SUPAC definition

SUPAC means, at any time, FDA guidelines for scale-up and post-approval changes for manufacturing of drugs.
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SUPAC means Scale Up and Post Approval Changes.
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Examples of SUPAC in a sentence

  • For SUPAC Type I, II and III changes to the Specifications, Formulation or manufacturing process for FDA approved Standard Products, that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), EURAND and SCANDIPHARM must each agree to any Discretionary Manufacturing Changes and shall cooperate in making such changes, and each agrees that it shall not unreasonably delay or withhold its consent to such Discretionary Manufacturing Changes.

  • This Agreement may be terminated by HD with respect to any Product with respect to which a SUPAC has been obtained, upon thirty (30) days prior written notice to PAR.

  • PAR shall file the SUPAC with the FDA and shall provide REDDY with reasonable assistance to develop the manufacturing capability for the Reddy Group 6 Products at REDDY's current manufacturing facility..

  • PAR shall provide REDDY with reasonable assistance in the preparation of the SUPAC.

  • Purchase orders will be in full batch size quantities as specified in the NDA, or scalable within the scope of SUPAC guidelines in agreement with both parties.

  • CATALYTICA agrees to prepare the chemistry, manufacturing, and controls documentation necessary for the SUPAC supplement to transfer manufacture of the Product to CATALYTICA.

Related to SUPAC

  • Green means products, materials, methods and processes certified by a “Green Authority” that conserve natural resources, reduce energy or water consumption, avoid toxic or other polluting emissions or otherwise minimize environmental impact.

  • SUP means the Supervision Manual, part of the Handbook; and

  • Crown means the government of the United Kingdom (including the Northern Ireland Assembly and Executive Committee, the Scottish Executive and the National Assembly for Wales), including, but not limited to, government ministers and government departments and particular bodies, persons, commissions or agencies from time to time carrying out functions on its behalf;

  • Hookah means a water pipe and any associated products and devices which are used to produce fumes, smoke, and/or vapor from the burning of material including, but not limited to, tobacco, shisha, or other plant matter.

  • PAC means the personal access code or word used with Direct Services to access an Account.