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Sterilisation, decision tree

Morris JM. Sterilisation decision trees and implementation. PDA J Pharm Science Technol 1999 54 64-8. [Pg.108]

Morris JM (2000) Sterilisation decision trees development and implementation. PDA J Par Sci Technol 54 64-68... [Pg.694]

CPMP/QWP/054/98 corr Annex to note for guidance on development pharmaceutics—Decision trees for methods of sterilisation (February 1999, amended after February 2000)... [Pg.665]

EMEA/CVMP/065/99 final Decision trees for the selection of sterilisation methods (February 2000)... [Pg.665]

The European agency for the evaluation of medicinal products. In Decision Trees for the Selection of Sterilisation Methods London, 1998. [Pg.614]

Figure 1 Decision tree for sterilisation choices for non-aqueous liquid,semi-solid or dry powder products [23]. Figure 1 Decision tree for sterilisation choices for non-aqueous liquid,semi-solid or dry powder products [23].
According to the decision trees, where it is not possible to carry out terminal sterilisation by heating due to formulation instability, a decision should be made to utilise an alternative method of terminal sterilisation, filtration and/or aseptic processing. If this alternative route is taken, then a clear scientific justification for not using terminal heat sterilisation will be required in the NDA/MAA dossier. Commercial reasons will not be acceptable because terminal sterilisation offers the highest possible level of sterility assurance. [Pg.482]

See other pages where Sterilisation, decision tree is mentioned: [Pg.95]    [Pg.108]    [Pg.95]    [Pg.108]    [Pg.134]    [Pg.351]    [Pg.352]    [Pg.482]   
See also in sourсe #XX -- [ Pg.95 ]



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