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Appendix C: Regulatory Aspects of Vaccine Development, Manufacture, and Distribution
Pages 164-169

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From page 164...
... in interstate and/or foreign commerce or to import the vaccine into the United States. To obtain a license, manufacturers must make a vaccine by an approved procedure, in approved facilities, and by an approved staff.
From page 165...
... Plants that follow current Good Manufacturing Practices must demonstrate complete control over product components, equipment, manufacturing environment, record-keeping, and personnel. There should be no changes in the facility or manufacturing process that could alter any critical aspects of the product between the time that pivotal lots for clinical trials are prepared to establish vaccine efficacy and the time that lots are prepared for final licensing and distribution (Weber, 1991~.
From page 166...
... In November 1992, the FDA published guidelines on cooperative manufacturing for biological products, recognizing four types of manufacturing arrangements: short supply, divided, shared, and contract. Short supply allows a licensed manufacturer to obtain from an unlicensed facility source materials that are declared to be in short supply.
From page 167...
... However, all steps of manufacturing performed at the unlicensed facility must be under the supervision and control of the licensed manufacturer. Contract arrangements are frequently used by biologics manufacturers, including vaccine manufacturers.
From page 168...
... The Drug Export Amendments establish three separate tracks for the export of unapproved drugs and unlicensed biological products. Under track 1, the FDA is authorized to approve the export of finished products that are not approved for marketing in the United States, but that have the same active ingredients as a product for which marketing approval is actively being sought in the United States.
From page 169...
... However, there must be evidence that the product is safe and effective for the intended use in the country to which it is to be exported. Finally, the act permits the FDA to approve the export of partially processed human biological products that are intended for further manufacture in one or more of the same set of 21 specified industrialized track 1 countries.

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