[Logo - CDER]                CHEMISTRY REVIEW TEMPLATE           [Logo - CDER]

            a.  Preparation................................................... ..............................................................................

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            b.  Specifications...............................................................................................................................

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       6.  Regulatory Specifications/Analytical Methods ..................................................................................

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            a.  Drug Substance Specifications & Tests ........................................................................................

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            b.  Purity Profile................................................................................................................................

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            c.  Microbiology ...............................................................................................................................

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       7.  Container / Closure System For Drug Substance Storage ....................................................................

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       8.  Drug Substance Stability ...................................................................................................................

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II.  DRUG PRODUCT ................................................................................................................................

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       1.  Components/Composition ..................................................................................................................

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       2.  Specifications & Methods For Drug Product Ingredients .....................................................................

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            a.  Active Ingredient(s) .....................................................................................................................

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            b.  Inactive Ingredients .....................................................................................................................

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       3.  Manufacturer ...................................................................................................................................

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       4.  Methods of Manufacturing and Packagingg [Packaging] .....................................................................

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            a.  Production Operations .................................................................................................................

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            b.  In-Process Controls & Tests ........................................................................................................

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            c.  Reprocessing Operations .............................................................................................................

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       5.  Regulatory Specifications and Methods For Drug Product ...................................................................

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            a.  Sampling Procedures ...................................................................................................................

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            b.  Regulatory Specifications And Methods ........................................................................................

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       6.  Container/Closure System .................................................................................................................

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       7.  Microbiology ....................................................................................................................................

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       8.  Drug Product Stability .......................................................................................................................

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III.  INVESTIGATIONAL FORMULATIONS ............................................................................................

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IV.  ENVIRONMENTAL ASSESSMENT ...................................................................................................

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V.   METHODS VALIDATION ..................................................................................................................

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VI.  LABELING .........................................................................................................................................

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VII. ESTABLISHMENT INSPECTION .....................................................................................................

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VIII. DRAFT DEFICIENCY LETTER ........................................................................................................

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