible for the performance of all inspection requirements as specified herein. The contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.

Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.

Examination and Testing. Examination and testing shall be conducted on the product in accordance with commercial practice. The sampling for examination and testing shall be in accordance with commercial practice.

Disposition. The contractor shall provide the Government with either product stability information to be used as part of the Government's disposition decision, or provide a point of contact who will review each excursion forwarded to them by the Government, and provide the Government disposition. Disposition will then be provided to the end customer by the Government."

PREPARATION FOR DELIVERY

Packaging and packing.

Packaging and packing shall be commercial, as specified herein. Material shall be packaged and packed in accordance with ASTM D 3951 (Standard Practice for Commercial Packaging).

Perishable medical material. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208. Perishable items requiring constant refrigeration shall be properly packaged and marked in accordance with cold chain management protocols in addition to all applicable regulatory requirements and markings specified in MMS1C.

In order to monitor the temperature ranges during transit, the contractor is required to place one DLA-compatible temperature monitor (that shall be pre-approved by the government) into five randomly chosen boxes for each full truck–load shipment to each requested destination (two monitors will be required for less than a full truck-load). The contractor shall place an “X” or some other identfying mark on the boxes containing the monitors to alert the receiving depot to their location. When small parcel carriers are used (e.g. FedEx) one temperature monitor per box will be required. Any shipment of any size that is delivered to the Government without temperature monitors will be rejected and returned to the contractor at contractor’s expense or disposed of at the direction of the contractor.

Material shall be unitized in accordance with MMS1C.

Packaging and packing quantities. Quantities of units to be supplied in the intermediate package (if supplied) and exterior (shipping) container shall be in accordance with commercial practice.

Labeling and marking.

Each unit (EACH) shall be marked in accordance with commercial practice. Marking shall include the lot (control) number, expiration date and the legends "STORE BETWEEN 2o - 8o C (36o - 46o F)" and "DO NOT PERMIT TO FREEZE" or similar commercial legends.

Any intermediate package, exterior (shipping) container, and unitized load shall be marked as specified in *Medical Marking Standard No. 1C*.

Intermediate package. Commercial markings on the container are acceptable, provided they do not interfere with placement of required Government markings. The following markings shall be supplied on each intermediate package, as well as any additional markings as specified in MMS1C and or contract/purchase order.

a. Bar code.

NSN

b. Identification data

NSN

CAGE code and manufacturer’s product/part number Item identification Government quantity and unit of issue (total number of units of issue in the intermediate package) Contract/purchase order number Type and date of unit preservation (either Military method or "COMM'L" and date preserved, as applicable) Lot control number/expiration date and storage legends ("STORE BETWEEN 2o - 8o C (36o - 46o F)" and "DO NOT PERMIT TO FREEZE") or similar commercial legends.

Exterior (shipping) container. The following markings shall be supplied on the side of the exterior (shipping) container having the largest marking surface, as well as any additional markings as specified in MMS1C and or contract/purchase order.

a. Identification data.

NSN

CAGE code and manufacturer’s product/part number Government quantity and unit of issue (total number of units of issue in exterior (shipping) container) Type and date of unit preservation (either Military method or "COMM'L", as applicable, and date preserved) Gross weight Contract/purchase order number Lot control number/expiration date and storage legends ("STORE BETWEEN 2o - 8o C (36o - 46o F)" and "DO NOT PERMIT TO FREEZE") or similar commercial legends.

b. Bar codes.

NSN

Contract/purchase order number CAGE code

c. Destination address label. A destination address label shall be supplied on each exterior (shipping) container. A bar-coded military shipping label shall be required for OCONUS shipments moving through the DTS and when required in the contract/purchase order and/or SOW. Unless otherwise specified in the contract/purchase order, the contractor/vendor may supply a commercial address label on each exterior (shipping) container and/or unitized load for CONUS/OCONUS shipments moving through commercial channels. NOTE: When unitization is required, the applicable destination address label need only be supplied on the unitized load.

Unitized load. The following markings shall be supplied on one side of the unitized load, as well as any additional markings as specified in MMS1C and or the contract/purchase order.

a. Identification data.

NSN

CAGE code and Manufacturer’s part number Government quantity and unit of issue (total number of units of issue in unitized load) Type and date of unit preservation (either Military method and date preserved or “COMM’L” and date preserved, as applicable) Weight (total weight of load, including pallet) Contract/purchase order number Lot (control) number and expiration date and the legends: "STORE BETWEEN 2o - 8o C (36o - 46o F)" and "DO NOT PERMIT TO FREEZE" or similar commercial legends.

b. Bar codes.

NSN

Contract/purchase order number CAGE code

c. Destination address label. A destination address label shall be supplied on each unitized load. A bar-coded military shipping label shall be required for OCONUS shipments moving through the DTS, and when specified in the contract/purchase order and/or SOW. Unless otherwise specified in the contract/purchase order, the contractor/vendor may supply a commercial address label on each exterior (shipping) container and/or unitized load for CONUS/OCONUS shipments moving through commercial channels.

Example (see MMS1C page 31-33 figure 4,5,7, 8 and page 36 figure 13.

NOTES.

The following documents are available from the following link:

1. Medical Marking Standard No. 1C.

https://www.dla.mil/LandandMaritime/Offers/Services/TechnicalSupport/Logistics/Packaging/MedicalPack1.aspx