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Satisfactory CGMP inspection

A move to a different manufacturing site, when it is a type of site routinely subject to FDA inspection, should be filed as a prior approval supplement if the site does not have a satisfactory CGMP inspection for the type of operatiorf being moved (see sections VI.B.l and 2). [Pg.524]

A change in the contract sterilization site for packaging components when the process is not materially different from that provided for in the approved application and the facility has a satisfactory CGMP inspection for the type of operation being perfonned. [Pg.527]

An applicant wants to move the manufacture of an immediate-release tablet (TCM) to a different manufacturing site that currently manufactures, and has satisfactory CGMP status for, capsules (CHG) and powders for oral solution (POW). This manufacturing site change should be filed in a prior approval supplement because the new manufacturing site doesn t have a satisfactory CGMP inspection for immediate-release tablets. [Pg.546]

See other pages where Satisfactory CGMP inspection is mentioned: [Pg.73]    [Pg.386]    [Pg.386]    [Pg.401]    [Pg.481]    [Pg.481]    [Pg.524]    [Pg.526]    [Pg.527]    [Pg.546]    [Pg.546]    [Pg.548]    [Pg.751]    [Pg.767]    [Pg.777]    [Pg.29]    [Pg.5]    [Pg.6]    [Pg.7]    [Pg.14]    [Pg.14]    [Pg.15]    [Pg.16]    [Pg.18]    [Pg.62]    [Pg.602]   
See also in sourсe #XX -- [ Pg.16 ]



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