Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
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Changes within the approved scope of the NIRS procedure are subject to GMP only.
- Changes outside of
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the approved scope of the NIRS procedure are subject to variation application.
- The definition of the
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scope is given in Section 4.1.1 of the guideline and the use of this scope to manage change control is
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further explained in Section 7 of the guideline.
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Table 1 gives the method scope for the approved NIRS procedure.
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Table 2 details those changes that would be considered WITHIN the scope of the procedure;
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therefore, maintained under GMP only.
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Table 3 details those changes that would be considered OUTSIDE of the scope of the procedure:
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therefore, subject to variation application.
- Proposed changes with a Type IB categorisation may be the subject of a
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post approval change management protocol, with consequential downgrade of the variation type.
- Additional interpretation specific to certain parameters for NIRS methods is given in Table 3 below.
- Type 1A variation (B.I.b.2.a or
Condition 1: at least equivalent method
B.II.d.2.a)
Equivalent to VNRA B.12.a for
veterinary productsparameters are used.
- The change in
statistical attributes would
therefore be considered under
the variation for the related
change. - tolerances)
under the related variation for
the change in reference method59
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an
NIRS Procedure
EMA/CHMP/CVMP/QWP/17760/2009 Rev 3Page 7/7