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

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

19

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

20

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

21

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

21

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

21

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

25

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

26

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

27

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

31

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

31

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

33

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

33

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

33

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

34

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

36

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

39

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

39

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

39

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

40

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

40

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

40

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

46

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

50

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

51

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

57

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

58

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

58

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

59

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

61

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

62