A-A-51267A
NOTE: When an inoculated carrier is chosen, product samples must also be tested as required by the USP.
Alternate method. Suppliers conducting sterility tests in a manner other than that indicated herein shall submit proof that the alternate method provides equal assurance concerning the sterility of the product. Requests for approval of any alternate method of testing for sterility shall be made to the Contracting Officer, and approval obtained before employment of the alternate method on a Government contract. “Dosimetric Release” as approved by FDA for gamma radiation sterilization is acceptable without prior approval by the contracting officer.
Product testing. Testing for sterility of the product after receipt by the Government shall be without a biological indicator and in accordance with the USP.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. 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.
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 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 Public Law 94-580 to the maximum extent practical.
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